2016 FDA Rule On E-Cigarettes

Vol.
81 Tuesday,
No. 90 May 10, 2016
Part III
Department of Health and Human Services

Food and Drug Administration
21 CFR Parts 1100, 1140, and 1143
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and
Cosmetic Act, as Amended by the Family Smoking Prevention and
Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco
Products and Required Warning Statements for Tobacco Products; Final
Rule
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VerDate Sep<11>2014 19:27 May 09, 2016 Jkt 238001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\10MYR3.SGM 10MYR3
28974 Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Rules and Regulations
DEPARTMENT OF HEALTH AND Products, Food and Drug B. Ingredient Listing and HPHC
HUMAN SERVICES Administration, 10903 New Hampshire Requirements (Sections 904 and 915)
Ave., Silver Spring, MD 20993, 877– C. Registration and Product Listing
Food and Drug Administration (Section 905)
287–1373, AskCTP@fda.hhs.gov.
D. Tobacco Health Document Submissions
SUPPLEMENTARY INFORMATION: (Section 904)
21 CFR Parts 1100, 1140, and 1143 E. Office of Small Business Assistance
Table of Contents
[Docket No. FDA–2014–N–0189] X. Regulation of Other Categories of Products
Executive Summary A. Nicotine in Newly Deemed Products
RIN 0910–AG38 I. Background B. Dissolvables
II. Legal Authority C. Gels
Deeming Tobacco Products To Be A. Summary of Legal Authority D. Pipe Tobacco
Subject to the Federal Food, Drug, and B. Responses to Comments Regarding Legal E. Waterpipe Tobacco
Cosmetic Act, as Amended by the Authority F. Additional Novel and Future Tobacco
Family Smoking Prevention and III. Use of Premarket Pathways for Newly Products
Tobacco Control Act; Restrictions on Deemed Products XI. Additional Automatic Provisions
the Sale and Distribution of Tobacco A. Background: The Three Pathways To Applicable to Newly Deemed Products
Market a New Tobacco Product A. Sections 902 and 903—Adulteration and
Products and Required Warning B. Interpretation of Substantial Misbranding
Statements for Tobacco Products Equivalence B. Sections 904 and 915—Ingredient
AGENCY: Food and Drug Administration, C. Comments on the Grandfather Date Listing and Reporting of HPHCs
D. Impact of Premarket Requirements C. Section 905—Registration and Listing
HHS.
E. Clinical Studies and PMTAs D. Section 911—Elimination of Low, Light,
ACTION: Final rule. F. Premarket Pathways and Continuum of and Mild, and Other Unauthorized
Risk Modified Risk Claims
SUMMARY: The Food and Drug G. Other Comments E. Section 919—User Fees
Administration (FDA) is issuing this IV. Implementation F. Tobacco Control Act section 102—
final rule to deem products meeting the A. Effective Date for Rule Prohibition Against Free Samples
statutory definition of ‘‘tobacco B. Compliance Periods for Certain XII. Requests for Additional Regulations
product,’’ except accessories of the Provisions Applicable to Newly Deemed Products
newly deemed tobacco products, to be C. Policy for Certain Regulatory A. Ban on Flavored Tobacco Products
subject to the Federal Food, Drug, and Requirements for All Manufacturers of B. Additional Access Restrictions
Cosmetic Act (the FD&C Act), as Newly Deemed Products C. Nicotine Exposure Warnings
amended by the Family Smoking D. Compliance Policy Regarding Certain XIII. Severability
Provisions and Small-Scale Tobacco XIV. Description of the Final Rule—Part 1100
Prevention and Tobacco Control Act Product Manufacturers A. Section 1100.1—Scope
(Tobacco Control Act). The Tobacco V. Premarket Review Requirements and B. Section 1100.2—Requirements
Control Act provides FDA authority to Compliance Policy C. Section 1100.3—Definitions
regulate cigarettes, cigarette tobacco, A. Compliance Policy for Premarket XV. Description of the Final Rule—Part 1140
roll-your-own tobacco, smokeless Review Requirements A. Section 1140.1—Scope
tobacco, and any other tobacco products B. Responses to Comments Regarding B. Section 1140.2—Purpose
that the Agency by regulation deems to Compliance Periods for Premarket C. Section 1140.3—Definitions
be subject to the law. With this final Review Requirements D. Section 1140.10—General
rule, FDA is extending the Agency’s VI. Components, Parts, and Accessories Responsibilities of Manufacturers,
A. Definitions Distributors, and Retailers
‘‘tobacco product’’ authorities in the B. Discussion of Requirements Associated E. Section 1140.14—Additional
FD&C Act to all other categories of With Components and Parts Responsibilities of Retailers
products that meet the statutory VII. Regulation of Cigars and Selection of F. Comments and Responses Regarding
definition of ‘‘tobacco product’’ in the Option 1 Minimum Age and Identification
FD&C Act, except accessories of such A. Health Risks of Premium Cigars Requirements
newly deemed tobacco products. This B. Youth and Young Adults Use Premium G. Comments and Responses Regarding
final rule also prohibits the sale of Cigars Vending Machines
‘‘covered tobacco products’’ to C. Patterns of Use Do Not Preclude Users XVI. Description of the Final Rule—Part 1143
individuals under the age of 18 and From Experiencing Negative Health A. Section 1143.1—Definitions
Effects B. Section 1143.3—Required Warning
requires the display of health warnings D. Responses to Other Cigar Comments Statement Regarding Addictiveness of
on cigarette tobacco, roll-your own VIII. Regulation of Electronic Nicotine Nicotine
tobacco, and covered tobacco product Delivery Systems (Including C. Section 1143.5—Required Warning
packages and in advertisements. FDA is E-Cigarettes) and the Continuum of Statements for Cigars
taking this action to reduce the death Nicotine-Delivering Products D. Section 1143.7—Language Requirements
and disease from tobacco products. In A. Terminology for Required Warning Statements
accordance with the Tobacco Control B. Prevalence E. Section 1143.9—Irremovable or
Act, we consider and intend the C. Toxicity and Nicotine in E-Liquid and Permanent Required Warning Statements
extension of our authorities over Aerosol F. Section 1143.11—Does Not Apply to
D. Quality Control Foreign Distribution
tobacco products and the various E. Misperceptions G. Section 1143.13—Effective Date
requirements and prohibitions F. Use as a Cessation Product H. Comments and Responses Regarding
established by this rule to be severable.
G. Modified Risk Claims Required Warning Statements

DATES: This rule is effective August 8, H. Dual and Polytobacco Use XVII. National Environmental Policy Act
2016. See section IV of this document I. Applicability of Section 901 XVIII. Analysis of Impacts
regarding compliance dates for certain J. Definitions XIX. Paperwork Reduction Act of 1995
provisions. K. Sottera Decision A. Responses to Comments Regarding
IX. Effect of Deeming Rule on Vape Shop Proposed Collection of Information
FOR FURTHER INFORMATION CONTACT: Manufacturers B. Existing Burdens Associated With
Gerie Voss or Katherine Collins, Office A. Premarket Requirements (Sections 910 Tobacco Products Currently Subject to
of Regulations, Center for Tobacco and 905) the FD&C Act (i.e., Cigarettes, Cigarette
Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Rules and Regulations 28975
Tobacco, Roll-Your-Own Tobacco, and using the terms ‘‘component’’ and or characteristics of a tobacco product.
Smokeless Tobacco) With Approved ‘‘part’’ interchangeably and without Examples of accessories also include
OMB Control Numbers emphasizing the distinction between the humidors or refrigerators that solely
C. Burdens Associated With Tobacco terms. FDA may clarify the distinctions control the moisture and/or temperature
Products Currently Subject to the FD&C
Act But Not Yet Approved by OMB
between ‘component’ and ‘part’ in the of a stored product and conventional
D. New Collections of Information That future. Specifically, ‘‘Component or matches and lighters that solely provide
Apply Only to Deemed Products Part’’ means ‘‘any software or assembly an external heat source to initiate but
XX. Executive Order 13132; Federalism of materials intended or reasonably not maintain combustion of a tobacco
XXI. Executive Order 13175; Tribal expected: (1) To alter or affect the product. An electric heater or charcoal
Consultation tobacco product’s performance, used for prolonged heating of waterpipe
XXII. References composition, constituents or tobacco is not an accessory because it is
Executive Summary characteristics; or (2) to be used with or maintaining the combustion of the
for the human consumption of a tobacco tobacco. Accessories of newly deemed
Purpose of the Rule product. The term excludes anything tobacco products are not included
Cigarettes, cigarette tobacco, roll-your- that is an accessory of a tobacco within the scope of this final rule,
own tobacco, and smokeless tobacco product.’’ Components and parts of the although accessories of cigarettes,
were immediately covered by FDA’s newly deemed tobacco products, but not cigarette tobacco, roll-your-own tobacco,
tobacco product authorities in chapter their related accessories, are included in and smokeless tobacco remain subject to
IX of the FD&C Act (21 U.S.C. 387 the scope of this final rule. The FDA’s tobacco product authorities. FDA
through 387u) when the Tobacco following is a nonexhaustive list of is not regulating accessories of newly
Control Act went into effect. For other examples of components and parts used deemed tobacco products because
kinds of tobacco products, the statute with electronic nicotine delivery accessories, unlike components or parts,
authorizes FDA to issue regulations systems (ENDS) (including e-cigarettes): are expected to have little direct impact
‘‘deeming’’ them to be subject to such E-liquids; atomizers; batteries (with or on the public health.
authorities. Consistent with the statute, without variable voltage); cartomizers This final deeming rule affords FDA
once a tobacco product is deemed, FDA (atomizer plus replaceable fluid-filled additional tools to reduce the number of
may put in place ‘‘restrictions on the cartridge); digital display/lights to illnesses and premature deaths
sale and distribution of a tobacco adjust settings; clearomisers, tank associated with tobacco product use.
product,’’ including age-related access systems, flavors, vials that contain e- For example, FDA will be able to obtain
restrictions and advertising and liquids, and programmable software. critical information regarding the health
promotion restrictions, if FDA Similarly, the following is a risks of newly deemed tobacco
determines the restrictions are nonexhaustive list of examples of products, including information derived
appropriate for the protection of the components and parts used with from ingredient listing submissions and
public health. This final rule has two waterpipe tobacco: Flavor enhancers reporting of harmful and potentially
purposes: (1) To deem all products that and the vials in which they are harmful constituents (HPHCs) required
meet the definition of ‘‘tobacco contained; hose cooling attachments; under the FD&C Act. As of the effective
product’’ under the law, except water filtration base additives date, persons who own or operate a
accessories of a newly deemed tobacco (including those which are flavored); domestic establishment engaged in the
product, and subject them to the tobacco flavored waterpipe tobacco charcoals manufacture, preparation,
control authorities in chapter IX of the and the wrappers or boxes that contain compounding, or processing of tobacco
FD&C Act and FDA’s implementing the charcoals; and bowls, valves, hoses, products (hereinafter, ‘‘manufacturing
regulations; and (2) to establish specific and heads. establishments’’) will be subject to the
restrictions that are appropriate for the FDA is defining ‘‘accessory’’ to mean registration requirements. FDA will thus
protection of the public health for the ‘‘any product that is intended or receive information on the location and
newly deemed tobacco products. In reasonably expected to be used with or number of manufacturing
accordance with section 5 of the for the human consumption of a tobacco establishments, which will allow the
Tobacco Control Act, we consider and product; does not contain tobacco and is Agency to establish effective
intend the extension of our authorities not made or derived from tobacco; and compliance programs. In addition, this
over tobacco products and the various meets either of the following: (1) Is not rule authorizes FDA to take enforcement
requirements and prohibitions intended or reasonably expected to action against manufacturers who sell
established by this rule to be severable. affect or alter the performance, and distribute products with
FDA is taking this action to reduce the composition, constituents, or unsubstantiated modified risk tobacco
death and disease from tobacco characteristics of a tobacco product or product (MRTP) claims, or false or
products. Deeming all ‘‘tobacco (2) is intended or reasonably expected to misleading claims on their labeling or
products’’ (including components and affect or maintain the performance, advertising, thus allowing for better-
parts but excluding accessories of the composition, constituents, or informed consumers and helping to
newly deemed products) to be subject to characteristics of a tobacco product but prevent the use of misleading
the FD&C Act will result in significant (i) solely controls moisture and/or campaigns targeted to youth
benefits for the public health. The final temperature of a stored product or (ii) populations. It will also prevent from
rule defines ‘‘component or part’’ and solely provides an external heat source entering the market new tobacco
‘‘accessory’’ to provide additional to initiate but not maintain combustion products that are not appropriate for the
clarity as to which products are subject of a tobacco product.’’ Examples of protection of public health, are not
to FDA’s tobacco product authority. accessories are ashtrays, spittoons, substantially equivalent to a valid
With respect to these definitions, FDA hookah tongs, cigar clips and stands and predicate product, or are not exempt
notes that ‘‘component’’ and ‘‘part’’ are pipe pouches, because they do not from substantial equivalence (SE).
separate and distinct terms within contain tobacco, are not derived from Finally, the newly deemed tobacco
chapter IX of the FD&C Act. However, tobacco, and do not affect or alter the products may be subject to future
for purposes of this final rule, FDA is performance, composition, constituents, regulations that FDA determines are
appropriate for the protection of public nicotine delivery through means (e.g., (which FDA is also applying to cigarette
health. via dermal absorption or intranasal tobacco and roll-your-own tobacco); and
spray) similar to currently marketed (3) prohibition of vending machine sales
Summary of the Major Provisions of the
medicinal nicotine products, but which of such products, unless the vending
Regulatory Action
are not drugs or devices. These products machine is located in a facility where
The final rule has two main sections: would be ‘‘tobacco products’’ and the retailer ensures that individuals
(1) Deeming provisions and (2) subject to FDA’s chapter IX authorities under 18 years of age are prohibited
additional provisions to protect public in accordance with this final deeming from entering at any time. The term
health. rule. ‘‘covered tobacco products’’ is defined
Deeming Provisions—After thorough Upon the effective date of this final as those products deemed to be subject
review of the comments and the rule (i.e., 90 days from the date of to the FD&C Act under section 1100.2 of
scientific evidence, FDA has concluded publication), the newly deemed title 21 of the Code of Federal
that Option 1 (including all cigars, products will be subject to the same Regulations (CFR), other than a
rather than a subset) more effectively FD&C Act provisions and relevant component or part that is not made or
protects the public health and, regulatory requirements to which derived from tobacco. We have slightly
therefore, has made that the scope of the cigarettes, cigarette tobacco, roll-your- modified the definition of ‘‘covered
final rule. Accordingly, this final rule own tobacco, and smokeless tobacco are tobacco products’’ from the notice of
deems all products meeting the subject, with respect to the following: proposed rulemaking (NPRM) to clarify
statutory definition of ‘‘tobacco (1) Enforcement action against that components or parts that are
product,’’ except accessories of the products determined to be adulterated ‘‘covered tobacco products’’ include not
newly deemed tobacco products, to be or misbranded (other than enforcement only those that contain tobacco or
subject to FDA’s tobacco product actions based on lack of a marketing nicotine, but also those that contain any
authorities under chapter IX of the authorization during an applicable tobacco derivative (i.e., we have
FD&C Act. Section 201(rr) of the FD&C compliance period); changed the NPRM definition, which
Act (21 U.S.C. 321(rr)), as amended by (2) Required submission of ingredient excluded ‘‘any component or part of a
the Tobacco Control Act, defines the listing and reporting of HPHCs; tobacco product that does not contain
term ‘‘tobacco product,’’ to mean ‘‘any (3) Required registration of tobacco nicotine or tobacco,’’ to exclude ‘‘any
product made or derived from tobacco product manufacturing establishments component or part of a tobacco product
that is intended for human and product listing; that is not made or derived from
consumption, including any (4) Prohibition against sale and tobacco’’ as stated in this final rule).
component, part, or accessory of a distribution of products with modified Effective Dates—The deeming
tobacco product (except for raw risk descriptors (e.g., ‘‘light,’’ ‘‘low,’’ provisions (i.e., those provisions that
materials other than tobacco used in and ‘‘mild’’ descriptors) and claims automatically apply to newly deemed
manufacturing a component, part, or unless FDA issues an order authorizing products) and minimum age and
accessory of a tobacco product)’’ and their marketing; identification and vending machine
does not mean ‘‘an article that is a drug (5) Prohibition on the distribution of restrictions are effective 90 days from
under subsection (g)(1), a device under free samples (same as cigarettes); and the date of publication of the final rule.
subsection (b), or a combination product (6) Premarket review requirements. The health warning requirements are
described in section 353(g) of this These actions will improve the public effective 24 months from the date of
title.’’ 1 Products that meet the statutory health by affording FDA critical publication of the final rule, with an
definition of ‘‘tobacco products’’ information regarding the health risks of additional 30-day period in which a
include currently marketed products such products; preventing new products manufacturer may continue to introduce
such as dissolvables not already from entering the market unless such into interstate commerce existing
regulated by FDA, gels, waterpipe marketing is appropriate for the inventory manufactured before the
tobacco, ENDS (including e-cigarettes, e- protection of public health, the products effective date that does not contain the
hookah, e-cigars, vape pens, advanced are found substantially equivalent to a required warning statements on
refillable personal vaporizers, and valid predicate product, or the products packaging.
electronic pipes), cigars, and pipe are found exempt from the SE This means that:
tobacco. requirements; and preventing the use of • After the effective date, no
In addition, this final rule deems any unsubstantiated modified risk claims, manufacturer, packager, importer,
additional current and future tobacco which may mislead consumers and lead distributor, or retailer of cigarette
products that meet the statutory them to initiate tobacco product use or tobacco, roll-your-own tobacco, cigars,
definition of ‘‘tobacco product,’’ except to continue using tobacco when they or other covered tobacco products may
accessories of such newly deemed would otherwise quit. advertise any such product if the
products, to be subject to FDA’s Additional Provisions—In addition to advertisement does not comply with
authorities under chapter IX of the the provisions in the FD&C Act and this rule;
FD&C Act. For example, FDA envisions implementing regulations that apply • After the effective date, no person
that there could be tobacco products automatically to the newly deemed may manufacture for sale or distribution
developed in the future that provide products, FDA has the authority to within the United States any such
invoke its other authorities under the product the package of which does not
1 FDA notes that some products falling within the Tobacco Control Act in regulating these comply with this rule;
FD&C Act’s definition of ‘‘tobacco product’’ may products. At this time, under section • Beginning 30 days after the effective
not be considered tobacco products for Federal
excise tax purposes (see 26 U.S.C. 5702(c)).
906(d) of the FD&C Act (21 U.S.C. date, a manufacturer may not introduce
Taxation of tobacco products, as defined by the 387f(d)), FDA is establishing three into domestic commerce, any such
Internal Revenue Code, falls under the jurisdiction restrictions for covered tobacco product, irrespective of the date of
of the U.S. Department of the Treasury/Alcohol and products: (1) Requirement for a manufacture, if its package does not
Tobacco Tax and Trade Bureau (TTB). Neither
FDA’s act of ‘‘deeming’’ nor any other FDA
minimum age of purchase; (2) comply with this rule (i.e., non-
regulations directly affect the taxation of any requirement for health warnings for compliant products manufactured prior
tobacco product. product packages and advertisements to the effective date may not be
distributed for retail sale after 30 days compliance/enforcement policies are Investigations Subcommittee, U.S.
following the effective date); not subject to the requirements that House of Representatives also called for
• After the effective date, a distributor govern notice-and-comment rulemaking. a more protective compliance period
or retailer may not sell, offer to sell, Prof’ls & Patients for Customized Care v. than the one contemplated in the
distribute, or import for sale or Shalala, 56 F.3d 592 (5th Cir. 1995) (a NPRM, arguing that the proposed
distribution within the United States compliance policy guide is not a compliance period ‘‘puts the nation’s
any such product the package of which substantive rule and not subject to the youth at risk’’ (Comment No. FDA–
does not comply with this regulation, Administrative Procedure Act’s (APA) 2014–N–0189–80119). Further, a
unless the covered tobacco product was notice-and-comment rulemaking); network of tobacco control policy and
manufactured prior to the effective date; Takhar v. Kessler, 76 F.3d 995, 1002 legal specialists expressed concern
and (9th Cir. 1996) (FDA compliance policy regarding the effect of continued
• After the effective date, however, a guides were not required to go through marketing of tobacco products that have
retailer may sell covered tobacco notice-and-comment procedures). But not been reviewed under the applicable
products in packages that do not have because the relevant time periods are of public health standards of the Tobacco
a required warning if the retailer obvious interest, FDA laid out its Control Act (Comment No. FDA–2014–
demonstrates it falls outside the scope anticipated compliance policy in the N–0189–81044). FDA also received
of this rule as described in 21 CFR NPRM, and for similar reasons, is comments suggesting that the agency
1143.3(a)(3) and 1143.5(a)(4). announcing its revised compliance should stagger the compliance periods
Compliance Policy for Premarket policy here, rather than in a separate for different product classes based on
Review—Manufacturers of newly guidance document.) As a result of the continuum of risk, with ENDS
deemed products that are ‘‘new tobacco FDA’s compliance policy, we expect having a longer compliance period than
products’’ as defined in section that many manufacturers will keep their other product classes (e.g., Comment
910(a)(1) of the FD&C Act will be products on the market beyond the No. FDA–2014–N–0189–81859;
required to obtain premarket effective date of this final rule. Comment No. FDA–2014–N–0189–
authorization of their products through However, if a manufacturer of a product 10852). FDA also received comments
one of three pathways—SE., exemption and new data regarding the effect of
is unable to support an SE claim for its
from SE., or premarket tobacco product
product (e.g., is unable to identify a flavored tobacco products on youth and
applications (sections 905 and 910 of
valid predicate, or does not submit an young adult use.
the FD&C Act). As stated in the NPRM,
SE report with a valid predicate within FDA understands that the appeal of
we understand that, for some newly
the compliance period, or does not flavors and use of flavored tobacco
deemed tobacco products, particularly
receive authorization within a products have an important role in the
novel products, there may not be
continued compliance period) and does initiation and continued use of tobacco
appropriate predicate products that
not obtain authorization under one of products, and in the health risks
were on the market on February 15,
the other available marketing pathways associated with use of these products.
2007, to support a SE claim.
Accordingly, in the NPRM, FDA before the end of an applicable Based on all of these comments, we
contemplated a compliance period of 24 compliance period, such products have determined that exercising
months after the effective date of the remaining on the market will be subject enforcement discretion indefinitely
final rule for the submission of to enforcement (e.g., seizure, injunction) could put youth and young adults at
applications for all newly deemed, new for failure to have a marketing risk for tobacco-related death and
tobacco products under all three authorization under sections 905 and disease. However, we recognize that the
marketing pathways—premarket 910 of the FD&C Act. availability of alternatives to traditional
tobacco applications (PMTAs), SE FDA’s NPRM included detailed tobacco flavors in some products (e.g.,
reports, and SE exemption requests.2 requests for comments on different ENDS) may potentially help some adult
FDA carefully considered numerous possible compliance policy approaches. users who are attempting to transition
comments regarding the contemplated 79 FR at 23175–77. FDA received many away from combusted products.
compliance period. Many comments comments on these compliance-policy Furthermore, at least some flavored
expressed concern that newly deemed, issues. For example, comments jointly combusted products are likely to be
new tobacco products would remain submitted by 24 health and medical ‘‘grandfathered’’ and therefore would
available and could continue to be organizations stated that the remain on the market regardless of the
marketed indefinitely without scientific contemplated 24-month compliance compliance period provided in the
review. Other comments expressed period and indefinite period of preamble. Taking into consideration all
concern, and some submitted data, continued marketing during FDA review of the comments on the compliance
regarding the effect that flavors have on included in the NPRM would prolong period and flavors, we are establishing
youth and young adult use of tobacco the public’s exposure to products that staggered compliance periods. This
products. FDA also received comments contain nicotine, a highly addictive approach will enable FDA to balance
and data regarding the potential for substance, and that do not meet the concerns regarding the extended
some net public health benefits that statutory standard for the grant of a availability of all newly deemed, new
could accrue if flavored ENDS remain marketing order (Comment No. FDA– tobacco products without scientific
available. After carefully considering all 2014–N–0189–79772.). They stated that review, concerns regarding flavored
of these comments, FDA here this approach would allow tobacco products’ appeal to youth, and
announces a revised compliance policy manufacturers to market the newly emerging evidence that some adults may
as well as the final rule. (Agency deemed products in ways that appeal to potentially use certain flavored tobacco
youth and to manipulate the content of products to transition away from
2 Although the NPRM did not explicitly include these products in uncontrolled ways for combusted tobacco use. FDA is
SE exemption requests as one of the marketing an indefinite period (id.). Ranking establishing staggered initial
pathways that applicants could utilize within a
compliance period, FDA did intend for its
minority members of the Energy and compliance periods based on the
contemplated 24-month compliance period to be Commerce Committee, Health expected complexity of the applications
available for all marketing pathways. Subcommittee, and Oversight and to be submitted, followed by continued
compliance periods for FDA review request if, for example, the application FD&C Act).3 This may possibly include
such that our exercise of enforcement is incomplete. For newly deemed a predicate that is in a different category
discretion will end twelve months after tobacco products using the SE pathway, or subcategory than the new product
each initial compliance period. In other this continued compliance period will that is the subject of the SE report.
words, manufacturers of all newly close 30 months after the effective date While FDA currently does not have a
deemed, new tobacco products will of part 1100 of this final deeming rule policy that limits comparisons to the
have a 12-, 18- or 24-month initial (i.e., 12 months after the 18-month same category, we do see cross-category
compliance period in which to prepare initial compliance period closes for comparisons as more challenging for an
applications for marketing submission and receipt of SE Reports). applicant and we may express
authorization, as well as a 12-month For newly deemed tobacco products limitations on such comparisons in the
continued compliance period after those using the PMTA pathway, this future, if they become warranted as we
dates in which to obtain authorization continued compliance period will close gain experience regulating newly
from FDA (resulting in total compliance 36 months after the effective date (i.e., deemed products. FDA also is
periods of 24, 30, or 36 months). After 12 months after the 24-month continuing to research e-cigarettes, other
the close of the continued compliance compliance period closes for ENDS, and heated cigarette products
period, products will be subject to submission and receipt of PMTAs). Any that likely were on the market ‘‘as of’’
enforcement unless they are such newly deemed tobacco product for (i.e., on) February 15, 2007.
grandfathered or are the subject of a which an application under one of the Additionally, FDA has determined that
marketing authorization order. FDA’s three marketing pathways has not been some e-cigarettes and other ENDS were
revised compliance policy for premarket submitted within 24 months from the manufactured in 2006 and commercially
review—resulting in products remaining effective date of part 1100 of this final marketed in the United States in early
on the market while manufacturers seek deeming rule will not benefit from this 2007. In particular, we have identified
review but also contemplating an end to an ENDS product that may have been on
continued compliance policy and will
the continued compliance policy—will the market on February 15, 2007. This
be subject to enforcement as of that date.
balance the public health concerns product may possibly be able to serve as
In addition, once the respective
raised in the comments, allow the a valid predicate for purposes of the SE
continued compliance period ends for
Agency to more efficiently manage the pathway. The burden of demonstrating
flow of incoming applications, and products with applications submitted that a valid predicate exists rests with
encourage high-quality premarket according to this policy, products the manufacturer submitting a SE
submissions from applicants. remaining on the market without report. To facilitate the determination
According to this revised compliance premarket authorizations in effect, even that a product is eligible to serve as a
policy, for newly deemed products that if the product has a pending application valid predicate, any individual who has
are on the market on the effective date that was originally submitted by its evidence that an e-cigarette or other
of this final rule and were not on the respective initial compliance deadline ENDS was commercially marketed in
market on February 15, 2007, FDA is set forth previously in this document, the United States on February 15, 2007,
providing a 12-month initial compliance will be subject to enforcement. may submit a stand-alone grandfather
period for manufacturers to submit (and However, if at the time of the submission to FDA (See final guidance,
FDA to receive) an SE exemption conclusion of the continued compliance ‘‘Establishing That a Tobacco Product
request, an 18-month initial compliance period, the applicant has provided the Was Commercially Marketed in the
period for manufacturers to submit (and needed information and review of a United States as of February 15, 2007’’
FDA to receive) SE applications, and a pending marketing application has (79 FR 58358, September 29, 2014)).
24-month initial compliance period for made substantial progress toward (Based on FDA’s experiences to date,
manufacturers to submit (and FDA to completion, FDA may consider, on a and since stand-alone grandfather
receive) a PMTA. case-by-case basis, whether to defer submissions are purely voluntary, FDA
If manufacturers submit (and FDA enforcement of the premarket does not anticipate that many
receives) the applications during their authorization requirements for a manufacturers will make such
respective compliance periods, FDA, for reasonable time period. submissions, but this option is
a certain period of time as discussed in Regarding concerns as to the inability available.) Regardless of the predicate
the following paragraph, intends to to use the SE pathway for certain selected for comparison, manufacturers
continue the compliance policy and products, FDA notes that an applicant are responsible for providing scientific
does not intend to initiate enforcement data adequate to demonstrate that, in
may use as a predicate any tobacco
action for these products remaining on the case of an SE report, the
product commercially marketed in the
the market without FDA authorization. characteristics of the new product are
For newly deemed tobacco products United States as of February 15, 2007,
or previously found substantially the same as the predicate or, if the
using the SE Exemption pathway, this characteristics are different, that these
continued compliance period (i.e., the equivalent (note that we interpret the
phrase ‘‘as of’’ February 15, 2007, as differences do not cause the new
time during which FDA does not intend product to raise different questions of
to enforce the premarket review meaning that the tobacco product was
public health. We encourage interested
requirements) will close 24 months after commercially marketed (other than
parties to review the applications FDA
the effective date of part 1100 of this exclusively in test markets) in the
final deeming rule (i.e.,12 months after United States on February 15, 2007. If 3 FDA Guidance states that ‘‘[i]f you cannot
the 12-month initial compliance period your tobacco product had been provide documentation specifically dated on
closes for submission and receipt of SE commercially marketed in the United February 15, 2007, FDA suggests you provide
States before February 15, 2007, but was documentation of commercial marketing for a
exemption requests). The earlier reasonable period of time before and after February
submission period for the SE exemption not commercially marketed on that date, 15, 2007.’’ Guidance for Industry entitled
pathway is intended to allow the it is not a grandfathered product and ‘‘Establishing That a Tobacco Product Was
manufacturer time to consider other may not be commercially marketed Commercially Marketed in the United States as of
February 15, 2007 (79 FR 58358, Sept. 29, 2014),
pathways if the exemption request is unless you obtain a marketing The guidance also provides examples of sources of
denied or if FDA refuses to accept the authorization under section 910 of the evidence, e.g., bills of lading.
posts on http://www.fda.gov for product package. This required warning means of addressing the premarket
examples of products that do not raise must be printed using the same authorization requirements for newly
different questions of public health specifications in § 1143.3(a)(1) and (2) deemed ENDS products, including
when compared with the specified (which provide the specifications for the recommendations for exposure
predicate product. addiction warning). In such cases, the warnings and child-resistant packaging
Vape Establishments Acting as carton, outer container, wrapper, or tag that would help to support a showing
Manufacturers—Several comments would serve as one of the principal that the marketing of a product is
asked FDA to clarify whether e-cigarette display panels. appropriate for the protection of public
retail stores and vape establishments are Reproductive Health Warning for health.
considered ‘‘tobacco product Cigars—In the proposed deeming rule, Requests for Additional Regulations
manufacturers’’ under the FD&C Act. In FDA proposed to require four of the five Applicable to Newly Deemed Products—
response, FDA has explained that warnings already included on most In the NPRM, FDA noted that, once the
establishments that mix or prepare e- cigar packages and in most cigar products were deemed, the Agency
liquids or create or modify aerosolizing advertisements as a result of settlement could issue additional regulations
apparatus for direct sale to consumers agreements between the Federal Trade applicable to newly deemed products,
are tobacco product manufacturers Commission (FTC) and the seven largest including product standards under
under the definition set forth in the U.S. cigar manufacturers (hereinafter, section 907 of the FD&C Act (21 U.S.C.
FD&C Act and, accordingly, are subject ‘‘FTC consent decrees’’). (See, e.g., In re 387g). FDA received many suggestions
to the same legal requirements that Swisher International, Inc., Docket No. for additional regulations that should
apply to other tobacco product C–3964.) FDA did not propose to apply to the newly deemed products.
manufacturers. require the fifth warning (SURGEON FDA is taking these comments under
Revisions to Health Warning GENERAL WARNING: Tobacco Use advisement and considering whether to
Requirements—FDA is finalizing this Increases the Risk of Infertility, issue NPRMs for such provisions.
deeming rule with a few changes to the Stillbirth and Low Birth Weight), but Compliance Policy Regarding Certain
proposed health warning requirements asked for comments regarding this Provisions and Small-Scale Tobacco
for newly deemed products. For decision. Upon further consideration, Product Manufacturers—In the NPRM,
example, FDA has slightly revised the FDA has decided to require a fifth FDA requested comment on the ability
nicotine warning statement to read: warning regarding reproductive health of small manufacturers of newly
‘‘WARNING: This product contains effects and cigar use specifically, which deemed tobacco products to fully
nicotine. Nicotine is an addictive reads ‘‘WARNING: Cigar use while comply with the requirements of the
chemical.’’ The alternative warning pregnant can harm you and your baby.’’ FD&C Act and how FDA might be able
statement for products that do not This requirement is supported by to address those concerns. Considering
contain nicotine (i.e., no nicotine at existing scientific evidence and is the comments and FDA’s finite
detectable levels) is revised to read: appropriate for the protection of the enforcement resources, the Agency’s
‘‘This product is made from tobacco.’’ public health. However, because the view is that those resources may not be
We have also provided additional general statement ‘‘Tobacco smoke best used in immediately enforcing
language explaining the process for self- increases the risk of infertility, stillbirth certain provisions of this rule against
certifying that the product does not and low birth weight’’ is also a true certain manufacturers that are small-
contain nicotine, which must be statement, and because scientific scale tobacco product manufacturers
submitted to FDA, and the evidence demonstrates that cigar smoke and that may need additional time to
recordkeeping recommendations for this is similar in content and effects to comply with certain requirements of the
self-certification. E-liquids that do not cigarette smoke, FDA is allowing the use FD&C Act. Generally, for purposes of
contain tobacco or nicotine or are not of the reproductive health warning this new compliance policy in which
derived from tobacco or nicotine do not required by the FTC consent decrees as FDA is specifying additional periods of
meet the definition of ‘‘covered tobacco an optional alternative to the fifth FDA time for such manufacturers to comply
product,’’ as described throughout this warning. FDA expects that providing with certain provisions (i.e., additional
final rule, and will not be required to the optional alternative will benefit time to respond to SE deficiency letters,
carry an addiction warning or to submit entities bound by the FTC consent an additional six-month compliance
a self-certification. In addition, we have decrees. period for the tobacco health document
added language to clarify that the Nicotine Exposure Warning and submission requirements, and
warning statements on packages must be Child-Resistant Packaging—After additional time to submit ingredient
printed in at least 12-point font size to reviewing the comments, FDA listings, as discussed in Section IV.D).
be conspicuous and legible. recognizes the importance of alerting As with manufacturers generally, these
Further, we have added a provision to consumers to, and protecting children small-scale tobacco manufacturers will
indicate that a product package too from, the hazards from ingestion of, and also benefit from additional assistance
small or otherwise unable to eye and skin exposure to, e-liquids with their marketing applications,
accommodate a label with sufficient containing nicotine. Toward that end, including: a Regulatory Health Project
space to bear such information will be FDA issued an advance NPRM Manager so that they have a single point
exempt from the requirements to place (ANPRM) prior to this deeming rule (80 of contact in FDA’s Center for Tobacco
the warning statement directly on FR 51146 (2015)), seeking comments, Products (CTP’s) Office of Science (OS)
packages (as required in § 1143.3(a)(1)), data, research, or other information that for questions about their marketing
as long as the warning requirements may inform regulatory actions FDA may applications; an appeals process for
enumerated in § 1143.3(a)(2) and (d) are take with respect to a nicotine exposure denial of marketing applications (of
met. For instance, for small packages, warning and child-resistant packaging. which one small business has already
the warning statement must appear on In addition, elsewhere in this issue of taken advantage); and staff from CTP’s
the two principal display panels on the the Federal Register, FDA has made Office of Compliance and Enforcement
outer carton or other outer container or available draft guidance, which when (OCE), who assist such businesses in
wrapper or on a tag otherwise final will describe FDA’s current helping them to identify documents that
permanently affixed to the tobacco thinking regarding some appropriate may be used to establish that their
predicate products were on the market also intends to issue a guidance invalidate, restrain, enjoin, or suspend
on February 15, 2007. Further, CTP’s regarding HPHC reporting under section any provision of this final rule, FDA
OCE will continue to assist small-scale 904(a)(3), and later a testing and would conclude that the remaining
tobacco product manufacturers in their reporting regulation as required by parts continue to be valid. As stated in
submission of rotational warning plans section 915, with enough time for section 5 of the Tobacco Control Act, if
for FDA approval and to provide a manufacturers to report given the 3-year certain applications of this rule to
system to assist such businesses in compliance period for HPHC reporting. persons or circumstances (discussed in
navigating the regulatory requirements Section 904(a)(3) requires the the preamble or otherwise) are held to
of FDA. FDA considers a ‘‘small-scale submission of a report listing all be invalid, application of such
tobacco product manufacturer’’ to be a constituents, including smoke provisions to any other person or
manufacturer of any regulated tobacco constituents identified as harmful or circumstance will not be affected and
product that employs 150 or fewer full- potentially harmful (HPHC) by the will continue to be enforced. Each
time equivalent employees and has Secretary. Section 915 requires the provision of the rule is independently
annual total revenues of $5,000,000 or testing and reporting of the constituents, supported by data and analysis as
less. In formulating our thinking on ingredients, and additives the Secretary described or referenced in this preamble
what a small-scale tobacco product determines should be tested to protect and, if issued separately, would remain
manufacturer is for purposes of this the public health. The section 915 a proper exercise of FDA authority.
policy, FDA has considered all available testing and reporting requirements
data on employment, revenues, apply only after FDA issues a regulation Costs and Benefits
production volume and other details of implementing that section, which it has
This final rule deems all products
operation for current manufacturers of not yet done. Until these testing and
meeting the statutory definition of
newly deemed products. FDA considers reporting requirements have been
‘‘tobacco product,’’ except accessories of
a manufacturer to include each entity established, newly deemed tobacco
a newly deemed tobacco product, to be
that it controls, is controlled by, or is products (and currently regulated
subject to chapter IX of the FD&C Act.
under common control with. To help tobacco products) are not subject to the
make FDA’s individual enforcement testing and reporting provisions found This final rule also finalizes additional
decisions more efficient, a manufacturer under section 915. As noted elsewhere provisions that would apply to certain
may voluntarily submit information in this document, FDA does not intend newly deemed products as well as to
regarding employment and revenues.4 to enforce the reporting requirements certain other tobacco products. Once
Policy for Certain Regulatory under section 904(a)(3) for newly deemed, tobacco products become
Requirements for All Manufacturers of deemed products before the close of the subject to the FD&C Act and its
Newly Deemed Products—Although 3-year compliance period, even if the implementing regulations. The FD&C
FDA maintains that all of the automatic HPHC guidance and the section 915 Act requirements that will apply to
provisions are important given that all regulation are issued well in advance of newly deemed products include
tobacco products have inherent risks, that time. establishment registration and product
FDA recognizes that compliance with Severability—In accordance with listing, ingredient listing, HPHC testing
many of the automatic provisions may section 5 of the Tobacco Control Act, and reporting, premarket submissions
be challenging at first for entities that FDA considers and intends the prior to the introduction of new
are new to Federal public health extension of its authorities over all products, and labeling requirements.
regulation. In addition, FDA expects tobacco products and the various Free samples of newly deemed tobacco
that it will obtain necessary information requirements and prohibitions products will also be prohibited. The
from its regulation of finished tobacco established by this rule to be severable. additional provisions of this final rule
products. As a result, FDA has It is FDA’s interpretation and position include minimum age and identification
established a compliance policy for that the invalidity of any provision of requirements, vending machine
premarket submission and for obtaining this rule shall not affect the validity of restrictions, and required warning
authorization with respect to certain any other part of this rule. In the event statements for packages and
components and parts of newly deemed any court or other lawful authority were advertisements.
tobacco products. We note that FDA to temporarily or permanently
TABLE 1—SUMMARY OF QUANTIFIED COSTS OVER 20 YEARS

[$ million]
Lower bound Primary Upper bound Lower bound Primary Upper bound
(3%) (3%) (3%) (7%) (7%) (7%)
Present Value of Private Sector Costs .... 517.7 783.7 1,109.8 450.4 670.9 939.8
Present Value of Government Costs 1 ..... 204.6 204.6 204.6 145.7 145.7 145.7
Present Value of Total Costs ................... 722.3 988.2 1,314.4 596.1 816.5 1,085.4
Annualized Value of Private Sector Costs 34.8 52.7 74.6 42.5 63.3 88.7
Annualized Value of Government Costs 1 13.8 13.8 13.8 13.8 13.8 13.8
Annualized Value of Total Costs ............. 48.5 66.4 88.3 56.3 77.1 102.5
1 FDA costs represent an opportunity cost, but this rule will not result in changes to overall FDA accounting costs, the size of the Federal budg-
et, or the total amount of tobacco industry user fees.
4 FDA notes that our current thinking regarding established by the Small Business Administration of the potentially unique interests of the smallest
‘‘small-scale tobacco product manufacturer’’ for or the Tobacco Control Act’s definition of a ‘‘small tobacco product manufacturers as considered in
purposes of this compliance policy differs from tobacco product manufacturer.’’ FDA notes that its light of the Agency’s statutory obligations regarding
definitions of ‘‘small manufacturer’’ or ‘‘small current thinking reflects an evaluation of all the protection of public health.
tobacco product manufacturer’’ that pertain in available data regarding manufacturers of newly
several other contexts, including definitions deemed tobacco products, as well as careful review
The direct benefits of making each of adulthood’’ (Ref. 3). These youth pharmacokinetic properties of inhaled
the newly deemed tobacco products develop physical dependence and nicotine can be similar to nicotine
subject to the requirements of chapter IX experience withdrawal symptoms when delivered by combusted tobacco
of the FD&C Act are difficult to quantify, they try to quit smoking (id.). As a products. Thus, inhaled nicotine from a
and we cannot predict the size of these result, addiction to nicotine is often non-combustible product may be as
benefits at this time. Table 1 lifelong (Ref. 4), and youth and young addictive as inhaled nicotine delivered
summarizes the quantified costs of this adults generally ‘‘underestimate the by combusted tobacco products.
final rule over 20 years. For the reasons tenacity of nicotine addiction and Researchers recognize that the effects
provided in the preamble and analysis overestimate their ability to stop from nicotine exposure by inhalation
of impacts, FDA has concluded that the smoking when they choose’’ (Ref. 5). For without combustion are likely not
benefits of the final rule justify the example, in a study of over 1,200 sixth responsible for the high prevalence of
costs. Among other effects, new grade students who inhaled tobacco tobacco-related death and disease in this
products will be subject to an evaluation products, 58.5 percent had lost country (Refs. 10, 11). Although
to ensure they meet the appropriate autonomy over their tobacco use (i.e., nicotine itself has not been shown to
public health standard for the pathway had difficulty trying to quit) (Ref. 6). cause the chronic disease associated
before they can be marketed, labeling One survey also revealed that ‘‘nearly 60 with tobacco use, the 2014 Surgeon
cannot contain misleading statements, percent of adolescents believed that
General’s report noted that there are still
and FDA will be made aware of the they could smoke for a few years and
risks associated with nicotine (Ref. 9 at
ingredients in newly deemed tobacco then quit’’ (Ref. 7). Research conducted
111). For example, nicotine at high
products. If, without the final rule, new in animal models has indicated that
products would pose substantially exposure to substances such as nicotine enough doses has acute toxicity (id.).
greater health risks than those already can disrupt prenatal brain development Research in animal models have
on the market, the premarket and may have long-term consequences demonstrated that nicotine exposure
requirements made effective by this on executive cognitive function and on during fetal development may have
final rule would keep such products the risk of developing a substance abuse lasting adverse consequences for brain
from appearing on the market and disorder and various mental health development (id.). Nicotine also
worsening the health effects of tobacco problems as an adult (Ref. 8), and this adversely affects maternal and fetal
product use. The warning statements exposure to nicotine can also have long- health during pregnancy, contributing to
required by this final rule will help term results on decreasing attention multiple adverse outcomes such as
consumers better understand and performance and increasing impulsivity preterm delivery and stillbirth (id.;
appreciate the risks and characteristics which could promote the maintenance citing Refs. 12, 13). Further, data from
of tobacco products. of nicotine use behavior (id.). studies of mice also suggest that
The Surgeon General also emphasizes nicotine exposure during adolescence
I. Background that ‘‘nicotine addiction develops as a may have lasting adverse consequences
Cigarettes, cigarette tobacco, roll-your- neurobiologic adaptation to chronic for brain development (id.). Some
own tobacco, and smokeless tobacco nicotine exposure,’’ suggesting that the studies in animal models also have
were immediately covered by FDA’s pattern of tobacco product use (e.g., found that nicotine can have
tobacco product authorities in chapter frequency of using the product) is a detrimental effects on the
IX of the FD&C when the Tobacco factor in the facilitation of nicotine cardiovascular system and potentially
Control Act went into effect. For other addiction (Ref. 9 at 112). The Surgeon disrupt the central nervous system
tobacco products, the statute authorized General also noted ‘‘all forms of nicotine (Refs. 14, 15).
FDA to issue regulations ‘‘deeming’’ delivery do not pose an equal risk in ‘‘Since the 1964 Surgeon General’s
them to be subject to such authorities. establishing and maintaining addiction’’ report, comprehensive tobacco control
Consistent with the statute, once a and this may be because the
tobacco product is deemed, FDA may programs and policies have been proven
pharmacokinetics of various nicotine
put in place ‘‘restrictions on the sale effective for controlling tobacco use’’
containing products differ (id.). The
and distribution of a tobacco product,’’ (Ref. 9 at 36). Accordingly, FDA is
FDA-approved nicotine patch is an
if FDA determines the restrictions are issuing this final rule to serve two
example of slow absorption and once-a-
appropriate for the protection of the purposes: (1) To deem products that
day dosing which results in minimal
public health (21 U.S.C. 387f(d)(1)). potential for addiction (Ref. 2 at 113). In meet the definition of ‘‘tobacco
The Surgeon General has long 1988, the Surgeon General recognized product’’ under the law, except
recognized that the addictive nature of that the ultimate levels of nicotine accessories of newly deemed tobacco
tobacco products is due to the presence absorbed into the blood from tobacco products, and subject them to the
of highly addictive nicotine that can be products on the market at that time can tobacco control authorities in the FD&C
absorbed into the bloodstream (see, e.g., be similar in magnitude regardless of Act; and (2) to establish specific
Ref. 1 at 6–9). While the amount of the product forms used to deliver restrictions that are appropriate for the
nicotine delivered and the means nicotine (Ref. 1). For example, research protection of the public health for the
through which it is delivered can either has shown that oral use of smokeless newly deemed tobacco products. To
reduce or enhance nicotine’s potential tobacco products that do not emit smoke satisfy these purposes, FDA proposed
for abuse and physiological effects (Ref. results in ‘‘high venous concentrations two options (Option 1 and Option 2),
2 at 113), nicotine is addictive. In of nicotine equal to those for use of which provided two alternatives for the
general, the quicker the delivery, rate of cigarettes’’ (Ref. 2 at 113). scope of the deeming provisions and,
absorption, and attainment of peak FDA believes that the inhalation of consequently, the application of the
concentrations of nicotine, the greater nicotine (i.e., nicotine without the additional specific provisions. Under
the potential for addiction (id.). products of combustion) is of less risk Option 1, all products meeting the
The Surgeon General reported that to the user than the inhalation of definition of a ‘‘tobacco product,’’
‘‘most people begin to smoke in nicotine delivered by smoke from except accessories of newly deemed
adolescence and develop characteristic combusted tobacco products. However, tobacco products, would be deemed.
patterns of nicotine dependence before limited data suggest that the Option 2 was the same as Option 1,
except a subset of cigars known as II. Legal Authority of the FD&C Act). Section 903(a)(7)(B) of
‘‘premium cigars’’ would be excluded. the FD&C Act also provides that a
A. Summary of Legal Authority
Currently, tobacco products tobacco product is misbranded if it is
As set forth in the preamble to the sold or distributed in violation of a
unregulated by FDA are widely NPRM (79 FR 23142 at 23145), the regulation prescribed under section
available and come in many forms, Tobacco Control Act provided FDA with 906(d) of the FD&C Act.
including cigars, pipe tobacco, the authority to regulate tobacco In addition, section 701(a) of the
waterpipe tobacco, liquids (e-liquids) products by, among other things, adding FD&C Act (21 U.S.C. 371(a)) provides
for ENDS (the most popular of which chapter IX to the FD&C Act. Section 901 FDA with authority to issue regulations
are electronic cigarettes, but also of the FD&C Act (21 U.S.C. 387a) for the efficient enforcement of the
include e-hookah, e-cigars, vape pens, provides that this new chapter (Chapter FD&C Act.
personal vaporizers, and electronic IX—Tobacco Products) applies to all
pipes), liquid nicotine that is made or B. Responses to Comments Regarding
cigarettes, cigarette tobacco, roll-your-
derived from tobacco, nicotine gels, and Legal Authority
own tobacco, and smokeless tobacco
certain dissolvable tobacco products and to any other tobacco products that FDA received comments on a wide
(i.e., dissolvable products that do not the Secretary of Health and Human range of legal issues, including FDA’s
currently meet the definition of Services by regulation deems to be authority to deem tobacco products
‘‘smokeless tobacco’’ in section 900(18) subject to this chapter. In accordance subject to the FD&C Act and
of the FD&C Act (21 U.S.C. 387(18)) with section 901 of the FD&C Act, FDA constitutional issues that may be
because they do not contain cut, ground, issued a NPRM to extend FDA’s implicated by the NPRM. FDA carefully
powdered, or leaf tobacco and instead ‘‘tobacco product’’ authorities to considered these comments and
contain nicotine extracted from products that meet the statutory concludes that the Agency has authority
tobacco). Upon implementation of this definition of ‘‘tobacco product’’ in to deem the tobacco products covered
final rule, currently unregulated tobacco section 201(rr) of the FD&C Act,5 except under this final rule. FDA is not aware
products and future products meeting the accessories of these tobacco of other legal concerns from comments
the definition of ‘‘tobacco product’’ products, and provided two separate that prevent the Agency from taking the
options as to the scope of cigar products actions included in this final rule. A
under section 201(rr) (except accessories
that would be deemed subject to FDA’s summary of comments regarding legal
of newly deemed tobacco products) will
tobacco authorities. FDA is selecting authority, and FDA’s responses, follows.
be subject to chapter IX of the FD&C
Act. Option 1 deeming all tobacco products, 1. Section 901 Authority
including premium cigars, except the
FDA issued a proposed deeming rule (Comment 1) Generally, the comments
accessories of the newly deemed
on April 25, 2014 (79 FR 23142). We did not challenge FDA’s authority under
products, with this final rule.
received over 135,000 comments on the In addition, section 906(d)(1) of the section 901 of the FD&C Act, but at least
NPRM. Comments were received from FD&C Act authorizes FDA to require one comment argued that section 901
tobacco product manufacturers, restrictions on the sale and distribution does not grant FDA the authority to
retailers, academia, medical of a tobacco product, if the Agency deem, ‘‘in a sweeping manner,’’ all
professionals, local governments, determines that ‘‘such regulation would products (excluding accessories) that
advocacy groups, and consumers. To be appropriate for the protection of the meet the statutory definition of ‘‘tobacco
make it easier to identify comments and public health.’’ FDA has determined product.’’ The comment argued that
our responses, the word ‘‘Comment,’’ in that the additional restrictions included Congress intended to grant FDA
parentheses, will appear before each with this final rule (i.e., minimum age discretion to deem products only on a
comment, and the word ‘‘Response,’’ in and identification requirements, product-by-product basis, or at best, a
parentheses, will appear before each vending machine restrictions, and category-by-category basis, and that
response. We have numbered the health warning statements) are FDA lacks authority to ‘‘simply swallow
comments to make it easier to ‘‘appropriate for the protection of the all extant and future tobacco products
distinguish between comments; the public health.’’ up in its authority[.]’’
These authorities are supplemented (Response) FDA disagrees. Section
numbers are for organizational purposes
by section 903 of the FD&C Act (21 901 grants FDA the authority to deem
only and do not reflect the order in
U.S.C. 387c), which provides, among ‘‘any . . . tobacco products that the
which we received the comments or any Secretary by regulation deems to be
value associated with them. We have other things, that a tobacco product is
misbranded unless the manufacturer, subject to [chapter IX of the FD&C Act].’’
combined similar comments under one There is no provision in the statute that
numbered comment. In addition to the packer, or distributor thereof includes in
all advertisements and other descriptive restricts FDA’s authority to deem all
comments specific to this rulemaking tobacco products that meet the statutory
that we address in the following printed matter issued or caused to be
issued by the manufacturer, packer, or definition or requires FDA to deem
paragraphs, we received many general products on an individual or product
comments expressing support or distributor with respect to that tobacco
product a brief statement of the uses of category basis.
opposition to the rule and separate The comment did not provide a basis
provisions within the rule. These the tobacco product and relevant
for the claim that Congress intended to
comments express broad policy views warnings, precautions, side effects, and
restrict FDA’s deeming authority to
contraindications (section 903(a)(8)(B)(i)
and do not address specific points piecemeal deeming of specific

related to this rulemaking. Therefore, 5 Section 201(rr) of the FD&C Act defines categories of products and no such
these general comments do not require ‘‘tobacco product,’’ in relevant part, as any product restrictions exist. FDA believes that
a response. Other comments outside the made or derived from tobacco that is intended for deeming tobacco products on a product
scope of this rulemaking also have not human consumption, including any component, or category basis would create
been addressed here. The remaining part, or accessory of a tobacco product (except for
raw materials other than tobacco used in
regulatory loopholes, substantial delay
comments, as well as FDA’s responses, manufacturing a component, part, or accessory of a (at the risk to public health), and
are included in this document. tobacco product). 21 U.S.C. 321(rr). significantly impede FDA’s ability to
create a comprehensive regulatory (which have all been made or derived section 906(d) of the FD&C Act applies
scheme. from tobacco). This experience has to the act of deeming tobacco products.
Even if there was ambiguity in the shown us that it would be easier for Sections 901 and 906(d)(1) provide FDA
wording of section 901, which FDA manufacturers and more protective for with separate authorities. Section 901
does not believe there is, FDA would be public health for a company to know gives FDA the authority to deem
entitled to deference on this (prior to development and marketing) additional products to be subject to
interpretation of the statute (Chevron that its product must be reviewed and chapter IX. Once products are subject to
U.S.A., Inc. v. Natural Res. Def. Council, authorized by FDA in order to be offered chapter IX, FDA can use other
Inc., 467 U.S. 837, 842–45 (1984), for sale in the United States. authorities in chapter IX, such as
quoting Morton v. Ruiz, 415 U.S. 199, (Comment 3) A number of comments section 906(d), to take regulatory action
231 (1974) (‘‘We have long recognized contended that section 901(g) of the with respect to such products. By its
that considerable weight should be FD&C Act requires FDA to consult with own language, section 906(d) applies to
accorded to an executive department’s other Federal Agencies before regulations FDA issues requiring
construction of a statutory scheme it is promulgating a new rule under chapter restrictions on the sale and distribution,
entrusted to administer, and the IX of the FD&C Act. including restrictions on the access to,
principle of deference to administrative (Response) FDA agrees that section and the advertising and promotion of, a
interpretations . . .’’)). 901(g) requires FDA to ‘‘endeavor to tobacco product; therefore, the standard
(Comment 2) At least one comment consult with other Federal Agencies, as in section 906(d)(1) applies only to the
questioned whether section 901 of the appropriate.’’ FDA consulted with other additional regulations issued by FDA
FD&C Act provides authority to deem Federal Agencies during the Federal under section 906(d) (such as the
future tobacco products under the new Agency review process required by minimum age and identification
rule. Specifically, the comment argued Executive Order 12866, satisfying its requirements and vending machine
that a ‘‘tobacco product’’ must exist at requirement under section 901(g). restrictions this rule is promulgating in
the time the rule takes effect for it to be § 1140.14, and the health warning
2. FDA’s Exercise of Authority
subject to ‘‘deeming’’ under the rule. requirements in §§ 1143.3 and 1143.5)
(Response) FDA disagrees. The term (Comment 4) Some comments, largely and not to deeming itself or the
‘‘tobacco product’’ is defined in section from the ENDS industry, argued that provisions in the statute that apply
201(rr) of the FD&C Act, 21 U.S.C. FDA is required to establish that automatically to newly deemed
321(rr), to mean ‘‘any product made or deeming will benefit public health, and products.
derived from tobacco that is intended that insufficient evidence exists to do Although FDA is not required to meet
for human consumption, including any so. Specifically, they argued that FDA is a particular public health standard to
component, part, or accessory of a unable to quantify the health risks of deem tobacco products, regulation of
tobacco product (except for raw certain products (namely, e-cigarettes) 6 the newly deemed products will be
materials other than tobacco used in without multiple long-term studies, and beneficial to public health. The Agency
manufacturing a component, part, or that currently such studies do not exist. has concluded, based on scientific data,
accessory of a tobacco product),’’ and A few comments cited the public health that the newly deemed products should
excluding drugs, devices, and standard in section 906(d) of the FD&C be regulated due to their potential for
combination products as defined under Act as authority for these claims. public harm (e.g., 79 FR at 23154–
the FD&C Act. The definition has no (Response) FDA disagrees. These 23158) and regulation is necessary to
temporal element, and nothing in the comments attempted to impose a learn more about that potential. Greater
statute limits FDA’s deeming authority standard for the application of FDA’s regulatory certainty created by
to products or categories of products deeming authority that is not created by premarket authorizations should help
that are currently marketed. Contrary to statute or otherwise. Under section companies to invest in creating novel
Congress’s intention in enacting the 901(b), chapter IX of the FD&C Act shall products, with greater confidence that
statute, the proposed interpretation apply to all cigarettes, cigarette tobacco, improved products will enter the market
would substantially impede FDA’s roll-your-own tobacco, and smokeless without having to compete against
ability to protect the public health. tobacco and to any other tobacco equally novel, but more dangerous
Indeed, FDA’s ability to regulate new products that the Secretary by products. For example, a company
products would be further delayed by regulation deems to be subject to this wishing to invest the additional
months or even years after the chapter (emphasis added). The only resources needed to ensure that its e-
introduction of each new product, as the pertinent limitations on the scope of cigarette is designed and manufactured
Agency would have to initiate a FDA’s deeming authority are the with appropriate methods and controls
rulemaking to deem each new product definition of ‘‘tobacco product’’ set forth will be more likely to do so if the
before existing regulations would apply. in section 201(rr) of the FD&C Act and product is not competing against
Such an interpretation would frustrate a provision regarding tobacco growers products that are more cheaply and
the intent underlying the Tobacco and similar entities and tobacco leaf that crudely made, yet appear to be identical
Control Act and endanger the public is not in the possession of a to the consumer. Over time, since the
health. manufacturer of tobacco products in ‘‘appropriate for the protection of the
Moreover, we note that the Agency is section 901(c)(2) of the FD&C Act. public health’’ standard involves
not simply creating a rule to apply to FDA disagrees with the comments comparison to the general tobacco
theoretical products with completely that argued that the standard set forth in product market, FDA believes the
unknown risks that will be developed in employment of the premarket

6 FDA notes that most comments referred to ‘‘e-
the future. Instead, FDA is finalizing authorities could create incentives for
cigarettes’’ when discussing ENDS products.
this rule to include all ‘‘tobacco Therefore, FDA refers to ‘‘e-cigarette’’ in the producers to develop products that are
products’’ within the scope of its comment summaries. Because FDA’s responses less dangerous when consumed, less
regulatory authority based on the generally apply to all ENDS products (the most likely to lead to initiation of tobacco
popular of which are electronic cigarettes, but also
potential harm posed by existing includes e-hookah, e-cigars, vape pens, personal use, and/or easier to quit.
products and the Agency’s experience vaporizers, and electronic pipes), FDA’s responses Further, FDA’s premarket review of
with the regulation of such products to the comments generally use the term ‘‘ENDS.’’ the newly deemed products will
increase product consistency. For benefit on or harm to public health at Tobacco Control Act authorizes FDA to
example, FDA’s oversight of the the population level—and there have impose certain types of restrictions that
constituents of e-cigarettes cartridges not yet been long-term studies it has determined are appropriate to the
will help to ensure quality control conducted to support either claim at protection of public health. Under this
relative to the chemicals and their this time—regulation of ENDS will still authority, FDA is imposing certain
quantities being aerosolized and benefit public health. The 2014 Surgeon restrictions for ENDS and other
inhaled. At present, there is significant General’s Report also notes that products, such as minimum age
variability in the concentration of ‘‘[f]urther research with attention to requirements.
chemicals amongst products—including their individual and population-level The need for deeming is further
variability between labeled content and consequences will be helpful to fully confirmed by the continued dramatic
concentration and actual content and address these questions. However, the rise in youth and young adult use of
concentration (e.g., Refs. 16, 17, 18, 19, promotion of noncombustible products tobacco products such as e-cigarettes
20). Without a regulatory framework, is much more likely to provide public and waterpipe tobacco, and continued
users who expect consistency in these health benefits only in an environment youth and young adult use of cigars
products may instead be subject to where the appeal, accessibility, (mainly cigarillos). As discussed in the
significant variability in nicotine promotion, and use of cigarettes and NPRM, e-cigarettes are widely available
content among products, raising other combusted tobacco products are in retail outlets such as kiosks in
potential public health and safety being rapidly reduced’’ (Ref. 9 at 874). shopping malls and on the Internet and
issues. Implementation of the premarket FDA noted in the NPRM that many their online popularity has surpassed
review requirements also will allow public health benefits will flow from that of snus which has been on the
FDA to monitor product development deeming tobacco products (including e- market far longer than e-cigarettes (Ref.
and changes and to prevent more cigarettes and other ENDS). Even if a 21).
harmful or addictive products from category of products were to prove Recent studies show a dramatic rise in
reaching the market. generally beneficial, individual the use of ENDS products. The Centers
In addition, as FDA discussed in the
products within that category may raise for Disease Control and Prevention
NPRM, deeming all tobacco products
concerns. For example, some products (CDC) and FDA analyzed data from the
will provide FDA with critical
may be particularly attractive to youth 2011–2014 National Youth Tobacco
information regarding the health risks of
or deliver unexpected high levels of Surveys (NYTS) and found that current
the products including information
derived from ingredient listing toxicants. In addition, once all tobacco (past 30 day) e-cigarette use among high
submissions and reporting of HPHCs products are deemed, any manufacturer school students increased nearly 800
required under the FD&C Act (79 FR seeking to market its product as a percent from 1.5 percent in 2011 to 13.4
23142 at 23148). Obtaining this modified risk tobacco product (MRTP) percent in 2014 (Ref. 22). In 2014, a total
information is particularly important will be required to provide of 24.6 percent of high school students
given the addictiveness of nicotine and substantiation and obtain an order from reported current use of a tobacco
the toxicity associated with tobacco FDA before making such claims, where product (id.). Among all high school
products. Given that ‘‘[e]xposure to it is currently not subject to such students, e-cigarettes (13.4 percent)
secondhand tobacco smoke has been requirements under the FD&C Act. More were the most common tobacco
causally linked to cancer, respiratory, generally, regulation and product products used (id.). This increase was
and cardiovascular diseases, and to review allows the Agency to help ensure not limited to any one demographic
adverse effects on the health of infants the public health is protected. FDA’s group; e-cigarettes were the most
and children,’’ this information will be regulatory tools, including the commonly used product among high
helpful in further assessing the toxicity adulteration and misbranding school non-Hispanic whites, Hispanics,
of the newly deemed tobacco products provisions in sections 902 (21 U.S.C. and persons of non-Hispanic other races
(Ref. 9 at 7).7 387b) and 903 of the FD&C Act as (id.). E-cigarettes (3.9 percent) were also
Many of these comments also argued applied to newly deemed products, will the tobacco product used most
that FDA’s acknowledgment that it does help to protect consumers by subjecting commonly by middle school students
‘‘not currently have sufficient data . . . all tobacco products to certain basic (id.). From 2011 to 2014, statistically
to determine what effects e-cigarettes requirements, such as that their labeling significant nonlinear increases were
have on the public health’’ is an and advertising not be false or observed among high school students
admission that FDA does not know, and misleading. FDA will be able to take for current e-cigarette use (1.5 percent to
cannot determine, whether regulation of enforcement action against any tobacco 13.4 percent) (id.). Among middle
these products will benefit public products that do not meet these school students, statistically significant
health. FDA disagrees. That language requirements. Further, implementation increases were observed from 2011 to
follows the statement, ‘‘some have of the requirements regarding premarket 2014 (id.). In 2014, an estimated 4.6
advanced views that certain new applications, SE reports, and exemption million middle and high school
tobacco products that are requests (sections 905 and 910 of the students currently used any tobacco
noncombustible . . . may be less FD&C Act (21 U.S.C. 387e and 387j, product (i.e., cigarettes, cigars,
hazardous, at least in certain respects, respectively)) will increase product smokeless tobacco, e-cigarettes,
than combustible products . . . ,’’ and consistency and help protect the public hookahs, tobacco pipes, snus,
refers to the lack of evidence supporting health from adverse impacts. For dissolvable tobacco, and bidis), of
such asserted benefits (79 FR 23142 at example, although there is currently which an estimated 2.2 million students
23144). Whether ENDS generally may variability in the concentrations of currently used two or more tobacco
eventually be shown to have a net chemicals in e-liquids, FDA oversight of products. Overall, in 2014, 2.4 million
the constituents in e-liquids and ENDS middle and high school students
7 As stated in the 2014 Surgeon General’s Report,
will help to ensure quality control over reported current use of e-cigarettes (id.).
‘‘the burden of death and disease from tobacco use the types and quantities of chemicals The data also demonstrated that when
in the United States is overwhelmingly caused by
cigarettes and other combusted tobacco products’’ being aerosolized and inhaled (79 FR use of all tobacco products was
(Ref. 9 at 7). 23142 at 23149). Once deemed, the considered in aggregate, there was no
change in overall current tobacco use middle school students from 1.1 percent 401 U.S. 402, 416 (1971); Motor Vehicle
among middle and high school students. (120,000) to 2.5 percent (280,000) (id.). Mfrs. Ass’n of U.S., Inc. v. State Farm
Another recently published study These findings are consistent with Mut. Auto. Ins. Co., 463 U.S. 29, 42–43
found that ninth grade students who earlier research on older youths and (1983).
reported having ever used e-cigarettes at young adults discussed in the comments In any event, the NPRM contains
the baseline assessment were stating that waterpipe tobacco use substantial explanation of FDA’s
approximately 2.7 times more likely continues to increase in popularity, reasoning in proposing this rule,
than non-e-cigarette users to have particularly among college students, including over 190 citations to scientific
started smoking combusted tobacco with as many as 40 percent reporting literature, and the NPRM and the final
products (cigarettes, cigars, waterpipe ever using waterpipe tobacco and 20 rule’s supplementary information
tobacco) and 1.7 times more likely to percent reporting current use (i.e., use contain many pages explaining the data
have started smoking conventional within the past 30 days) on some college and comments considered, the
cigarettes 6 to 12 months later (Ref. 23). campuses (Refs. 25, 26). conclusions drawn from the literature,
While this study indicates that e- Likewise, youth continue to use and FDA’s rationale for the final rule,
cigarette users are more likely than non- cigars. Data from the 2014 NYTS fully satisfying the Administrative
e-cigarette users to also use combusted indicate that 8.2 percent (1,200,000) of Procedure Act (APA).
tobacco products 12 months later, it high school students and 1.9 percent (Comment 6) A few comments
cannot be determined by the research (220,000) of middle school students had objected that FDA did not discuss the
findings if such users would have used smoked cigars (including cigars, possibility of illicit markets in the
combusted tobacco products regardless cigarillos, or little cigars) in the past 30 proposed deeming rule, stating that FDA
of e-cigarette use. Researchers noted that days (Ref. 22). Nineteen percent of is required to consider the consequences
some teens are more likely to use e- students in 8th, 10th, and 12th grades of illicit markets under section 907(b)(2)
cigarettes prior to combustible tobacco participating in the Monitoring the of the FD&C Act.
products for several reasons including Future study in 2014 also reported (Response) FDA disagrees. Section
the availability of e-cigarettes in flavors smoking small or little cigars (which 907(b)(2) does not apply to deeming, but
attractive to youth (id.). represents a decrease from 23.1 percent rather applies only to the promulgation
In terms of young adult and adult use in 2010, but it is unclear if subjects of regulations establishing tobacco
of e-cigarettes, evidence from the most misidentified cigars as cigarettes during product standards under section 907 of
recent studies on ENDS use among the study) (Ref. 27). In addition, the the FD&C Act. In any event, the Agency
young adults and adults indicates that 2014 National Survey on Drug Use and cannot refuse to act in furtherance of the
among adults who had never smoked Health (NSDUH) found that more than public health because some individuals
cigarettes, prevalence of ever e-cigarette 2,500 youth under the age of 18 smoke might violate the law. Nevertheless,
use was highest among young adults their first cigar each day, nearly as many FDA authority over the newly deemed
aged 18 to 24 and decreased with as those who smoke their first cigarette tobacco products will give it means to
increasing age (Ref. 24). However, each day (more than 2,600) (Ref. 28). determine which products are legally on
current cigarette smokers and recent Nevertheless, data on youth cigar use the market and which are counterfeit or
former smokers (i.e., those who quit from the Youth Risk Behavior otherwise illegally marketed and to take
smoking within the past year) were Surveillance System (YRBSS) shows enforcement action against
more likely to use e-cigarettes than long- that current cigar use among youth (i.e., manufacturers who sell and distribute
term former smokers (i.e., those who use of a cigar, cigarillo, or little cigar on illegal products. The Tobacco Control
quit smoking more than 1 year ago) and at least one day during the last 30 days) Act gives the Agency these and other
adults who had never smoked. Current has declined between 1997 and 2013 (22 authorities, such as section 920 of the
cigarette smokers who had tried to quit percent to 12.6 percent); however, no FD&C Act (21 U.S.C. 387t), to help
in the past year were also more likely to statistically significant change was address illicit tobacco products.
use e-cigarettes than those who had not observed between 2011 (13.1 percent)
tried to quit (id.). It is noted that it and 2013 (12.6 percent) (Ref. 29). 3. Constitutional Issues
cannot be determined by the research (Comment 5) At least one comment The Tobacco Control Act includes
findings: (1) Whether former cigarette argued that the rule violates the APA, 5 provisions restricting tobacco product
smokers who now exclusively use e- U.S.C. 706, saying that it requires FDA marketing. As discussed in this
cigarettes would not have ceased to provide ‘‘the specific basis for [its] document, some of these provisions
smoking cigarettes regardless of e- conclusion and the data on which each apply to all products covered by the
cigarette use; and (2) whether the e- of [its] critical assumptions is based’’ statute—including the newly deemed
cigarette use preceded quitting or the (quoting Ranchers Cattlemen Action products—and others authorize FDA to
quitting occurred first and then was Legal Fund United Stockgrowers of impose additional restrictions. We
followed by later e-cigarette use. America, No. 04–cv–51, 2004 WL received comments that argue that some
The data from the 2011 through 2014 1047837 at *7 (D. Mont. Apr. 26, 2004), of the restrictions this final rule imposes
NYTS also show that high school and FDA failed to do so. on newly deemed products violate the
students’ use of waterpipe tobacco more (Response) FDA disagrees. The First Amendment.
than doubled during this time period. In unpublished district court case quoted
fact, researchers observed substantial in the comment was reversed by the a. Free Samples of Tobacco Products
increases in waterpipe tobacco use Ninth Circuit on exactly this point (415 (Comment 7) A few comments
among both middle and high school F.3d 1078 (9th Cir. 2005)). The Ninth questioned the constitutionality of the
students from 2011 through 2014 Circuit stated the correct standard: ‘‘All ban on the distribution of free samples
culminating in an estimated 1.6 million that is required is that the agency have of tobacco products. (See
waterpipe tobacco youth users in 2014 ‘considered the relevant facts and § 1140.16(d)(1)).) First, the comments
(Ref. 22). From 2013 to 2014, prevalence articulated a rational connection argued that distributing free samples is
almost doubled for high school students between the facts found and the choices a form of commercial speech that is
from 5.2 percent (770,000) to 9.4 percent made’ ’’ (id. at 1093). See Citizens to protected by the First Amendment and
(1.3 million) and more than doubled for Preserve Overton Park, Inc. v. Volpe, that the ban is unconstitutional as
applied to the newly deemed products. interest of decreasing use of tobacco which appear to be youth-oriented (Ref.
Citing Central Hudson Gas and Electric products by youth. The manufacturers 31).
Corp. v. Public Services Commission, further argued that even if the sampling • In 2012 and 2013 alone, 6 e-
447 U.S. 557, 566 (1980), the comments ban were effective, there are less cigarette companies sponsored or
argued that, accordingly, FDA must restrictive methods of preventing youth provided free samples at 348 events,
show that the ban is narrowly tailored tobacco use (id. at 538, 541). The Sixth many of which were music festivals and
to directly and materially advance a Circuit rejected both arguments, and motorsport events geared toward young
substantial State interest and that FDA held that the government ‘‘presented people—including Grand Prix auto
failed to do so. The comments stated extensive documentation that free racing events (id.).
that while the court in Discount samples of tobacco products are [an] • Field research in Oregon found that
Tobacco City & Lottery v. United States, ‘easily accessible source of these e-cigarette retailers include the
674 F.3d 509 (6th Cir. 2012), cert. products to young people,’ . . . and opportunity to sample the wide variety
denied sub nom. Am. Snuff Co., LLC v. freely obtainable, even with the tobacco of flavored nicotine cartridges in their
United States, 133 S. Ct. 1996 (2013) industry’s ‘voluntary codes that sales pitches with test stations for free
(‘‘Discount Tobacco’’), upheld the supposedly restrict distribution of free sampling (Comments of Oregon Health
Tobacco Control Act’s sampling ban on samples to underage persons’’’ id. at 541 Authority, FDA–2014–N–0189–76358).
cigarettes, the evidence the court used (quoting 61 FR 44396 at 44460, 45244– As described above and in the NPRM,
to uphold that ban does not support the 45 & nn. 1206–08 (August 28, 1996)). the free sample provision will address
same ban for the newly deemed tobacco The Court further held that free samples distribution of newly deemed tobacco
products. They argued that FDA has ‘‘may serve as the best advertisement of products at venues such as these.
presented no evidence that samples of all for a product that is physiologically Contrary to the assertions in the
these products lead to youth initiation addictive, and socially attractive to comments, FDA does not believe that it
and, therefore, the Agency would not be youth’’ (id.). could achieve the same results by
advancing a legitimate government The comments do not attempt to allowing samples of newly deemed
interest with this ban. Additionally, distinguish Discount Tobacco. Here, products in qualified adult-only
they suggested that even if the ban did where there is a substantial government facilities, as FDA does with smokeless
advance a legitimate government interest in preventing youth access to all tobacco. In section 102(a)(2)(G) of the
interest, FDA could achieve the same tobacco products, and the newly Tobacco Control Act (21 U.S.C. 387a–
results through less restrictive means, deemed products, like the products 1(a)(2)(G)), Congress required FDA to
such as by allowing samples in qualified considered by the Sixth Circuit Court of reissue the final 1996 rule (published in
adult-only facilities, as FDA does with Appeals, are also ‘‘physiologically the Federal Register of August 28, 1996,
smokeless tobacco. addictive, and socially attractive to 61 FR 44396), with several changes,
(Response) FDA disagrees that the ban youth,’’ Discount Tobacco is directly on including the addition of a narrow
on free samples is unconstitutional. point. As we stated in the NPRM, the exception to the free sample ban to
First, although FDA acknowledges that prohibition against free samples will allow for distribution of smokeless
in Discount Tobacco, 674 F.3d at 538– eliminate a pathway for youth to access tobacco products in qualified, adult-
39, the Sixth Circuit treated the tobacco products, which can help in only facilities (QAOFs). This exception
distribution of free samples as a form of reducing youth initiation and therefore is very prescriptive and operates only in
commercial speech, FDA continues to short-term and long-term morbidity and very limited instances (e.g., where the
believe that distribution of free samples mortality resulting from these products. product is distributed in a specific type
is conduct not speech. Provisions that Youth are uniquely susceptible to of temporary enclosed structure with
regulate conduct without a significant biological, social, and environmental age verification by a law enforcement
expressive element do not implicate the influences to use and become addicted officer or a security guard licensed by a
First Amendment. See Arcara v. Cloud to tobacco products. See section X.A. As governmental entity, and with the
Books, Inc., 478 U.S. 697, 706–07 FDA recognized as early as 1995, ‘‘[f]ree amount of smokeless tobacco per adult
(1986). Additionally, a free sample ban samples give young people a ‘risk-free consumer subject to specific portion
is akin to a price restriction (i.e., tobacco and cost-free way to satisfy their requirements). If FDA were to extend
products cannot be free)—a ‘‘form[ ] of curiosity’ about tobacco products, and, this exception, in whole or in part, to
regulation that would not involve any when distributed at cultural or social other tobacco products (when Congress
restriction on speech.’’ 44 Liquormart, events, may increase social pressure on explicitly extended the free sample ban
Inc. v. Rhode Island, 517 U.S. 484, 507 young people to accept and to use the to cigarettes and all ‘‘other tobacco
(1996) (opinion of Stevens, J.). free samples’’ (60 FR 41314 at 41326 products,’’ which would include all
Therefore, the free sample provision (quoting Ref. 30). For these reasons, we future deemed tobacco products and
regulates the distribution of a product, believe it is critical to prohibit the laid out the qualified adult-only facility
and there is no First Amendment right distribution of free samples of newly exception only for smokeless), FDA
to distribute free samples of a tobacco deemed tobacco products, which are would have to justify such an exception
product. highly addictive and can lead to a in light of the potential adverse public
Second, even if the distribution of free lifetime of tobacco use, with attendant health impact of allowing free samples
samples does implicate the First adverse health consequences. and determine the particular parameters
Amendment, as the Sixth Circuit FDA received comments noting of the exception as appropriate for
concluded, the court went on to uphold extensive sampling of some newly newly deemed tobacco products. This
the constitutionality of the restriction on deemed products in venues that may would include, at a minimum,
free samples of tobacco products. attract youth, including: parameters relating to type of facility,
Discount Tobacco, 674 F.3d at 541. In • The major sellers of e-cigarettes means of access, type(s) of tobacco
Discount Tobacco, as here, the distribute free samples in venues likely products distributed, and portion sizes
manufacturers of tobacco products to attract large audiences. for each type of tobacco product for
argued that the government failed to • At least eight e-cigarette companies which FDA is creating an exception.
show that the ban would directly and promote their products through Newly deemed products have been
materially advance the government sponsored or sampling events, many of largely unregulated and their markets,
particularly for novel noncombustible (2013)). With the growth in the use of products (id.). That restriction on
products such as ENDS, are dynamic. ENDS, particularly by youth (see section commercial speech, the court held, is
Comments did not provide evidence VIII.B), a free sample prohibition is constitutional under Central Hudson
demonstrating that the distribution of necessary to reduce youth access to Gas & Electric Corp. v. Public Service
free samples of newly deemed tobacco ENDS and possibly a transition to Commission, 447 U.S. 557 (1980): It
products would be consistent with combusted tobacco products (see Ref. advances a substantial government
protecting public health. While there is 23). interest in preventing inaccurate and
evidence suggesting that distribution of harmful health claims about tobacco
b. Modified Risk Tobacco Products
tobacco products is harmful (e.g., courts products of the sort that the industry
have expressed concern that free Section 911 of the FD&C Act (21 has made for many decades, and it is
samples can provide young people with U.S.C. 387k) prohibits the introduction sufficiently tailored because it concerns
easy access to tobacco products), FDA or delivery for introduction into only consumer-targeted speech about
has not yet obtained product-specific interstate commerce of any MRTP tobacco products’ health effects or
evidence and, therefore, cannot set without an FDA order in effect under contents and is no more extensive than
limits for the quantities or portion sizes section 911(g). An MRTP is a tobacco warranted. Discount Tobacco, 674 F.3d
of products taken away from a QAOF product that is sold or distributed for at 534–37. FDA observes that this
that are commensurate with the current use to reduce harm or the risk of comment did not address Discount
exception for smokeless tobacco tobacco-related disease associated with Tobacco’s holding or the Sixth Circuit’s
products. Therefore, QAOFs could still commercially marketed tobacco analysis.
allow for access to tobacco products in products; this includes tobacco (Comment 10) A few comments
a manner that will have a negative products, the product label, labeling, or argued that section 911 may violate the
public health impact. advertising of which represents that it is First Amendment if it is applied to ban
Prohibiting free samples is a minor less harmful or presents a lower risk of descriptions of e-cigarettes and other
restriction on distribution, and tobacco disease than other tobacco products. noncombustible products as
product manufacturers, distributors, and (Comment 9) A comment from one ‘‘smokeless’’ or ‘‘smoke-free.’’
retailers remain free to inform tobacco company argued that section (Response) FDA has carefully
consumers about their products. The 911 is unconstitutional on its face. This considered the comments that argued
free sample prohibition does not comment argued, at length, that FDA’s that noncombusted products, including
interfere with the ability of a oversight of claims that a particular ENDS, should be permitted to use the
manufacturer, distributor or retailer to tobacco product is safer than others terms ‘‘smokeless’’ and smoke-free’’ to
communicate truthful and violates the First Amendment—even as describe their products. We note that
nonmisleading information to adult applied to currently regulated products, section 911 provides that ‘‘No smokeless
consumers. We further address this such as cigarettes. tobacco product shall be considered to
prohibition and respond to additional (Response) Comments addressed to be [an MRTP] solely because its label,
comments in section XI.F. the facial constitutionality of a statute labeling, or advertising uses the
(Comment 8) Some comments are generally outside the scope of an following phrases to describe such
recommended that FDA exempt e- agency’s rulemaking authority. Am. product and its use: ‘smokeless tobacco,’
cigarettes from the prohibition on free Meat Inst. v. U.S. Dep’t of Agric., 760 ‘smokeless tobacco product,’ ‘not
samples. In the alternative, the F.3d 18, 25 (D.C. Cir. 2014) (en banc) consumed by smoking,’ ‘does not
comments recommended that FDA (‘‘We do not think the constitutionality produce smoke,’ ‘smokefree’ [and four
restrict the circumstances in which free of a statute should bobble up and down more similar terms].’’ However, this
samples may be given to adult at an administration’s discretion.’’). provision only applies to ‘‘smokeless
consumers. For example, comments That said, FDA disagrees with the tobacco,’’ which is explicitly defined in
suggested that FDA require age challenges against section 911’s the FD&C Act as ‘‘any tobacco product
verification for each recipient of a free constitutionality. The Sixth Circuit that consists of cut, ground, powdered,
sample and limit the amount of free considered and unanimously rejected or leaf tobacco and that is intended to
products that recipients may take away the same argument in Discount be placed in the oral or nasal cavity’’
from an event in which samples are Tobacco, 674 F.3d at 531–37, and the (section 900(18) of the FD&C Act). ENDS
distributed. Supreme Court denied the do not fall within that definition.
(Response) We disagree for the manufacturers’ petition for a writ of Moreover, in contrast to ENDS,
reasons discussed in the response to the certiorari (133 S. Ct. 1966 (2013)). As consumption of ‘‘smokeless tobacco
previous comment. As stated in the the Sixth Circuit explained, section 911 products,’’ as defined, does not require
NPRM, prohibiting free samples requires that a manufacturer establish the use of heat, inhalation of the
eliminates a pathway to tobacco health claims for particular tobacco product into the lungs, or exhalation of
products for youth, which can help to products to FDA before marketing, constituents into the close environment.
reduce initiation and thus decrease rather than allow only post-market FDA is also aware that some e-cigarettes
morbidity caused by use of tobacco review of such claims (674 F.3d at 537 are heated to a high enough level to
products (79 FR 23142 at 23149). In (‘‘it would be a virtual impossibility to cause combustion of the e-liquid. For
addition, the United States Court of unring the bell of misinformation after these reasons, and until FDA obtains
Appeals for the Sixth Circuit previously it has been rung’’)). This provision does product-specific evidence, the Agency
recognized that FDA has provided not ‘‘infringe significantly on will evaluate an ENDS manufacturer’s
‘‘extensive’’ evidence that free tobacco noncommercial speech’’ since it leaves use of ‘‘smokeless’’ or ‘‘smoke-free’’
samples constitute an ‘‘easily accessible ‘‘untouched’’ manufacturers’ ‘‘ability to (and similar descriptive terms) on a
source’’ for youth (Discount Tobacco make ‘direct comments on public case-by-case basis, and the Agency will
City & Lottery, Inc. v. United States, 674 issues’ ’’ (id. at 533 (citation omitted)). continue to apply the MRTP provisions
F.3d 509, 541 (6th Cir. 2012) (citing 61 Instead, the court held, what section 911 in a manner consistent with the statute
FR 44396 at 44460, August 28, 1996), restricts is commercial speech, since it and Constitution. This case-by-case
cert. denied sub nom. Am. Snuff Co., applies to consumer-directed claims approach to ‘‘smokeless,’’ ‘‘smoke-free,’’
LLC v. United States, 133 S. Ct. 1966 regarding a manufacturer’s specific and similar terms is appropriate as
applied to ENDS, which encompasses a cigars, contending that cigar users do panels is unduly burdensome and
broad, heterogeneous, and evolving not always inhale. would prevent manufacturers of newly
category of products. (Response) Nicotine is ‘‘one of the deemed products from communicating
most addictive substances used by information about their products. As in
4. Required Warning Labels humans’’ (Ref. 7). ‘‘Because the Discount Tobacco, the comments failed
This final rule requires advertising extension of First Amendment to substantiate that claim with evidence.
and packaging warnings for newly protection to commercial speech is Nor did the comments provide evidence
deemed covered tobacco products and justified principally by the value to that the same size requirements for
for cigarette tobacco and roll-your-own consumers of the information such smokeless tobacco—which have been in
tobacco, as authorized by Section 906(d) speech provides,’’ the manufacturers’ force since 2010—have unduly
of the FD&C Act, 21 U.S.C. 387f (d). ‘‘constitutionally protected interest in burdened the speech of smokeless
Packaging and advertising for all newly not providing any particular factual tobacco manufacturers.
deemed products other than cigars must information in his advertising is As the court explained in Discount
display an addictiveness warning that minimal.’’ Am. Meat Inst., 760 F.3d at Tobacco, Congress required larger
states: ‘‘WARNING: This product 26 (quoting Zauderer v. Office of warnings for smokeless tobacco and
contains nicotine. Nicotine is an Disciplinary Counsel, 471 U.S. 626, 651 cigarettes in the wake of the Surgeon
addictive chemical.’’ (Subject to certain (1985)). General’s conclusion that existing
requirements, the manufacturer of a Cigar packaging and advertisements warnings were ‘‘‘given little attention or
product that does not contain nicotine are required to display one of six consideration by viewers’’’ and IOM’s
may use an alternative warning that warnings, one of which is the analysis showing that those warnings
states: ‘‘This product is made from addictiveness warning. Research ‘‘‘fail[ed] to convey relevant information
tobacco.’’) Packaging and advertising for indicates that most cigar smokers do in an effective way.’’’ Discount Tobacco,
cigars must display either the inhale some amount of smoke, even 674 F.3d at 562 (quoting Refs. 3, 7).
addictiveness warning, or one of five when they do not intend to inhale, and The comments contending that the
others specified in the rule. are not aware of doing so (Refs. 32, 33). warning label size is burdensome or
The final rule requires the warnings to Even when cigar smokers do not breathe unjustified are misplaced for the same
appear on at least 30 percent of the two smoke into their lungs, they are still reasons identified by the Discount
principal display panels of the package, subject to the addictive effects of Tobacco court. After emphasizing that
and at least 20 percent of the area of nicotine through nicotine absorption the relevant First Amendment standard
advertisements. These are the same (Refs. 32, 34). This is because cigar looks only to whether mandatory
warning sizes Congress established for smoke dissolves in saliva, allowing the warnings are reasonably related to the
smokeless tobacco in the Tobacco smoker to absorb sufficient nicotine to government’s interest, Discount
Control Act: At least 30 percent of create dependence, even if the smoke is Tobacco, 674 F.3d at 567 (citing
smokeless-tobacco packaging’s two not inhaled (Refs. 34, 35). Zauderer v. Office of Disciplinary
principal panels, and at least 20 percent (Comment 12) A few comments Counsel, 471 U.S. 626, 651 (1985)), the
of the area of each advertisement. 15 argued that the First Amendment Sixth Circuit held that the required
U.S.C. 4402(a)(2)(A), (b)(2)(B). In the prohibits a requirement for covered cigarette warning labels, which were to
same Act, Congress prescribed an even tobacco products to carry warning labels cover 50 percent of the two primary
larger size for cigarette warnings: 50 that cover 30 percent of the two panels of cigarette packs (far more than
percent of the front and rear panels of principal display panels of the the 30 percent required here), did not
cigarette packaging (and the same 20 packaging. These comments argued that violate the First Amendment because
percent size for cigarette manufacturers have limited space on ‘‘[a]mple evidence supports the size
advertisements) (15 U.S.C. 1333(a)(2), packaging to communicate information requirement for the new warnings . . .
(b)(2)). (The larger warning sizes to consumers, including branding and and Plaintiffs have not shown that the
required for cigarettes have not yet been marketing information, and that remaining portions of their packaging
implemented, because FDA’s initial requiring manufacturers to dedicate 30 are insufficient for them to market their
regulations implementing a graphics percent of that space for a warning is products.’’ (674 F.3d at 567; see also id.
component for cigarette warnings were unduly burdensome, because it prevents at 530–31 (Clay, J., concurring in result)
vacated by the DC Circuit Court of manufacturers from using that space to (finding that the government
Appeals in R.J. Reynolds Tobacco Co. v. convey their own messages. The demonstrated that the Tobacco Control
FDA, 696 F.3d 1205 (D.C. Cir. 2012), comments argued that the warning label Act’s size and placement requirements
overruled on other grounds by Am. Meat presents a simple message that could be satisfied Zauderer scrutiny).)
Inst., 760 F.3d at 22–23.) relayed in a smaller space. Article 11 of the Framework
A detailed discussion of the warning (Response) FDA disagrees. In Convention on Tobacco Control (FCTC),
requirements appears in section XVI. Discount Tobacco, the Sixth Circuit evidence of a strong worldwide
considered and rejected the same First consensus regarding a regulatory
a. First Amendment Challenges Amendment arguments against the size strategy for addressing the serious
The required warnings are a form of required by the Tobacco Control Act for negative impacts of tobacco products,8
compelled disclosure, and are thus cigarette and smokeless tobacco
recognized the importance of having
subject to First Amendment scrutiny. warnings. Discount Tobacco, 674 F.3d
warnings cover at least 30 percent of the
Milavetz, Gallop & Milavetz, P.A. v. at 567. The court found ample evidence
area of the two principal display panels.
United States, 559 U.S. 229, 249 (2010); supporting the size requirements, and
The European Union (EU) requires that
Riley v. Nat’l Fed’n of the Blind of N.C., held that the manufacturers failed to
health warnings comprise 30 percent of
Inc., 487 U.S. 781, 797–98 (1988). show ‘‘that the remaining portions of
the area on the front of the package and
(Comment 11) Although the their packaging [were] insufficient for
40 percent on the back of the package
comments generally did not dispute the them to market their products’’ (id. at
need for warning labels, some 564–66, 567). The comments argued that 8 There are 180 parties to the WHO’s FCTC as of
commenters questioned the accuracy of the requirement that the warning cover November 2015. At this time, the United States is
the addictiveness warning as applied to 30 percent of the two principal display a signatory but has not ratified this treaty.
(2001/37/EC). Users are more likely to and child-resistant packaging for certain addition to, any requirement under
recall warnings that are in a larger size tobacco products. If FDA determines chapter IX of the FD&C Act relating to
and that appear on the front/major that it is appropriate for the protection tobacco product standards, premarket
surfaces of the tobacco product package. of the public health to require such a review, adulteration, misbranding,
(Ref. 7). Before a warning label can help warning (in addition to the addiction labeling, registration, good
a consumer better understand and warning), FDA will consider at that time manufacturing practices, or MRTPs.9
appreciate the risks against which it whether it is necessary to change the However, section 916(a)(2)(B) of the
warns, the consumer must notice and formatting requirements for the FD&C Act states that the express
pay attention to the warning. The addiction warning to ensure that all preemption provision in section
likelihood that a consumer will do so warnings are clear and conspicuous. 916(a)(2)(A) does not apply to
depends upon warning’s size and requirements relating to, among other
b. Preemption of State Law Warning
position. (Refs. 36, 37, 38, 39, 40). things, the sale, distribution, possession,
Some comments sought to support Requirements
information reporting to the State,
their First Amendment arguments (Comment 13) A number of comments exposure to, access to, the advertising
against the warning label sizes by citing sought an affirmative statement from and promotion of, or use of, tobacco
the D.C. Circuit’s decision in R.J. FDA that the NPRM preempts State and products by individuals of any age. A
Reynolds v. FDA, 696 F.3d 1205 (D.C. local warning requirements. A few of State or local statute is facially
Cir. 2012), which vacated specific the comments directly referenced preempted only if no set of
cigarette warnings previously issued by California’s reproductive health warning circumstances exists under which the
FDA. However, the decision in Reynolds requirements for products containing statute would be valid. (See Comm. of
was based on the graphics components nicotine (a notice mandated by Dental Amalgam Mfrs. & Distribs. v.
of the cigarette warnings, not their size. Proposition 65). Many cited the explicit Stratton, 92 F.3d 807, 810 (9th Cir.
Moreover, the reasoning of the Reynolds preemption provisions that apply to 1996).) FDA notified State and local
panel decision was overtaken by the cigarettes and smokeless tobacco (see 15 jurisdictions about the potential impact
D.C. Circuit’s more recent en banc U.S.C. 1334(b) and 4406(b)). One this rule could have on their
decision in American Meat Institute, manufacturer argued that it would be requirements. No State or local laws in
760 F.3d at 22–23. arbitrary and capricious to subject the effect at the close of the public comment
FDA recognizes that the warning size newly deemed products to a patchwork period were identified that FDA
requirement for covered tobacco of Federal, State, and municipal determined would be preempted by this
products may present special requirements, while cigarettes and final rule.
difficulties for products in particularly smokeless tobacco warning With respect to the argument that it
small packages. To address this concern, requirements are uniform across States would be arbitrary and capricious to
FDA has added subsection (d) to and potentially less stringent. The allow States and localities to subject
§ 1143.4. Under § 1143.4(d), a product comment further argued that it would be newly deemed products to different
that is too small or otherwise unable to particularly unreasonable to subject warning requirements than cigarettes
accommodate a label with sufficient noncombusted products to State and and smokeless tobacco products, we
space to bear the required warning, local labeling requirements because note that the preemptive effect depends
printed in the required font size, may (according to the comment) on the relevant statutes. The preemption
instead carry the warning on the carton noncombusted products are ‘‘safer than provisions of the Federal Cigarette
or other outer container or wrapper. In cigarettes.’’ Labeling and Advertising Act of 1965
cases where there is no carton or other Taking the other side of the issue (FCLAA) (15 U.S.C. 1334) and the
outer container or wrapper that is large were comments from public health Comprehensive Smokeless Tobacco
enough to carry the warning, the groups and a joint comment from 29 Health Education Act of 1986 (CSTHEA)
product may carry the warning on a tag State Attorneys General who advocated (15 U.S.C. 4406), which apply to
firmly and permanently affixed to the for an explicit statement that the NPRM cigarettes and smokeless products,
package. does not preempt State and local respectively, are significantly different
FDA agrees that other warnings on warning requirements, including from section 916 of the FD&C Act. For
tobacco product packages, such as a California’s Proposition 65. At a example, the FCLAA and CSTHEA
warning regarding the risk of nicotine minimum, they suggested that FDA provisions expressly preempt State and
poisoning (as suggested by one change the heading of part 1143 from local regulation of the content of
particular comment), may also provide ‘‘Required Warning Statement’’ to cigarette and smokeless product
consumers with important health risk ‘‘Minimum Required Warning advertisements, while section
information. Therefore, elsewhere in Statement’’ to indicate that the deeming 916(a)(2)(B) of the FD&C Act exempts
this issue of the Federal Register, FDA rule does not preclude other health State and local advertising restrictions
has made available draft guidance, warnings. from preemption.
which when final will describe FDA’s (Response) Section 916(a)(1) of the Separate and apart from the issue of
current thinking regarding some FD&C Act (21 U.S.C. 387p) expressly preemption, elsewhere in this issue of
appropriate means of addressing the preserves the authority of State and the Federal Register, FDA has made
premarket authorization requirements local governments to, among other available draft guidance, which when
for newly deemed ENDS products, things, enact and enforce laws regarding final will describe FDA’s current
including recommendations for tobacco products that are in addition to, thinking regarding some appropriate
exposure warnings that would help to or more stringent than, requirements means of addressing the premarket
support a showing that a product is established under chapter IX of the authorization requirements for newly
appropriate for the protection of public FD&C Act. The preservation of State and deemed ENDS products, including
health. FDA also has issued an ANPRM local governmental authority over
seeking comments, data, research, or tobacco products is limited by section 9 We note that while section 906(e) of the FD&C
other information that may inform 916(a)(2) of the FD&C Act, which Act refers to ‘‘good manufacturing practices,’’ FDA
refers to any regulations that could be issued under
regulatory actions FDA might take with expressly preempts any State or local section 906(e) as tobacco product manufacturing
respect to nicotine exposure warnings requirement that is different from, or in practices.
recommendations for exposure of compliance period. The time it takes Under section 910 of the FD&C Act,
warnings that would help support a to review a premarket application is manufacturers must receive FDA’s
showing that a product is appropriate dependent upon the type of application permission to market new, including
for the protection of public health. and the complexity of the product. FDA newly modified, tobacco products in the
Additionally, FDA notes that some has taken many steps to reduce the United States. The provision applies to
ENDS product manufacturers have previous backlog and prevent further all tobacco products covered by the
voluntarily included exposure warnings backlogs of marketing applications FD&C Act, however, those that were
on their products. Accordingly, FDA has pending FDA review. FDA intends to commercially marketed in the United
changed the heading of part 1143 from act as expeditiously as possible with States on February 15, 2007 (the
‘‘Required Warning Statements’’ to respect to all new applications, while grandfather date) do not constitute new
‘‘Minimum Required Warning ensuring that statutory standards are tobacco products and therefore do not
Statements’’ in order to clarify that part met. If an applicant wishes to discuss a require such premarket authorization.
1143 is not intended to prevent tobacco product application, the applicant may See section 910(a) of the FD&C Act
product manufacturers from including request a meeting as set forth in FDA’s (defining ‘‘new tobacco product’’ as any
truthful, non-misleading warnings on final guidance entitled ‘‘Meetings with tobacco product (including those
their products’ packaging or Industry and Investigators on the products in test markets) that was not
advertisements voluntarily or as a result Research and Development of Tobacco commercially marketed in the United
of FDA guidance. Products’’ (announced May 25, 2012, 77 States as of February 15, 2007, or has
FR 31368). been modified since that date).
III. Use of Premarket Pathways for In addition, we are clarifying that
Newly Deemed Products Products that were introduced or
FDA distinguishes between a marketing
As stated in the proposed deeming modified after the grandfather date may
application that has been ‘‘filed,’’ one
rule, manufacturers of newly deemed seek permission to market under one of
that ‘‘has been accepted,’’ and one that
products that are ‘‘new tobacco three pathways. The manufacturer may
has been ‘‘submitted’’ to FDA. A
products’’ as defined in section submit a PMTA, which is an application
marketing application has been
910(a)(1) of the FD&C Act will be that requires the manufacturer to
‘‘submitted’’ when a complete
required to obtain premarket provide information about the product,
application is delivered and received
authorization of their products through including ingredients, additives,
electronically, through the mail, or
one of three pathways—SE., exemption properties, manufacture, processing,
through a courier to CTP’s Document
from SE., or premarket tobacco product Control Center (DCC). Once a complete labeling, and health risks, among other
application (PMTAs) (sections 905 and PMTA application is submitted and things (section 910(b) of the FD&C Act).
910 of the FD&C Act). The substantive received by CTP’s DCC, FDA will have FDA will grant permission to market the
requirements of these provisions are set 180 days to consider the application as new product if the PMTA shows that it
by statute and, thus, have not changed described in section 910(c)(A) of the would be appropriate for the protection
from the NPRM. However, FDA has Tobacco Control Act. A marketing of the public health, among other things
revised the compliance periods for application ‘‘has been accepted’’ after (section 910(c)(2) of the FD&C Act; see
submitting premarket applications, as the Agency completes a preliminary also section 910(c)(4) (requiring FDA to
discussed in section V.A. review and determined that the consider the risks and benefits to both
As an initial matter, with this final application on its face contains users and nonusers, and explicitly
rule, we are also clarifying when FDA information required by the statutory requiring FDA to consider the effect of
will consider a document to have been and/or regulatory provisions applicable marketing the product on the likelihood
submitted for purposes of the to that type of application. A marketing that existing users of tobacco products
compliance periods for submission of application has been ‘‘filed’’ after the will stop using them, and the likelihood
documents and data required by the Agency completes a threshold review that nonusers of tobacco products will
automatic provisions of the statute. In and has determined that a complete, start)). Whether the marketing of a
the NPRM, we noted that the automatic substantive review is warranted. This product is appropriate for the protection
provisions require companies to submit filing review occurs only for a PMTA or of the public health will be evaluated on
information to FDA, and we proposed a modified risk application and results a case-by-case basis (in accordance with
various compliance periods to provide in either a filing letter or a refusal to file Section 910(c)(4) of the FD&C Act) and
industry with time to make such letter. with consideration of the continuum of
submissions (e.g., ‘‘the manufacturer risk of nicotine-delivering products. The
submits a 905(j) report for the product A. Background: The Three Pathways To statute instructs FDA to base its findings
by [effective date of part 1100 plus 24 Market a New Tobacco Product regarding whether marketing the
months]’’). As previously discussed We received a large number of tobacco product would be appropriate
publically (see http://www.fda.gov/ comments addressing the pathways to for the protection of public health on
tobaccoproducts/newsevents/ market a new tobacco product. well-controlled investigations, which
ucm393894.htm), FDA generally relies Comments from industry argued that the may include one or more clinical
on the date of receipt of a submission review process for a new tobacco investigations, where appropriate.
by FDA’s Document Control Center product is simply too difficult—that the However, it also allows FDA to
(DCC) as the date that the document was standard is too high, and that the authorize that its findings be made on
submitted (not the date that the burden of submitting an application is the basis of valid scientific evidence
submitter sent it). The DCC has been too great. Many manufacturers of the other than controlled studies if FDA
and will continue to be fully equipped newly deemed products argued that the finds such other evidence sufficient to
to receive tobacco product submissions two alternative pathways—SE and the evaluate the tobacco product (section
(including the number of submissions SE exemption—are not available to 910(c)(5) of the FD&C Act). We received
expected at the close of compliance them because there is no predicate to several comments addressing the
periods). Therefore, regulated entities which they can claim SE. We address burden the PMTA application places on
should ensure that FDA’s DCC receives these comments in the following manufacturers, including the expense
any submission by the due date or end sections. and time that clinical studies require.
Elsewhere in this issue of the Federal as discussed in section 905(j)(3) of the identified a non-flavored e-cigarette
Register, FDA is announcing the FD&C Act. (also marketed as an ‘‘e-cigar’’) that may
availability of a draft guidance, which have been on the market on February
B. Interpretation of Substantial
when final will provide the Agency’s 15, 2007. This product may possibly be
Equivalence
current thinking regarding some able to serve as an appropriate predicate
appropriate means of addressing the (Comment 14) Some comments for purposes of the SE pathway. The
premarket authorization requirements argued that FDA should interpret burden of demonstrating that a valid
for newly deemed ENDS products, ‘‘substantial equivalence’’ broadly so predicate exists rests with the
including specific recommendations that newly deemed products could manufacturer submitting a SE report. To
concerning how to support a showing avoid what the comments characterize facilitate the determination that a
that the marketing of a new tobacco as the more burdensome new tobacco product is eligible as a predicate for an
product is appropriate for the protection product application (PMTA) pathway SE application, any individual who has
of the public health. with a showing that the product has evidence that an e-cigarette or other
The second pathway to market is the some similar characteristics to the tobacco product was commercially
SE pathway, which allows for a predicate products. marketed in the United States on
(Response) FDA disagrees. SE is February 15, 2007, is encouraged to
manufacturer to apply for permission to
explicitly defined in section 910(a)(3) of contact the Agency at 1–877–CTP–1373.
market a tobacco product that it
the FD&C Act, which provides, in Regardless of the predicate selected for
demonstrates is ‘‘substantially
relevant part, that the term comparison, manufacturers are
equivalent’’ to a tobacco product that
‘‘substantially equivalent’’ or responsible for providing scientific data
was marketed on the grandfather date or
‘‘substantial equivalence’’ means that adequate to demonstrate that, in the
to a product previously found
the Secretary by order has found that case of an SE Report, the characteristics
substantially equivalent (the
the tobacco product: (1) Has the same
‘‘predicate’’) (section 910(a)(2)(A) and are the same or, if the characteristics are
characteristics as the predicate tobacco
section 905(j) of the FD&C Act). To different, these differences do not cause
product or (2) has different
receive marketing authorization under the new product to raise different
characteristics and the information
the SE pathway, a manufacturer must questions of public health. It should
submitted contains information,
submit an application that shows that also be noted that, where the predicate
including clinical data if deemed
the product to be marketed has the same and new products are in a different
necessary by the Secretary, that
characteristics as the predicate tobacco category or subcategory, the evidence
demonstrates that it is not appropriate
product or has different characteristics needed to obtain marketing
to require a PMTA because the product
and the information submitted contains authorization through the PMTA
does not raise different questions of
information, including clinical data if public health. Section 910(a)(3)(B) pathway may be similar to gather and
deemed necessary by the Secretary, that provides that the term ‘‘characteristics’’ submit than that needed for the SE
demonstrates that it is not appropriate means the materials, ingredients, pathway. For example, as stated in the
to regulate the product under section design, composition, heating source, or NPRM, it is possible that an applicant
910 because the product does not raise other features of a tobacco product. A may not need to conduct any new
different questions of public health product must have the same nonclinical or clinical studies for
(section 910(a)(3)(A) of the FD&C Act). characteristics—all of the same PMTA, while in other cases, such as
The statute defines ‘‘characteristics,’’ for characteristics—as the predicate where there is limited understanding of
this purpose, as the materials, product, to be found substantially a product’s potential impact,
ingredients, design, composition, equivalent under section 910(a)(3)(A)(i) nonclinical and clinical studies may be
heating source, or other features of a of the FD&C Act or if the new product required for market authorization. In
tobacco product (section 910(a)(3)(B) of has different characteristics FDA must cases where no new nonclinical or
the FD&C Act). find that the new product does not raise clinical studies are needed, the effort
As new tobacco products continue to different questions of public health associated with gathering and
evolve from the cigarettes and under section 910(a)(3)(A)(ii). submitting a PMTA may not be
smokeless tobacco that were on the FDA notes that for newly deemed materially greater than that for an SE
market on the grandfather date, the SE products about which concerns have Report.
pathway may not be available for some been raised with respect to the As stated earlier, the FD&C Act does
new products. The availability of the SE availability of an appropriate not place limitations on which pathway
pathway for the newly deemed products predicate—e.g., e-cigarettes—many of manufacturers can use to seek market
was the subject of many comments, with these products have entirely different authorization for a new product. Thus,
some arguing that a different, later characteristics from traditional tobacco manufacturers may choose to submit
grandfather date should be adopted, and products. As such, a manufacturer applications under any of the three legal
others arguing there should be no would need to satisfy section pathways. To obtain marketing
change in the grandfather date and that 910(a)(3)(A)(ii) (i.e., demonstrate that authorization under the PMTA pathway,
the newly deemed products should the new product does not raise different manufacturers are required to establish,
proceed through the PMTA pathway if questions of public health as compared among other things, that permitting
no appropriate predicate is available. to the predicate). FDA is continuing to their products to be marketed would be
Under the third pathway, a product research e-cigarettes, other ENDS, and appropriate for the protection of public
may be exempted from the SE heated cigarette products that likely health. In establishing this,
requirements if the only change to the were on the market on February 15, manufacturers should take into account,
product is a minor change and that 2007, and is working to determine the and FDA will consider, the ways in
change only involves a change to an availability of such products for which the new product is likely to be
additive in a tobacco product that can comparison. FDA determined that some used. For example, PMTAs for these
be sold under the FD&C Act, for which e-cigarettes were manufactured in 2006 products should contain information on
an SE report is not necessary and where and introduced into the United States in whether the product is likely to be used
the exemption is otherwise appropriate, early 2007. In particular, we have alone or together with other legally
marketed tobacco products (such as may be beneficial to an individual is show that the product does not raise
available delivery systems), as well as different than whether a category of different questions of public health
the type and range of other products products, overall, has a net positive (section 910(a)(3)(A)(ii)).
with which it is likely to be used. benefit on population health. As (Comment 17) A few comments
For example, where a manufacturer explained in the NPRM, a category of argued that section 910(a)(3)(A)(ii)
seeks authorization of a new e-liquid to products may benefit some individual allows for cross-category comparisons
be used with ENDS, the manufacturer tobacco users but may not have an (i.e., applicants may provide a
may need to provide evidence and overall net population health benefit if comparison to predicate products from
analysis of the product’s likely impact it leads to increased tobacco product similar (but not identical) tobacco
when used in the range of delivery initiation or dual use. In any event, this product categories).
systems available. Similarly, a is a consideration relevant under the (Response) It is up to the
manufacturer seeking authorization of a PMTA standard, not the SE standard. manufacturer to select an appropriate
stand-alone apparatus component— Under section 910(a)(3)(A)(ii), a predicate tobacco product and provide
such as a heating coil or cartridge—may product can be found substantially the scientific evidence demonstrating
need to provide evidence and analysis equivalent to a predicate product even SE. If the manufacturer provides
of the product’s likely impact when if it does not share all of the same scientific evidence and a rationale that
used together with the range of other characteristics of the predicate, if the demonstrates to FDA that the new
components and liquids available. information submitted contains product does not raise different
In the case of e-liquids, FDA expects information, including clinical data if questions of public health than the
that it may be possible for deemed necessary by the Secretary, that predicate (even though there are
manufacturers to satisfy the statute by demonstrates that it is not appropriate differences from the predicate product),
demonstrating that marketing of the to require a new product application FDA could issue an SE order. However,
liquid is appropriate for the protection because the product does not raise manufacturers of cigars or ENDS would
of public health as it may be used in any different questions of public health as have great difficulty showing that a
of the legally available delivery systems. compared to the predicate. product is substantially equivalent to a
While FDA recognizes that there may FDA will authorize the marketing of combusted cigarette or a smokeless
remain some degree of uncertainty in products through the SE pathway that tobacco product. For example, if FDA
any such analysis, FDA expects that the meet the applicable standards in the received an SE Report for a new product
range of delivery system specifications FD&C Act. However, the SE pathway is that is an ENDS closed aerosol
authorized by FDA will provide a a comparison between a new tobacco generating apparatus and a predicate
sufficiently specific spectrum of product and a predicate identified by product that is a filtered combusted
possibilities, such that a meaningful the submitter, not an evaluation of cigarette, then the product
public health impact analysis can be whether the product is appropriate for characteristics between the new and
done. the protection of the public health more predicate products would be different.
In the case of ENDS hardware/ generally as would be conducted under Because of the differences in
apparatus components, FDA expects an application under section 910(b) (i.e., characteristics in this example, a
that it may be difficult for a PMTA). Therefore, some differences significant amount of scientific evidence
manufacturers to make the showing between new and predicate products would be needed to demonstrate that
necessary to meet the statutory may not be appropriate for an SE the new product does not raise different
standard, given the great extent of Report, and the product instead is more questions of public health. Such
possible variations in combinations of suited to seeking authorization using a evidence, as discussed in FDA’s 2011
hardware components, if all are PMTA. Additionally, as the SE pathway Guidance titled ‘‘Section 905(j) Reports:
considered and sold separately. Thus, is a specific comparison between a Demonstrating Substantial
with respect to apparatus, FDA expects predicate and a new tobacco product, it Equivalence,’’ could include but would
that manufacturers will be most does not necessarily provide a pathway not be limited to the following: (1)
successful where authorization is sought to market for entire categories of Smoke yield data from HPHCs, (2)
for entire delivery systems, rather than products. Rather, under section actual use data demonstrating how
individual components. In the case of 910(a)(3)(A)(ii), an application for SE smoke topography compares between
these complete delivery systems— must show that any differences in the new and predicate products, (3)
systems for which the application characteristics between the product and actual use data demonstrating how the
covers all potential parts, including the predicate ‘‘do not raise different amount of product use varies between
customizable options as applicable, and questions of public health.’’ the new and predicate products (e.g.,
where labeling, instructions for use and/ (Comment 16) A small number of number of puffs per day), and (4)
or other measures are used to help comments argued that newly deemed marketing data indicating how
ensure use as intended—FDA expects products should be permitted to be consumer perception (product appeal)
that the range of possible outcomes may marketed under the SE pathway even if by youth differs between the new and
be narrow enough for the manufacturer they do not share the same predicate products. In these cases, it
to demonstrate, and for FDA to assess, characteristics as the claimed predicate. would be difficult to show that the
public health impact. (Response) The statute does allow for differences between the product and the
(Comment 15) Some comments applicants to use the SE pathway for predicate product are such that the
asserted that under section new tobacco products that have product ‘‘does not raise a different
910(a)(3)(A)(ii) of the FD&C Act, certain different characteristics than the question of public health.’’
categories of products should easily predicate product. To receive a In addition, the evidence required to
meet the SE standard because the marketing authorization under the SE make such a showing may be as
products, overall, are beneficial to pathway, these applicants must show substantial or even greater than the
public health when compared to that the new product has different evidence required under the PMTA
traditional, combustible cigarettes. characteristics and the information pathway (section 910(b)), and the PMTA
(Response) The issue of whether a submitted contains information, pathway allows for different effects on
product or certain categories of products including clinical data if necessary, to public health—as long as the applicant
provides a demonstration that the test markets) that was not commercially contended that ‘‘all newly deemed
product is appropriate for the protection marketed in the United States on products will be forced from the
of the public health. Nevertheless, there February 15, 2007. For purposes of the market.’’ Thus, they argue, decisions
is nothing in the statute to prohibit the SE pathway, the statute also clearly were made to invest in an industry that
attempted use of cross-category states that a predicate product must be was presumed to be unregulated, and
comparisons in an SE submission, but it commercially marketed (other than for now the industry must bear
is the responsibility of the manufacturer test marketing) in the United States on unanticipated costs.
to provide appropriate and sufficient February 15, 2007, in both section (Response) FDA disagrees with
evidence to support a finding of SE. 910(a)(2)(A) and section 910(j)(1). FDA’s comments stating that all newly deemed
(Comment 18) A few comments from authority is not so broad as to allow products will be forced to be removed
industry argued that FDA should FDA to issue a regulation that from the market as some newly deemed
interpret ‘‘substantial equivalence’’ as contradicts a clear statutory provision. products will qualify as ‘‘grandfathered’’
the term is applied to medical devices Many comments cited examples of products under the statute and any that
under section 510(k) of the FD&C Act FDA’s exercise of discretion to show are not grandfathered will be able to
(21 U.S.C. 360(k)), which does not that FDA can and should exercise apply for premarket authorization. The
require premarket review for what the discretion to change the grandfather Tobacco Control Act plainly provides
comments refer to as ‘‘even the slightest date. For example, comments pointed to for regulation of all tobacco products.
change to a predicate.’’ FDA’s decision to extend compliance FDA also clearly stated its intention to
(Response) FDA’s interpretation of SE deadlines, as well as FDA’s guidance deem these products long before the
with respect to medical devices is based informing industry that it does not NPRM was published (see Unified
on a different statutory section than is intend to take enforcement action Agenda, Spring 2011, RIN 0910–AG38).
applicable to tobacco products. FDA has against manufacturers who make Therefore, manufacturers of the newly
issued guidance interpreting SE within tobacco blending changes without a deemed products have been on notice
the meaning of section 910 of the FD&C premarket submission for a new tobacco for more than 4 years that these
Act. product when such tobacco blending products could and likely would be
C. Comments on the Grandfather Date changes are intended to address the regulated.
natural variation of tobacco (e.g., The ENDS industry has acknowledged
We received numerous comments on tobacco blending changes due to that it was aware of both FDA’s
the February 15, 2007, grandfather date variation in growing conditions). intention to regulate ENDS and the
and the challenges it may present to However, the exercise of discretion applicability of the Tobacco Control Act
certain categories of the newly deemed reflected in these examples did not to e-cigarettes and other ENDS, as
products. We address those comments require FDA to contradict the clear evidenced by the litigation in Smoking
as follows. language of the Tobacco Control Act, as Everywhere, Inc. v. Food & Drug
Lack of Authority To Change the changing the grandfather date would. Administration, 680 F. Supp.2d 62
Grandfather Date to a Later Date. As (Comment 20) A number of comments (D.D.C. 2010), affirmed by Sottera, Inc.
stated in the NPRM, FDA has argued that the February 15, 2007, date v. Food & Drug Administration, 627
determined that it lacks authority to in section 910 of the FD&C Act is simply F.3d 891 (D.C. Cir. 2010), which was
change the grandfather date, which is an anachronism, that the date was only pending during the passage of the
set by statute (79 FR 23142 at 23174). intended to apply to the initially Tobacco Control Act. When FDA
FDA specifically asked for comments on regulated products, and the fact that the attempted to regulate e-cigarettes as a
our legal interpretation. We received a statutory language does not provide a drug-device combination, plaintiffs
large number of comments in response different date is simply a drafting error. Sottera (doing business as NJOY) and
to this statement, but none provided a (Response) FDA disagrees and is Smoking Everywhere argued that
legal theory that would support aware of no evidence supporting this Congress intended for tobacco products,
changing the date. view. Congress carefully distinguished including their own, to be subject to the
(Comment 19) A number of comments those provisions of the statute that Tobacco Control Act and not to the drug
argued that adoption of a later would apply to all tobacco products and device provisions of the FD&C Act.
grandfather date would be an acceptable from those that would apply only to the The district court described plaintiffs’
exercise of FDA’s discretion under initially regulated products or, in some position as follows: ‘‘In FDA v. Brown
section 701(a) of the FD&C Act, which cases, only to traditional cigarettes. (See, and Williamson Tobacco Corp., the
provides FDA authority to issue e.g., section 102(a)(1) of the Tobacco Supreme Court held that tobacco
regulations ‘‘for the efficient Control Act (requiring FDA to issue a products, like traditional cigarettes, are
enforcement’’ of the statute. Others rule establishing restrictions on the sale not subject to FDA regulation as a drug
argued that an alternative date would be and distribution of cigarettes and or device. [529 U.S. 120 (2000).]
a permissible Agency interpretation of smokeless tobacco, with certain Because electronic cigarettes, as
the statute, subject to deference under different provisions for the two marketed by plaintiffs, are the
the Chevron doctrine. (See Chevron categories of products).) If Congress had functional equivalent of traditional
U.S.A., Inc. v. NRDC, 467 U.S. 837 intended that there be a later cigarettes, plaintiffs contend that FDA
(1984).) grandfather date for tobacco products cannot regulate their products [as
(Response) After careful consideration deemed subject to the statute after its combination drug-device products].
of these comments, FDA concludes that date of enactment, it would have They further contend that Congress’s
it lacks authority to change the provided one. recent enactment of the [Tobacco
grandfather date for the newly deemed (Comment 21) Some comments Control Act] supports their argument.
products. The grandfather date is argued that application of the February Under the [Act], FDA may now regulate
prescribed in the statute. Section 15, 2007, date is unfair to the tobacco products, which the Act defines
910(a)(1)(A) of the FD&C Act states, in manufacturers of the newly deemed as ‘‘any product made or derived from
pertinent part, that the term ‘‘new tobacco products (particularly e- tobacco that is intended for human
tobacco product’’ means any tobacco cigarettes) because they were not on consumption,’’ . . . but it cannot
product (including those products in notice of pending regulation and they regulate those products as it would a
drug or device under the FDCA[.] There not list the grandfather date for the use that can be shown to be substantially
being no dispute that the nicotine in of nontobacco brand-names as one of equivalent to a product that was on the
plaintiffs’ electronic cigarettes is the exceptions. Nonetheless, the Agency market on the grandfather date. If that
naturally distilled from actual tobacco issued a compliance policy stating that showing cannot be made, the
and is intended for human it did not intend to enforce the January appropriate premarket pathway is the
consumption, . . . plaintiffs assert that 1, 1995, grandfather date for the use of premarket tobacco product application
their electronic cigarettes qualify as a a nontobacco brand name while pathway.
tobacco product and are therefore considering what changes to the To obtain marketing authorization
exempt from regulation as a drug-device regulation, if any, would be appropriate. under the PMTA pathway,
combination.’’ (Smoking Everywhere v. Section 102(a)(4) also gave FDA manufacturers are required to establish,
FDA, 680 F. Supp. 2d 62, 66–67 (D.D.C. authority to amend its own rule. On among other things, that permitting
2010).) November 17, 2011, FDA issued the their products to be marketed would be
The district court found that, ‘‘it is proposed brand name rule (76 FR appropriate for the protection of public
apparent from Congress’s broad 71281) seeking to exercise its authority health. In establishing this,
definition of ‘tobacco product’ that it to amend the January 1, 1995, date that manufacturers should take into account,
intended the Tobacco Act’s regulatory was originally included in 21 CFR and FDA will consider, the ways in
scheme to cover far more than the fixed 897.16(a) to June 22, 2009, in which the new product is likely to be
array of traditional tobacco products[.]’’ recognition of the fact that 14 years used. We also note that, elsewhere in
(Id. at 71.) ENDS manufacturers were elapsed since the publication of the this issue of the Federal Register, FDA
made especially aware of FDA’s 1996 final rule. Using the January 1995 has made available draft guidance,
authority to deem their products and date would have significantly changed which when final will describe FDA’s
subject them to the tobacco control the provision, from one that was current thinking regarding some
authorities of the FD&C Act when the intended to apply prospectively to one appropriate means of addressing the
court noted that ‘‘. . . now that FDA has that applies retroactively. The statute premarket authorization requirements
regulatory power over electronic does not give FDA similar authority to for newly deemed ENDS products.
cigarettes through the Tobacco Act, any change the provisions in section 910 of Should firms have specific questions
harm to the public interest or to third the FD&C Act to amend the grandfather regarding application content and
parties caused by an injunction that date. information necessary to satisfy the
merely forbids FDA from regulating filing criteria under section 910(b) or
electronic cigarettes as a drug-device D. Impact of Premarket Requirements ways to reduce burden by reference to
combination is greatly diminished.’’ (Id. (Comment 23) Numerous comments another submission, they may contact
at 77–78.) argued that if the SE pathway is not CTP’s OS at 1–877–CTP–1373.
On appeal, the D.C. Circuit affirmed, available for some newly deemed For example, where a manufacturer
commenting that ‘‘the Tobacco Act products, manufacturers will have to seeks authorization of a new e-liquid to
provides the FDA with regulatory use the PMTA pathway, will not have be used with ENDS, the manufacturer
authority over tobacco products without sufficient resources to complete PMTAs, may need to provide evidence and
requiring therapeutic claims. . . . [T]he and will be forced to remove their analysis of the product’s likely impact
act broadly defines tobacco products as products from the market. Members of when used in the range of delivery
extending to ‘any product made or the e-cigarette industry further argued systems available. Similarly, a
derived from tobacco.’ ’’ Sottera, Inc. v. that removal of their products would be manufacturer seeking authorization of a
Food & Drug Administration, 627 F.3d detrimental to public health. However, stand-alone apparatus component—
891, 897 (D.C. Cir. 2010) (quoting 21 other comments expressed concern such as a heating coil or cartridge—may
U.S.C. 321(rr)(1); emphases added by regarding any delay in implementing need to provide evidence and analysis
the court). The D.C. Circuit went on to and enforcing the premarket review of the product’s likely impact when
state that ‘‘the [lower] court rightly requirements given the data showing the used together with the range of other
found that the FDA has authority under growing use of the newly deemed components and liquids available.
the Tobacco Act to regulate electronic products, particularly among youth and In the case of e-liquids, FDA expects
cigarettes’’—authority that, it added, young adults. that it may be possible for
was ‘‘unquestioned.’’ Id. at 898. (Response) As an initial matter, FDA manufacturers to satisfy the statute by
(Comment 22) Some comments notes that the primary premarket demonstrating that marketing of the
argued that FDA previously exercised pathway for new tobacco products is the liquid is appropriate for the protection
enforcement discretion to amend the premarket tobacco product application of public health as it may be used in any
grandfather date of the reissued 1996 pathway, and that the SE and SE of the legally available delivery systems.
rule (published in the Federal Register exemption pathways are exceptions to While FDA recognizes that there may
of August 28, 1996, 61 FR 44396) with that pathway, but manufacturers can remain some degree of uncertainty in
respect to use of a trade or brand name choose to submit applications under any any such analysis, FDA expects that the
of a nontobacco product for cigarettes or of the three pathways for which they range of delivery system specifications
smokeless tobacco products and argued think they can meet the criteria in the authorized by FDA will provide a
that FDA has the authority to take FD&C Act for marketing authorization sufficiently specific spectrum of
similar action with respect to the SE for a new product. See section possibilities, such that a meaningful
grandfather date. 910(a)(2)(A) of the FD&C Act stating that public health impact analysis can be
(Response) FDA disagrees. In section an order for a new tobacco product is done.
102 of the Tobacco Control Act, required unless the Secretary has issued In the case of ENDS hardware/
Congress required FDA to reissue the an order that the tobacco product is apparatus components, FDA expects
1996 final rule regarding cigarettes and substantially equivalent to tobacco that it may be difficult for
smokeless tobacco identical to the product commercially marketed. The SE manufacturers to make the showing
original rule (61 FR 44396 at 44615 pathway is not intended to be available necessary to meet the statutory
through 44618), with certain to every product. Rather, by its terms, standard, given the great extent of
enumerated exceptions. Congress did the SE pathway is limited to products possible variations in combinations of
hardware components, if all are less information will be required in of newly deemed products that are sold
considered and sold separately. Thus, PMTAs for e-cigarettes than for other or distributed solely for further
with respect to apparatus, FDA expects products. manufacturing without a marketing
that manufacturers will be most (Response) The requirements and order.
successful where authorization is sought costs of a PMTA may vary based on the (Comment 27) Many expressed
for entire delivery systems, rather than type and complexity of the product. concern that requiring cigars to comply
individual components. In the case of Variations in the ratio of ingredients, with the PMTA requirements would
these complete delivery systems— such as propylene glycol and glycerin, either force cigars off the market or
systems for which the application would indicate that products have require them to mimic cigarettes in
covers all potential parts, including different levels of each of these uniformity of size, shape, and taste,
customizable options as applicable, and ingredients. As stated in section which would change the fundamental
where labeling, instructions for use and/ 910(a)(1)(B) of the FD&C Act, any nature of the cigar industry. At least one
or other measures are used to help change in an ingredient level, as with comment stated that FDA should
ensure use as intended—FDA expects additions or removal of ingredients, eliminate the premarket and SE
that the range of possible outcomes may yields a new tobacco product. application requirements for cigars and
be narrow enough for the manufacturer We also note that the statute requires instead implement a system by which
to demonstrate, and for FDA to assess, FDA to review PMTAs based on well- cigar manufacturers could introduce
public health impact. controlled investigations, ‘‘when new products to the market after
FDA also notes that many comments appropriate,’’ or other valid scientific providing 90 days’ notice to FDA of
from the ENDS industry emphasized the evidence sufficient to evaluate the their intentions to do so.
potential public health benefits of these tobacco product. In addition, elsewhere (Response) FDA disagrees. Sections
products in their comments on the in this issue of the Federal Register, 905 and 910 of the FD&C Act establish
NPRM. For example, numerous industry FDA has made available draft guidance, specific requirements that apply to new
comments argued that restrictions on which when final will describe FDA’s tobacco products before they may be
access to the newly deemed products current thinking regarding some marketed. Some cigars may be
would be detrimental to public health, appropriate means of addressing the grandfathered and other products may
as the products may be less toxic than premarket authorization requirements have valid predicate products and may
conventional cigarettes and may be for newly deemed ENDS products. be able to avail themselves of the SE
successfully used as a cessation Should firms have specific questions pathway to market. FDA generally
product. FDA’s consideration of public regarding application content and expects that cigars with blending
health benefits of products will be information necessary to satisfy the changes (other than blending changes to
included in FDA’s review of PMTAs filing criteria under section 910(b) or address the natural variation of tobacco,
based on the evidence. ways to reduce burden by reference to FDA’s policy for which is discussed in
(Comment 24) A few comments another submission, they may contact the response to Comment 28) will be
expressed concern that if manufacturers CTP’s OS at 1–877–CTP–1373. able to successfully use the SE pathway
would be forced to submit PMTAs (Comment 26) Many comments stated so long as the blending change does not
rather than SE applications, they would that a requirement to prepare PMTAs for significantly raise levels of HPHCs in
need to conduct more animal studies to all of the many parts and components the product (i.e., raising different
meet PMTA requirements. that go into some of the newly deemed questions of public health). If a product
(Response) FDA shares an interest in tobacco products would create an is unable to utilize the SE pathway and
reducing the reliance on animal-based effective ban of these products. is not eligible for an SE exemption, the
studies, and the Agency is committed to (Response) The definition of a tobacco statute requires the product (including
the three ‘‘Rs’’ of reduction, refinement, product includes components and parts, limited or seasonal blends) to obtain a
and replacement in animal testing. and these products are subject to the marketing authorization through the
Although we are hopeful that in vitro automatic provisions of the FD&C Act, PMTA pathway. As explained
assays and computer models can including premarket authorization previously, the requirements of a
ultimately help to replace much of the requirements. However, at this time, particular PMTA may also vary based
need for animal testing, there are still FDA intends to limit enforcement of the on the type and complexity of the
many areas for which non-animal premarket authorization provisions to product. If an applicant wishes to
testing is not yet a scientifically valid finished tobacco products. In this discuss a product application, the
and available option. FDA is committed context, a finished tobacco product applicant may request a meeting as set
to addressing concerns raised regarding refers to a tobacco product, including all forth in FDA’s final guidance entitled
use of animal testing methods, while components and parts, sealed in final ‘‘Meetings with Industry and
still ensuring that the Agency satisfies packaging intended for consumer use Investigators on the Research and
its public health and patient safety (e.g., filters or filter tubes sold Development of Tobacco Products’’
responsibilities and acts in accordance separately to consumers or as part of (announced May 25, 2012, 77 FR
with its governing statutes. kits). For example, an e-liquid sealed in 31368).
(Comment 25) One comment stated final packaging that is to be sold or (Comment 28) A number of comments
that e-cigarettes have two variables—the distributed to a consumer for use in a discussed the natural variability in the
ratio of the propylene glycol to finished tobacco product will be subject tobacco used for cigars and pipe
vegetable glycerin and the level of to enforcement if it is on the market tobacco, stating that because the
nicotine in the product—which would without authorization. In contrast, an e- characteristics of tobacco used for each
result in many combinations and, liquid that is sold or distributed for of these products can vary from year to
therefore, require submission of further manufacturing into a finished year, manufacturers must use different
numerous, very costly PMTAs for ENDS product is not itself a finished blends to create a consistent product.
products that have very minor tobacco product. At this time, FDA does Some comments expressed concerns
variations. In contrast, one comment not intend to enforce the premarket that each blending change could result
noted that the lower number of authorization requirements against such in a new product for which
ingredients in e-cigarettes means that e-liquids or other components and parts manufacturers and importers would be
required to submit a PMTA. They also requirements (e.g., ingredient listing) e-liquids, which can be accessible to
stated that this would be economically against manufacturers making blending children and potentially subject to
unfeasible for limited editions and changes to address the natural variation tampering and, therefore, should not
special releases for cigars and pipe of tobacco. receive additional time to comply with
tobacco. Others expressed concerns that (Comment 29) Some comments stated critical automatic requirements. Third,
tobacco blending changes and natural that small companies are at a they stated that Congress did not intend
variations of the tobacco used in the competitive disadvantage compared to for small manufacturers to have
product, such as the number of ribs or larger companies because they do not additional time to comply with all of the
perforations in a cigar wrapper, may have the resources to complete PMTAs. automatic provisions under the law
produce different results for HPHC They feared that FDA’s premarket once they are deemed. Instead, Congress
testing of the same product. These requirements would force many only intended that small manufacturers
comments advocated that cigars and companies to remove their products receive additional time to comply with
pipe tobacco should be either excluded from the market and that, as a result, good manufacturing practices under
from the ingredient listing, HPHC cigarette use would increase. To address section 906(e)(1)(B) of the FD&C Act and
listing, and premarket review these concerns, comments suggested testing requirements under section
requirements or manufacturers should that FDA stagger requirements based on 915(d) (21 U.S.C. 387o). If Congress had
be allowed to make tobacco blending the size of the business to protect small intended for small manufacturers to
changes without being required to businesses and spur innovation. They receive additional time to comply with
submit a marketing application or stated that staggered compliance periods other provisions, it would have
comply with HPHC testing and could be based on the number of explicitly said so. Fourth, they stated
reporting requirements. employees in the business, number of that FDA already provides adequate
products the business has, and/or the assistance to small businesses with the
(Response) FDA is aware that the
product’s placement on the continuum small business center (included as part
tobacco used to produce some of the
of risk. In addition, some comments of CTP’s OCE) and frequent Webinar
newly deemed products can naturally
stated that such staggered dates could be programs, but other comments stated
vary from year to year. As stated in
based on FDA’s issuance of final PMTA that the small business center was not
section IV.C.1, FDA does not intend to
guidance for each product category, properly organized and staffed.
enforce the premarket authorization
which would allow for more meaningful (Response) FDA is announcing
requirements where manufacturers and complete submissions. They also multiple policies with this final rule
make tobacco blending changes without stated that, because such guidance including a policy for ‘‘small-scale
premarket authorization for tobacco likely would include issues of first tobacco product manufacturers’’
blending changes to address the natural impression, the Agency is required to discussed in section IV.D. FDA is
variation of tobacco (e.g., tobacco first issue the guidance in draft form announcing this policy, because ‘‘small-
blending changes due to variation in before issuing a final guidance. Some scale tobacco product manufacturers’’
growing conditions) in order to comments stated that staggered PMTA do not have the same business
maintain a consistent product. However, compliance periods may not be capabilities of larger businesses.
FDA does intend to enforce the sufficient to address the competitive Moreover, FDA did not receive any
premarket authorization requirement for disadvantage of small companies comments from large manufacturers
tobacco blending changes that are because they still would not have the suggesting that they are in need of the
intended to alter the chemical or resources to complete a PMTA for each relief that is being provided for small-
perception properties of the new of their new tobacco products. scale tobacco product manufacturers.
product (e.g., nicotine level, pH, Other comments believed that Congress also acknowledged the
smoothness, harshness, etc.) compared premarket requirements should apply potential disparity by requiring FDA to
to the predicate product, and such equally to all manufacturers, regardless establish the Office of Small Business
changes should be reported under 910 of size, for several reasons. First, they Assistance (OSBA) within CTP to assist
or 905(j). In addition, FDA intends to explained that the FD&C Act states that small tobacco product manufacturers
issue a guidance regarding HPHC the purpose of a PMTA is to ensure that and retailers in complying with the law.
reporting under section 904(a)(3), and permitting marketing of a tobacco OSBA is available to assist
later a testing and reporting regulation product would be ‘‘appropriate for the manufacturers with any questions
as required by section 915, with enough protection of the public health’’ (section regarding statutory and regulatory
time for manufacturers to report given 910(c)(2)(A)) and that this public health requirements and will continue to
the 3-year compliance period for HPHC purpose should outweigh concerns provide support with respect to these
reporting. As noted elsewhere in this regarding small businesses. The newly finalized regulations. Small
document, FDA does not intend to comments noted that the public health business owners may contact the OSBA
enforce the reporting requirements purpose of the Tobacco Control Act by calling 1–877–CTP–1373 or sending
under section 904(a)(3) for newly does not differentiate between large and a message to SmallBiz.Tobacco@
deemed products before the close of the small businesses. Second, they stated fda.hhs.gov. FDA intends to expand the
3-year compliance period, even if the that the public health concerns staffing for the OSBA to provide support
HPHC guidance is issued well in presented by products of small for manufacturers who are newly
advance of that time. Additionally, manufacturers are no less significant regulated by FDA.
changes made to the number of ribs or than the public health concerns As discussed in the earlier section of
perforations in a cigar wrapper as well presented by products of large this final rule describing the purpose of
as any changes to ingredients or manufacturers. They also noted that this rule, FDA will be able to obtain
additives, would result in a new tobacco small manufacturers may lack the critical information regarding the health
product (as stated in section quality control processes that they risks of newly deemed tobacco
910(a)(1)(B)) and would require a believed large manufacturers already products, including information derived
marketing application and authorization have in place. They also noted that from ingredient listing submissions and
under section 910 or 905(j). FDA many small businesses are e-cigarette reporting of HPHCs. Because FDA did
intends to enforce other applicable retail establishments that mix their own not previously have regulatory authority
over these products, it does not have statements regarding clinical studies do not apply to tobacco products. FDA’s
access to commercial confidential needed for PMTAs (79 FR 23142 at responses to these individual
information on materials, ingredients, 23176 and 23177). As we noted, FDA suggestions are discussed in the
design, composition, heating source and expects that, in some cases, it may be following paragraphs.
other features of these products. As FDA possible for an applicant to obtain a • Create a user registry for e-cigarette
gains experience regulating these newly PMTA marketing authorization order users to input baseline demographic,
deemed tobacco products, the Agency without conducting any new cessation and initiation, adverse
expects there will be more information nonclinical or clinical studies where experiences, and follow-up data for
to aid manufacturers seeking premarket there is an established body of evidence collection of real-world data—
determination that a tobacco product is regarding the public health impact of The data and information in a PMTA
‘‘appropriate for the protection of public the product. However, in cases where must be sufficient to show that the
health.’’ However, it would negatively there have been few or no scientific marketing of the specific new tobacco
impact public health if FDA were to studies of a product’s potential impact product is ‘‘appropriate for the
significantly delay implementation of its on the public health, new nonclinical protection of the public health’’ (section
premarket requirement authorities after and clinical studies may be required for 910(c)(4) of the FD&C Act). This
issuance of this deeming rule. Such market authorization. In addition, information from a user registry would
delay could result in more youth elsewhere in this issue of the Federal not be sufficient on its own to support
becoming addicted to nicotine. FDA Register, FDA is announcing the a marketing application, but it could
recognized that ENDS are different than availability of a draft guidance, which provide additional real-time information
conventional tobacco products, and that when final will provide the Agency’s (e.g., adverse experiences that may
more specific guidance would be useful current thinking regarding some otherwise be gathered in more long-term
to manufacturers in preparing premarket appropriate means of addressing the studies). If an applicant wishes to use a
applications. Therefore, FDA has made premarket authorization requirements registry or other alternatives, we
available draft guidance, which when for newly deemed ENDS products, encourage it to request a meeting with
final, will describe FDA’s current including the need for ‘‘clinical studies’’ FDA to discuss these and other issues
thinking regarding some appropriate for the purposes of preparing PMTAs for before it prepares and submits an
means of addressing the premarket ENDS. application.
authorization requirements for newly (Comment 31) Several comments • Identify clinical studies that will
deemed ENDS products, including suggested that section 910(c)(5)(B) constitute ‘‘valid scientific data’’ and
recommendations that would help to provides FDA with authority to develop identify historical controls and
support a showing that the marketing of a flexible framework for PMTAs that published literature deemed suitable for
a product is appropriate for the would not require well-controlled comparative purposes—
protection of public health. FDA intends investigations. They suggested the FDA does not have enough
to issue additional guidance in the following alternatives to the information at this time to do this in a
future. requirement of well-controlled manner that would be generally
investigations: applicable. It may be possible for an
E. Clinical Studies and PMTAs
• Create a user registry for e-cigarette applicant to submit information (e.g.,
(Comment 30) Comments expressed users to input baseline demographic, published literature, marketing
concern about the need for costly cessation and initiation, adverse information) with appropriate
clinical studies to develop PMTAs that experiences, and followup data for information or data that would be
satisfy the requirements under section collection of real-world data; adequate scientific data for parts of the
910 of the FD&C Act. They indicated • Identify clinical studies that will application. This will likely be limited
that FDA’s previous statements, constitute ‘‘valid scientific data’’ and to specific aspects of the PMTA
including language from draft guidance identify historical controls and requirements (e.g., nonclinical work,
that recommends the collection of published literature suitable for shelf life/stability, health risks based on
numerous types of data ranging from comparative purposes; consumer information). If an applicant
chemistry to in vivo toxicology and • Adopt a process similar to FDA’s wishes to use this or other alternatives,
possible clinical trials, suggest the need process for new medical devices, where we encourage them to request a meeting
for costly studies that are redundant and the product can undergo de novo review with FDA to discuss these and other
unnecessary. They also noted the to obtain a lower risk classification and issues in the context of a particular
Government Accountability Office’s be subject to general controls and product before they prepare and submit
(GAO’s) summary of this issue, which specific controls (rather than the an application.
stated ‘‘CTP’s guidance document for premarket requirements under sections • Adopt a process similar to FDA’s
the PMTA pathway states that PMTA 905 and 910(d)); process for new medical devices, where
submissions should include data from • Use a process similar to the the product can undergo de novo review
well-controlled studies demonstrating accelerated approval process for new to obtain a lower risk classification and
that the tobacco product is appropriate drugs for serious or life-threatening be subject to general controls and
for the protection of the public health. illnesses, which bases approval on the specific controls (rather than the
[According to CTP,] ’[d]ata from such effect of the drug on a surrogate premarket requirements under sections
studies must address, for example, the endpoint; and 905 and 910(d))—
health risks associated with the product • Adopt a method similar to the FDA is not authorized to deviate from
in comparison to the health risks of dietary supplement process, based on the premarket requirements of chapter
other products on the market and the registration, ingredient disclosures, and IX of the FD&C Act. The medical device
product’s effect on the likelihood that good manufacturing practice (GMP) requirements in chapter V of the FD&C
current tobacco users will stop using compliance checks. Act apply to medical devices only, not
tobacco products’’’ (Ref. 41 at 18–19). (Response) FDA is not implementing tobacco products as defined in section
(Response) In the NPRM, FDA these changes. Most of the approaches 201(rr) of the FD&C Act.
included discussion intended to in the comments are all implemented • Use a process similar to the
supplement and clarify its earlier under different statutory authorities that accelerated approval process for new
drugs for serious or life-threatening controlled investigations it would like product (and its potential risks and
illnesses, which bases approval on the to utilize, we recommend that it meet benefits), all tobacco products going
effect of the drug on a surrogate with FDA to discuss the approach prior through the PMTA pathway must meet
endpoint— to preparing and submitting an all the requirements for a premarket
The purpose of the accelerated drug application (see FDA guidance entitled authorization in section 910 of the
approval process was to establish ‘‘Meetings with Industry and FD&C Act before FDA can issue such an
procedures designed to expedite the Investigators on the Research and authorization. In addition, we note that,
development, evaluation, and marketing Development of Tobacco Products’’). We at this time, while there is general
of new therapies intended to treat also note that, elsewhere in the Federal evidence of harm for all classes of newly
persons with life-threatening and Register, FDA is announcing the deemed products, FDA has not yet
severely debilitating illnesses, availability of a draft guidance, which obtained product-specific evidence
especially where no satisfactory when final will provide the Agency’s regarding the various ENDS on the
alternative therapy exists. This is not current thinking regarding some market. Since ENDS products contain
the case with a tobacco product. Section appropriate means of addressing the nicotine, it is possible that such
910(b) of the FD&C Act requires that premarket authorization requirements products may result in overall public
specific contents be contained in a for newly deemed ENDS products. health harm if individuals who would
PMTA. In addition, as stated in section not have initiated tobacco use in the
910(c)(4) of the FD&C Act, the data and F. Premarket Pathways and Continuum
of Risk absence of ENDS ultimately graduate to
information in a PMTA must be combusted products (though scientific
sufficient to show that the marketing of (Comment 32) We received many data regarding this hypothesis is
a new tobacco product is ‘‘appropriate comments requesting that FDA provide unclear) or use them in conjunction
for the protection of the public health.’’ an expedited or abbreviated pathway for with combusted products or if the users
FDA believes that an accelerated those products that are on the less would never have initiated tobacco use
premarket review process is neither harmful end of the continuum of risk absent the availability of ENDS. In
feasible nor appropriate for these spectrum. Some comments stated that addition, nicotine use in any form is of
products at this time. However, if an noncombusted and nicotine delivery particular concern for youth and
applicant believes it can demonstrate products derived from, but not pregnant women. On the other hand, if
that its new product is ‘‘appropriate for containing, tobacco should be treated ENDS promote transition from
the protection of public health’’ in an differently than combusted products for combustible tobacco use among current
accelerated fashion, we encourage it to the purposes of premarket review and
users, there could be a public health
request a meeting with FDA to discuss that less harmful products need an
benefit. The 2014 Surgeon General
these and other issues before they accelerated pathway to ensure
Report notes that ‘‘[f]urther research
prepare and submit an application. continued innovation. They also stated
with attention to their individual and
• Adopt a method similar to the that the different risks and benefits
population-level consequences will be
dietary supplement process, based on associated with tobacco derived
helpful to fully address these questions.
registration, ingredient disclosures, and nicotine delivery products make the
However, the promotion of
GMP compliance checks— PMTA process and FDA’s draft PMTA
As stated in section 910(c)(4) of the noncombustible products is much more
guidance inapplicable. Other comments
FD&C Act, the data and information in likely to provide public health benefits
claimed that e-cigarettes and other
a PMTA must be sufficient to show that tobacco derived nicotine delivery only in an environment where the
the marketing of a new tobacco product products are not tobacco products at all appeal, accessibility, promotion, and
is ‘‘appropriate for the protection of the and do not fit into the strict tobacco use of cigarettes and other combusted
public health.’’ The method suggested product regulatory framework. The tobacco products are being rapidly
in this comment would differ from the comments also stated that an reduced’’ (Ref. 9 at 873). FDA believes
process and standard outlined in abbreviated pathway should be based on that regulation of all tobacco products
sections 905 and 910 of the FD&C Act public participation to decide what will help to address these questions and
and, therefore, is inapplicable to tobacco information is sufficient to determine provide public health benefits.
products. that the product is appropriate for the (Comment 33) Many comments
The FD&C Act states that determining protection of the public health without expressed concern regarding the cost of
whether a new product is appropriate impeding innovation. PMTAs for newly deemed products and
for the protection of the public health Some comments also suggested that the effect that this requirement will
shall be determined ‘‘when appropriate FDA require a premarket notification or have on cigarette smokers who are
. . . on the basis of well-controlled report, similar to EU’s Tobacco Products attempting to quit. They also disagreed
investigations.’’ (section 910(c)(5)(A)). Directive, where the notification with FDA’s assertion that premarket
However, section 910(c)(5)(B) of the certifies that the product has met review will enhance innovation (79 FR
FD&C Act also allows the Agency to specific product standards, and the 23142 at 23149), stating that the cost of
consider other ‘‘valid scientific Agency could approve the product submitting PMTAs is more of a business
evidence’’ if found sufficient to evaluate based on the certification. concern than competition with lower
the tobacco product. Thus, if an At least one comment disagreed with quality products. They claimed that the
application includes, for example, the idea of providing an expedited or PMTA process would have the largest
information (e.g., published literature, abbreviated pathway for some products, negative impact on open system
marketing information) with appropriate stating that FDA will not know if the apparatus, which some comments
bridging studies, FDA will review that products are less harmful until it believed are the most popular with
information to determine whether it is reviews the applications. people who have achieved complete
valid scientific evidence sufficient to (Response) An ENDS is a tobacco substitution from conventional
demonstrate that the product is product as long as it meets the cigarettes to e-cigarettes. The comment
appropriate for the protection of the definition of ‘‘tobacco product’’ under suggests that the result would be that
public health. If an applicant has section 201(rr) of the FD&C Act. newer e-cigarettes would not make it
questions or other alternatives to well- Regardless of the type of tobacco onto the market, driving up prices, and
driving adult consumers back to would have been predicted from these companies already have master
conventional cigarettes. ongoing trends; in both states that did files with FDA for their nicotine
(Response) The Tobacco Control Act and states that did not enact restrictions, products or report that they are ready to
provides for three specific marketing the prevalence of youth smoking file submissions to meet U.S. and EU
pathways for new tobacco products— continued to decline, just at a slower regulatory requirements. An online
SE., SE exemption, and PMTA; it does rate in the states that enacted bans. search of flavor manufacturers revealed
not provide alternative pathways. Finally, given these issues, FDA many suppliers of flavorings that can be
Through the PMTA pathway, FDA will acknowledges this paper as a first added to food or other consumer
ensure that only products that are attempt to study potential impacts of products; any of these products
shown to be appropriate for the youth ENDS access restrictions, but potentially could be used as e-liquid
protection of public health are more research will be necessary to flavoring. However, FDA searches
permitted to be marketed. Use of the explore the potential effects of this rule identified only two to three flavor
PMTA pathway also will allow FDA to on product switching or dual usage. houses that make flavoring specifically
monitor product development and (Comment 34) Some comments for e-liquids.11 Given these realities of
changes and to prevent more harmful or suggested that FDA should establish a the marketplace, FDA expects that the
addictive products from reaching the monograph-like system to allow e- master file system will be widely
market. The PMTA pathway will cigarettes seeking to enter the market to appealing and widely utilized by the
incentivize development of tobacco be compared to a baseline or ‘‘model’’ ENDS industry.
products that pose less risk to human e-cigarette. In addition, a few comments (Comment 35) Comments suggested
health by limiting market access for suggested that combustible product that the ‘‘appropriate for the protection
more-risky competitor products. manufacturers should also be able to of the public health’’ standard for
Furthermore, since the ‘‘appropriate for compare their products to a reference PMTAs was meant for those products
the protection of the public health’’ product to ease SE burdens. with well-established risks to
standard involves comparison to the (Response) FDA disagrees as these consumers and should not apply to e-
general tobacco product market existing suggested alternatives are not consistent cigarettes. They suggested that FDA
at the time of an application, FDA with the Tobacco Control Act. Under establish a different standard for issuing
believes that, over time, the premarket the SE pathway, FDA must determine if PMTA orders for e-cigarettes (i.e., that
authorities will move the market toward the new tobacco product raises different the product is no more hazardous than
less-risky tobacco products. questions of public health than an currently marketed tobacco products).
A recently published paper by identified, and valid, predicate product. (Response) FDA disagrees with
Friedman (Ref. 42) looked at youth To be an eligible predicate product comments suggesting the use of a
smoking rates in states that enacted under section 910 of the FD&C Act, the different standard for e-cigarettes and
early bans on sales of e-cigarettes to product must have been commercially
other ENDS. Section 910(c)(4) specifies
minors. The author concluded, based on marketed in the United States on
the standard FDA is to apply in
state-level combusted cigarette smoking February 15, 2007, or been previously
deciding whether to issue a PMTA
data available through 2013, that the found substantially equivalent.
Moreover, elsewhere in this issue of marketing authorization order. That
decline in adolescent smoking rates
the Federal Register, FDA has made section states that the product must be
slowed in states that enacted restrictions
available a final guidance to provide ‘‘appropriate for the protection of the
on access to ENDS by minors before
information for manufacturers on how public health’’ which ‘‘shall be
January 2013, relative to states that did
to establish and reference a Tobacco determined with respect to the risks and
not. Some have interpreted the results of
Product Master File (TPMF). We expect benefits to the population as a whole,
the study as providing evidence that any
policies that restrict access to e- reliance on TPMFs to increase efficiency including users and nonusers of the
cigarettes or regulate e-cigarettes could and reduce any burdens on tobacco product, and taking into
increase consumption of combusted manufacturers. As discussed in section account—(A) the increased or decreased
tobacco products. However, the research IX, because of the nature of upstream likelihood that existing users of tobacco
has several limitations that are supply of many components for ENDS products will stop using such products;
acknowledged in the study. First, the products, especially e-liquids, FDA and (B) the increased or decreased
survey data used in the study, from the anticipates that commercial incentives likelihood that those who do not use
NSDUH, track changes in the prevalence will be sufficient to drive manufacturer tobacco products will start using such
of cigarette smoking but lack reliance on the system of master files. products.’’ FDA is not authorized to
information available on e-cigarette use. We note that, at present, FDA deviate from this statutory standard.
As such, the study does not establish understands that, based on the Agency’s (Comment 36) Some comments
that youth switched directly from using review of publically available data, the recommended that FDA deem products
ENDS to smoking combusted cigarettes number of entities engaged in upstream currently on the market without
after restrictions on sales of e-cigarettes production of liquid nicotine and subjecting those products to the statute’s
to minors were enacted, only that the flavors specifically developed for use premarketing requirements. Similarly,
decline in prevalence of cigarette with e-liquids is small. Specifically, some comments argued that the
smoking slowed in states where such based on internet searches and premarket requirements should not
restrictions were enacted relative to information provided on firm Web sites, apply to specific categories of products
states that did not. Second, the fact that FDA estimates that there are roughly (specifically, e-cigarettes and other
the study examines a period very early five to ten major pure liquid nicotine novel tobacco products), including
on in the development of the market for suppliers, most of which claim to have those that are introduced after the
ENDS products may also limit the a significant market share.10 Several of enactment of the rule. They stated that
inferences that can be drawn for
11 FDA Internet searches included review of Web
substitution and dual usage patterns 10 See, e.g., Ref. 43. FDA Internet searches
included review of Web sites identifying product sites identifying product suppliers, such as
that will emerge as the market matures. suppliers, such as www.thomasnet.com and www.thomasnet.com and www.alibaba.com, as well
Third, the ‘‘increase’’ in the prevalence www.alibaba.com, as well as manufacturer Web as manufacturer Web sites and news reports on the
of youth smoking is relative to what sites and news reports on the market. market.
this large burden does not have a clear in this issue of the Federal Register, the most recent SE actions, see http://
benefit to public health. FDA has made available draft guidance, www.fda.gov/TobaccoProducts/
(Response) The statute automatically which when final will describe FDA’s Labeling/MarketingandAdvertising/
subjects deemed products to the current thinking regarding some ucm435693.htm). Previously issued SE
statutory requirements for ‘‘tobacco appropriate means of addressing the orders were for products whose
products’’ in chapter IX of the FD&C premarket authorization requirements applications may differ substantially
Act. Once deemed, the products are for newly deemed ENDS products, from those for the newly deemed
subject to all statutory provisions that including the use of scientific literature. tobacco products. As required by
apply to all tobacco products covered by (Comment 39) Comments section 910(a)(3)(A) of the FD&C Act
the FD&C Act. See section 901(b) of the recommended that FDA issue PMTA and as stated in FDA’s guidance
FD&C Act (‘‘This subchapter shall apply orders based only on HPHC data and documents, the Agency must consider
to all cigarettes, cigarette tobacco, roll- appeal to children, as well as a product characteristics when evaluating
your-own tobacco, and smokeless manufacturer’s postmarketing SE reports. The constituents found in e-
tobacco and to any other tobacco commitments to conduct long-term cigarette aerosol are just some of the
products that the Secretary by studies regarding effects of e-cigarette characteristics that FDA will consider
regulation deems to be subject to this use (similar to the supplemental when reviewing SE reports for e-
subchapter.’’). Section 910, which application processes for new drug cigarettes. Other characteristics include
establishes the procedures that must be applications (NDA) and device the materials, other ingredients, design,
followed before a new tobacco product premarket approval supplement regimes composition, heating source, and other
can be authorized for marketing, is one codified in 21 CFR 314.70 and 814.39, features of the e-cigarette (see section
of the statutory provisions that apply respectively). Comments also suggested 910(a)(3)(B)). We also encourage
automatically to all tobacco products, that FDA create a supplemental PMTA prospective applicants to review the
including newly deemed products. FDA for modifications and minor applications FDA posts on www.fda.gov
believes that the premarket review modifications to tobacco products so for examples of products that have
requirements will, in fact, benefit public each product would not require a full different characteristics but do not raise
health, as discussed in the NPRM (79 FR PMTA. different questions of public health
23142 at 23148 and 23149). (Response) FDA disagrees. The when compared with the specified
(Comment 37) Some comments stated statutory authorities for FDA’s predicate product.
that FDA must get a better scientific regulation of drugs, devices, and (Comment 41) Some comments
understanding of e-cigarettes before tobacco products are different. Section provided several suggestions as to how
finalizing the compliance period for 506A of the FD&C Act (21 U.S.C. 356a) FDA can craft the PMTA process to
premarket review of these products. One authorizes FDA to utilize a acknowledge the position of e-cigarettes
comment also proposed a system in supplemental NDA process allowing on the continuum of nicotine-delivering
which FDA could create product manufacturers to make manufacturing products. For example, they indicated
standards under section 907 of the changes to approved drugs and section that e-cigarettes should not need to
FD&C Act for the entire category of e- 515 (21 U.S.C. 360e) allows device undergo a rigorous, comprehensive
cigarettes and then approve or reject manufacturers to supplement their premarket review process and, instead,
PMTAs for individual e-cigarettes based premarket approval applications for should be given an abbreviated pathway
upon whether they meet the standards. modifications to products. Although that would allow FDA to achieve the
(Response) FDA disagrees with FDA does not have the same ability to same objectives. For example, some
comments suggesting that the Agency allow an applicant to obtain an comments suggested that, in order to
needs additional time before authorization and later supplement the streamline the process, a PMTA for an
determining an appropriate compliance application (given the different statutory e-cigarette should be required to contain
period for the premarket review scheme for tobacco products), FDA is only the following: (1) A sample of the
requirements for ENDS. As we have actively considering other opportunities product; (2) specimens of proposed
stated throughout the document, FDA for efficiency and streamlining in the labeling; (3) a description of the
has data regarding health harms PMTA process, consistent with its product’s principles of operation; (4)
generally associated with all of the mission to protect the public health. ingredient listing for e-liquids; (5) a
categories of tobacco products regulated (Comment 40) One comment description of methods of
under this rule (including ENDS). FDA suggested that FDA publish guidance on manufacturing and processing; and (6) a
is regulating these products in how the Agency will determine whether description of quality control and
accordance with this knowledge. FDA an e-cigarette is substantially equivalent product testing systems. They suggested
also disagrees with comments to a predicate product. According to this that FDA could require e-cigarettes to
suggesting that FDA can change the comment, the SE review should focus comply with product standards once
statutory requirements and standards for on the aerosol delivered to the they are established.
issuing PMTA orders. FDA’s revised consumer to determine whether a new Other comments urged FDA to impose
compliance policy for submission of e-cigarette raises different questions of strict regulations on the sale of e-
PMTAs and other premarket public health. cigarettes, including extensive
submissions is discussed in section V.A. (Response) FDA may issue guidances premarket review, to ensure that future
(Comment 38) At least one comment for specific product categories at a later generations are not burdened by
suggested that applicants be able to date. However, FDA finds that the nicotine addiction. While some of these
utilize publications regarding scientific available guidance for SE reports should comments noted that there may be
understanding of e-cigarettes as harm be sufficient to assist manufacturers in potential benefits to some individuals,
reduction products to support their preparing reports and to advise them of they believed the Agency cannot lower
PMTAs. the factors FDA considers when its scientific standards, weaken its
(Response) FDA agrees that applicants assessing SE reports, as evidenced by requirements for rigorous science, or
can include scientific literature as part the fact that the agency has issued many change its requirements for evaluating
of their PMTA submission pursuant to orders regarding SE to applicants that the public health impact of e-cigarettes.
section 910(b)(1). In addition, elsewhere have utilized the available guidance (for To determine eligibility for expedited
review or an abbreviated pathway, these marketing applications, FDA has issued as an adult consumer product without
comments stated that FDA must several guidance documents, and is providing additional details.
recognize that: (1) The use of any finalizing other guidance documents, (Response) It is unclear what this
tobacco product, including a well- regarding the evidence needed for SE comment envisioned by suggesting that
regulated e-cigarette, poses a greater risk reports, including FDA draft guidance FDA regulate e-cigarettes as an adult
than using no tobacco product; and (2) entitled ‘‘Substantial Equivalence consumer product. Nevertheless, FDA
the scientific evidence does not Reports: Manufacturer Requests for must regulate tobacco products in
demonstrate substantial reduction in Extensions or to Change the Predicate accordance with the Tobacco Control
harm to an individual from e-cigarette Tobacco Product’’ (79 FR 41292, July 15, Act, including section 910 of the FD&C
use if the consumer dual uses with 2014), and FDA guidance entitled Act, which states that in reviewing
cigarettes, except when dual use is a ‘‘Establishing That a Tobacco Product PMTAs for new tobacco products, FDA
short-term pathway to quitting smoking Was Commercially Marketed in the must consider whether the marketing of
cigarettes. United States as of February 15, 2007,’’ such product is appropriate for the
(Response) Section 910(b) of the among others. FDA also has issued a protection of the public health, and that
FD&C Act lays out the specific elements draft guidance entitled ‘‘Applications this finding is to be determined with
to be submitted in a PMTA and for Premarket Review of New Tobacco respect to the risks and benefits to the
910(c)(2)(A) specifies that FDA cannot Products’’ (76 FR 60055, September 28, population as a whole, including users
authorize the marketing of a product 2011). In addition, elsewhere in this and nonusers of the product, taking into
where there is a lack of showing that the issue of the Federal Register, FDA has account—the increased or decreased
marketing of a new tobacco product is made available draft guidance, which likelihood that existing users of tobacco
‘‘appropriate for the protection of the when final will describe FDA’s current products will stop using such products;
public health.’’ The FD&C Act states thinking on some appropriate means of and the increased or decreased
that this finding will be determined, addressing the premarket authorization likelihood that those who do not use
when appropriate, on the basis of well- requirements for newly deemed ENDS tobacco products will start using such
controlled investigations (section products. If FDA determines that products (section 910(c)(4) of the FD&C
910(c)(5)(A)). However, section additional guidance is necessary to help Act). This public health standard
910(c)(5)(B) of the FD&C Act also allows manufacturers prepare marketing requires the Agency to consider the
the Agency to consider other ‘‘valid applications, FDA will issue additional impact of the products on the
scientific evidence’’ if found sufficient guidance and publish a notice of ‘‘population as a whole,’’ not simply the
to evaluate the tobacco product. Thus, if availability in the Federal Register. adult population that may be using such
an application includes, for example, (Comment 43) One comment stated products.
information (e.g., published literature, that, because there is a lack of scientific (Comment 45) Some comments stated
marketing information) with appropriate evidence to show the health impact of that FDA regulations should support
bridging studies, FDA will review that vapor products, applying the premarket manufacturers’ efforts to invest in
information to determine whether it is requirements to this category of alternative tobacco products with the
valid scientific evidence sufficient to products is premature. Therefore, the potential to reduce harm.
demonstrate that a product is comment suggested that FDA exercise (Response) The Agency continues to
appropriate for the protection of the enforcement discretion to delay support development of alternative
public health. If an applicant has implementation of this requirement tobacco products with the potential to
questions or other alternatives to well- until more evidence is available. reduce harm, and believes that the
controlled investigations it would like (Response) FDA has established a PMTA, MRTP, and other regulatory
to utilize, we recommend that the compliance policy regarding the provisions will help foster the
applicant meet with FDA to discuss the premarket review requirements. This is development of tobacco products that
approach prior to preparing and described in section V.A. As discussed pose less risk to human health. In
submitting an application (see FDA elsewhere in this document, we believe addition, as a practical effect of the
guidance ‘‘Meetings with Industry and the compliance period is appropriate, Agency’s compliance policy for
Investigators on the Research and and it takes into account the time for premarket review of newly deemed
Development of Tobacco Products’’). In firms to generate and submit the tobacco products, FDA expects that
addition, elsewhere in this issue of the information for a PMTA. The many manufacturers, including those
Federal Register, FDA has made requirements and costs of a PMTA may with alternative tobacco products, will
available ENDS PMTA draft guidance vary based on the type and complexity continue to market their products
which, when final, will describe FDA’s of the product. For example, where during preparation of submissions and
current thinking regarding some there is limited understanding of a for the continued compliance period
appropriate means of addressing the product’s potential impact on public afterward. The time it takes to review
premarket authorization requirements health, nonclinical and clinical studies premarket applications is dependent
for newly deemed ENDS products. may be required for market upon the type of application and the
(Comment 42) Given the differences authorization. In such case, the complexity of the product.
among newly deemed product requirements and cost of the PMTA
categories and the potential benefits likely would be higher (and the review G. Other Comments
from these products, some comments time longer) than for a product in which (Comment 46) A few comments
said that FDA should develop clear there is already substantial scientific suggested that FDA review and
guidance regarding the scientific data on the potential public health authorize marketing of products at the
evidence the Agency will need to impact. This information provided as ingredient level. For example, if a
review the safety and health impact of part of premarket review (design, tobacco product contained only
these products and to accelerate the ingredients, levels of HPHCs) will preauthorized ingredients, the product
review of marketing applications where provide critical information on these could be marketed, possibly through
necessary. products. self-certification. If the product used
(Response) To help provide clarity (Comment 44) One comment unapproved ingredients, the
regarding submission requirements for suggested that FDA regulate e-cigarettes manufacturer would be required to
submit a PMTA containing information The Agency recommends that on publically available information, that
on only those ingredients or meet manufacturers consult with CTP’s OS the number of entities engaged in
established testing guidelines. The about what is appropriate in the context upstream production of liquid nicotine
comments suggested that standards that of a specific application. and flavors specifically developed for
could be used to assess the ingredients FDA recognizes, however, that it use with e-liquids is in the range of
may include the U.S. Pharmacopeial could be difficult for certain seven to thirteen entities (see earlier
Convention (USP), FDA’s Generally manufacturers of the newly deemed discussion in response to comment 34).
Recognized as Safe (GRAS) standards, products (e.g., small businesses) to Given the nature of the marketplace,
the New Drug Products Q3B(R2) comply with the section 904 HPHC FDA expects that the master file system
guidance; and the Food Chemicals requirements for all of their currently will be widely appealing and widely
Codex or FDA Redbook of Foods. marketed products. For example, utilized by the ENDS industry.
(Response) FDA disagrees. Section contract laboratories may not be (Comment 48) Several comments
910 of the FD&C Act requires FDA to prepared for the large volume of noted that large numbers of tobacco
evaluate the new tobacco product as a requests for the testing of quantities of product manufacturers waited until
whole to determine whether the the HPHCs for all brands and subbrands March 22, 2011 (the date that
authorization of marketing of the of tobacco products marketed prior to provisional SE reports were due for the
product is appropriate for the protection the effective date. Thus, we have original tobacco products subject to the
of the public health. In addition, we established a compliance period of 3 FD&C Act) to submit their SE reports.
note that GRAS status for a food years for submission of this data under They considered this an abuse of the
additive does not mean that the section 904 for products on the market process and expressed concern that
substance is GRAS when inhaled, since as of the effective date. In addition, in manufacturers of newly deemed
GRAS status does not take inhalation the context of all newly deemed products would act similarly,
toxicity into account and applies only to products considered in total, many particularly with a 24-month
intended uses that may reasonably be products may be grandfathered and will compliance period. They suggested that
expected to result, directly or indirectly, thus not be required to obtain premarket FDA expressly require companies to
in its becoming a component or authorization through one of three meet all other requirements, including
otherwise affecting the characteristics of pathways—SE, exemption from SE, or ingredient reporting and quality
any food (section 201(s) of the FD&C premarket tobacco product applications controls, to be able to avail themselves
Act.). (sections 905 and 910 of the FD&C Act). of this extended compliance period.
(Comment 47) A few comments Given that the number of newly deemed Other comments stated that any
expressed concern as to the products in total seeking PMTA orders compliance period should be contingent
contemplated compliance periods for likely will be much smaller than the on FDA issuing orders on all pending
HPHC testing (with a proposed total number of such tobacco products SE reports already submitted to the
compliance period of 3 years following on the market as of the effective date Agency.
the effective date of the final rule) and (given that many products will be (Response) FDA understands
the contemplated 24-month compliance grandfathered and that some products concerns about the Agency’s timely
period for marketing applications, may exit without submission of an review of applications given the influx
because applicants will need to submit application), FDA expects that the of SE reports that FDA received at the
HPHC data with their PMTAs. They HPHC information submitted as part of close of the SE provisional period
requested that FDA delay its these PMTA applications can be (March 22, 2011). However, FDA has
enforcement of PMTA and SE obtained within the 2-year submission taken several steps to address the
application requirements until it has period for newly deemed tobacco resulting backlog and to provide helpful
established an HPHC list and validated products. (FDA notes that the feedback to industry to encourage more
methodology for individual products. proportion of products that may qualify complete, streamlined submissions and
(Response) While applicants should as grandfathered is likely to vary for reviews, including: (1) Encouraging
submit certain information about different product categories. For teleconferences between the assigned
HPHCs as part of their applications, the example, the ENDS product category, regulatory health project manager and
requirement to submit HPHC listings for which the market has changed the applicant; (2) streamlining the SE
under section 904 of the FD&C Act (21 dramatically since 2007, is likely to report review process by modifying the
U.S.C. 387d) is separate and distinct have a smaller proportion of preliminary review so that it focuses
from the premarket review requirements grandfathered products than some other only on administrative issues and
under section 910. HPHC information product categories.) allowing submission deficiencies to be
submitted under section 904 will assist Moreover, elsewhere in this issue of communicated to the applicant more
FDA in assessing potential health risks the Federal Register, FDA has made quickly; (3) providing information on
and determining if future regulations to available a final guidance to provide FDA’s Web site about the three
address a product’s health risks are information on how to establish and pathways available to market products
warranted. For PMTAs, FDA expects reference a Tobacco Product Master File (including SE) and developing public
that applicants will report the levels of (TPMF). FDA notes that we expect Webinars to explain the Agency’s
HPHCs as appropriate for each product, reliance, to the extent applicable, on processes; and (4) publishing guidance
so the reported HPHCs will differ among TPMFs to increase efficiency and reduce documents. On March 24, 2014, FDA
different product categories. Elsewhere any burdens on manufacturers. As announced that the Agency no longer
in this issue of the Federal Register, discussed in section IX, because of the has a backlog of regular SE reports
FDA has made available draft guidance, nature of upstream supply of many awaiting review. The Agency is now
which when final will describe FDA’s components for ENDS products, reviewing regular SE reports as they are
current thinking regarding some especially e-liquids, FDA anticipates received. FDA expects that these steps
appropriate means of addressing the that commercial incentives will be will help reduce the time it will take
premarket authorization requirements sufficient to drive manufacturer reliance FDA to review submissions for newly
for newly deemed ENDS products, on the system of master files. We note deemed products. In addition, FDA has
including information regarding HPHCs. that, at present, FDA understands, based specified end dates for the compliance
periods for such products, after which premarket review also will increase (Response) FDA recognizes that
such products on the market without product consistency. For example, certain retailers may need more than 30
authorization (even if applications FDA’s oversight of the constituents of e- days to begin compliance with the
submitted during the relevant cigarette and other ENDS cartridges will youth access and vending machine
compliance periods are still under help to ensure quality control relative to restrictions included in this rule. For
review) will be subject to enforcement. the chemicals and their quantities being example, ENDS retail establishments or
We note that these staggered compliance aerosolized and inhaled. At present, cigar retailers that have not previously
dates will help to manage the flow of there is significant variability in the been subject to similar restrictions for
applications into FDA. If an applicant concentration of chemicals among some cigarettes and smokeless tobacco may
wishes to discuss a product application, products—including variability between need additional time to implement these
the applicant may request a meeting as labeled content and concentration and regulations. To address these situations,
set forth in FDA’s final guidance actual content and concentration (see FDA is establishing a 90-day effective
entitled ‘‘Meetings with Industry and section VIII.D). Without a regulatory date for this deeming provision and the
Investigators on the Research and framework, users will be subject to accompanying automatic provisions in
Development of Tobacco Products’’ significant variability among products, the FD&C Act, as well as the minimum
(announced May 25, 2012, 77 FR raising potential public health and age and identification requirements and
31368). safety issues. vending machine restrictions. FDA does
(Comment 49) At least one comment not believe that a 6-month compliance
suggested that FDA should require IV. Implementation
period is necessary to educate retailers
manufacturers that have not received FDA’s proposal stated that part 1100, on these requirements given that many
their marketing authorizations within 1 deeming additional tobacco products to retailers also sell products that are
year after the effective date of the final be subject to chapter IX of the FD&C currently subject to Federal and/or State
deeming to include a statement on their Act, and the minimum age and and local regulations regarding
packaging and labeling indicating that identification and vending machine minimum age and identification.
the product is pending FDA evaluation restrictions in part 1140 would be (Comment 52) Some comments
under the Tobacco Control Act. effective 30 days after publication of the suggested that FDA delay the effective
(Response) FDA declines to issue final rule and listed compliance periods dates of all deeming provisions until the
such a labeling requirement at this time. for different requirements. FDA received Agency can issue product standards
We do not have evidence that the many comments regarding the proposed (under section 907) and good
statement will be appropriate for the effective date, compliance periods, and manufacturing practice regulations
protection of the public health, as other enforcement issues. A summary of (under section 906(e)), as these are the
determined with respect to the risks and these comments and FDA’s responses most important requirements for the
benefits to the population as a whole are included as follows. newly deemed products. They stated,
(which is the standard for such a however, that all rulemaking on e-
A. Effective Date for Rule
requirement under section 906(d) of the cigarettes should be delayed until the
FD&C Act). FDA also is concerned about FDA proposed that part 1100, science is firmly established to allow for
consumer confusion or misconceptions deeming products to be subject to the more informed FDA decisionmaking.
that could result from such a chapter IX automatic provisions, and (Response) FDA disagrees. As we
requirement. the minimum age and identification and have stated throughout the document,
(Comment 50) At least one comment vending machine restrictions in part FDA has data regarding health harms
suggested that application of premarket 1140 be effective 30 days from the generally associated with all of the
review requirements to the newly publication date of the final rule. Based categories of tobacco products regulated
deemed products (namely, e-cigarettes) on our review of comments, FDA is under this rule (including ENDS). FDA
is unnecessary, because the benefits that finalizing this rule so that the automatic is regulating these products in
would accrue as a result of deeming are provisions, minimum age provisions, accordance with this knowledge. We
independent of the premarket review and vending machine restrictions will will continue to build upon our
provisions. be effective 90 days from the date of the product-specific knowledge through the
(Response) FDA disagrees. The final rule’s publication, as explained in information we receive as a result of the
premarket provisions of the statute this document. The compliance periods application of the FD&C Act’s automatic
apply automatically to deemed for other sections are discussed in this provisions, such as ingredient reporting
products. While FDA outlined in the section. and the reporting of HPHCs, to newly
NPRM a number of public health (Comment 51) A few comments deemed tobacco products. In addition,
benefits that would accrue as a result of expressed concern regarding the as discussed in the NPRM, FDA believes
deeming products subject to chapter IX effective date of the deeming provisions that many public health benefits will
as a whole (79 FR 23142 at 23148 and in part 1100, which is also the effective accrue as a result of deeming these
23149), as explained in this document, date of the minimum age and products (79 FR 23142 at 23148 and
FDA believes that the public health identification regulations. They stated 23149). It would not protect the public
benefits that will accrue from the that a 30-day effective date for the health to forego implementation of these
premarket review provisions are minimum age and identification provisions until FDA can issue final
substantial. Implementation of these regulations provides too small a product standards and tobacco product
provisions will allow FDA to monitor window of time for retailers to adjust manufacturing practice regulations. It is
product development and to prevent employee training curricula, train and also important to note that this final
potentially more harmful or addictive educate employees, raise awareness of deeming rule is a foundational rule that
products from reaching the market. the new requirements, and adjust in- enables FDA to issue future regulations
Premarket review is especially critical store or point-of-sale job aids to ensure if FDA determines that they would be
given the changing nature of the ENDS compliance. These comments requested appropriate for the protection of public
technology and industry and the a 6-month compliance period for both health.
increasing interest in these products the youth access and vending machine (Comment 53) Comments stated the
from youth and young adults. FDA’s provisions. NPRM is a ‘‘major rule’’ according to the
Office of Information and Regulatory appropriate and meet the applicable does not intend to enforce the reporting
Affairs, 5 U.S.C. 804(2) (1996), and the standard in section 906(d), FDA will requirements under section 904(a)(3) for
Congressional Review Act mandates follow the requirements of the APA to newly deemed products before the close
that the rule cannot take effect until 60 implement such restrictions. of the 3-year compliance period, even if
days after the final rule is published in With respect to compliance periods, the HPHC guidance is issued well in
the Federal Register (5 U.S.C. 801(a)(3) FDA is providing different compliance advance of that time. In addition, at this
(1996)). Therefore, they requested that periods for certain automatic time, FDA also does not intend to
FDA change the effective date for this requirements of the FD&C Act that are enforce this requirement in relation to
rule and the compliance periods for generally similar to the timeframes manufacturers of components and parts
parts 1100 and 1140 to at least 60 days provided in the statute for currently used for incorporation into finished
following publication of the final rule. regulated products to meet certain tobacco products. In this context, a
(Response) FDA is providing a 90-day requirements after the law’s date of finished tobacco product refers to a
effective date for parts 1100 and 1140 enactment. tobacco product, including all
with this final rule. components and parts, sealed in final
1. HPHC Reporting Requirements
B. Compliance Periods for Certain (Section 904) packaging intended for consumer use
Provisions (e.g., filters or filter tubes sold
As of the effective date of this rule, separately to consumers or as part of
To avoid confusion about existing the ingredient listing and HPHC kits). FDA considers an e-liquid to be a
dates in the FD&C Act that are based on reporting requirements of section 904 finished tobacco product if sold
the date of enactment of the law and to will apply to the newly deemed separately and not as part of an ENDS.
provide time for firms to comply with products. To provide manufacturers The Agency is committed to helping
provisions that require labeling changes sufficient time to comply with these industry better understand the tobacco
or information submissions to the requirements, FDA is providing product review process and the
Agency, FDA proposed compliance compliance periods for these requirements of the law and will
timeframes for certain provisions. The requirements as stated in table 3. continue holding public Webinars and
final compliance dates are included in (Comment 55) Most comments agreed meetings with industry. FDA has also
tables 2 and 3. with the compliance timeframes published guidance on meetings with
(Comment 54) Comments requested included in table 1B of the NPRM, aside industry; this has enabled FDA to have
that FDA impose the same requirements from the HPHC requirements under many productive meetings to address
on the newly deemed products that section 904(a)(3) (79 FR 23142 at 23172 companies’ specific questions on their
apply to currently regulated products, through 23174). They argued that the development of tobacco products. In
including the same compliance periods compliance period for testing and listing addition, FDA intends to issue guidance
for all provisions and the same of HPHCs was not sufficient for several regarding HPHC reporting, and later a
marketing and advertising restrictions. reasons, including: The costs associated testing and reporting regulation as
In addition, they stated that establishing with compliance; the lack of clear required by section 915, with enough
exemptions would create a significant product-specific guidance; and the lack time for manufacturers to report given
administrative burden for FDA, and that of available independent laboratories to the 3-year compliance period for HPHC
a single, comprehensive plan would be complete the testing for the many small reporting. As noted elsewhere in this
easier for industry to understand and for businesses that would be affected by the document, FDA does not intend to
the Agency to implement. requirements. enforce the reporting requirements
(Response) With this final rule, FDA (Response) The compliance period for under section 904(a)(3) for newly
is deeming additional tobacco products HPHC reporting under section 904(a)(3) deemed products before the close of the
subject to its chapter IX tobacco is the effective date of this rule plus 3 3-year compliance period, even if the
authorities. This means that newly years. FDA intends to issue guidance HPHC guidance is issued well in
deemed products will be subject to all regarding HPHC reporting, and later a advance of that time.
provisions in the FD&C Act applicable testing and reporting regulation as
to ‘‘tobacco products’’ in the same way required by section 915, with enough 2. Registration and Listing (Section 905)
that currently regulated tobacco time for manufacturers to report given As of the effective date of this rule,
products are also subject to those this compliance period. Section those persons who own or operate
provisions. Under section 901, FDA is 904(a)(3) requires the submission of a domestic manufacturing establishments
authorized to deem products subject to report listing all constituents, including engaged in manufacturing newly
‘‘chapter IX,’’ not to particular smoke constituents, identified as deemed tobacco products (including
provisions of chapter IX. Thus, there are harmful or potentially harmful (HPHC) those that engage in the blending of pipe
no exemptions from particular by the Secretary. Section 915 requires tobacco and the mixing of e-liquids as
requirements for any product category the testing and reporting of the discussed in section IX.C) will be
(although FDA is announcing constituents, ingredients, and additives required to register with FDA and
enforcement policies for certain the Secretary determines should be submit product listings under section
requirements and for small-scale tested to protect the public health. The 905. This deeming rule will not require
tobacco product manufacturers as section 915 testing and reporting foreign manufacturing establishments to
discussed throughout this document). requirements apply only after FDA register their establishments or to list
FDA is subjecting covered tobacco issues a regulation implementing that their tobacco products in order to sell
products to the additional provisions section, which it has not yet done. Until them in the United States. However,
(i.e., age and identification these testing and reporting requirements foreign manufacturing establishments
requirements, vending machine have been established, newly deemed will be required to comply with the
restrictions, and health warning tobacco products (and currently registration and listing requirements of
requirements) discussed in this final regulated tobacco products) are not section 905 of the FD&C Act after a
rule. If FDA later determines that further subject to the testing and reporting registration and listing rule is final and
marketing and advertising restrictions provisions found under section 915. As effective. Because the compliance
for newly deemed products are noted elsewhere in this document, FDA period for registration and listing
depends on the date of publication of and to CTP’s Office of Small Business on labeling, labels, or advertising
this final rule, FDA intends to revise the Assistance, which is part of OCE. (unless an order was issued authorizing
current guidance (‘‘Registration and Further, section 905 of the FD&C Act their marketing) took effect 12 months
Product Listing for Owners and requires FDA to issue a rule through the after the date of enactment of the
Operators of Domestic Tobacco Product notice and comment rulemaking process Tobacco Control Act, and manufacturers
Establishments’’), which FDA expects to in order to apply the registration and also had an additional 30 days after the
issue within six months following the product listing requirements to foreign effective date to continue to introduce
effective date of the final deeming rule, manufacturers—the requirements for these products with these descriptors
to clarify the compliance periods for domestic manufacturers are into domestic commerce. Additionally,
manufacturers of newly deemed tobacco immediately implemented and do not this compliance policy balances the
products. require a regulation. (Section 905(h) of need to help consumers better
(Comment 56) Most of those the FD&C Act.) FDA has announced its understand and appreciate the health
comments regarding the registration and intent to issue a rule regarding risks of these newly deemed tobacco
listing requirements stated that the registration and listing, including products while providing manufacturers
contemplated compliance period was application of the requirements to with sufficient time to revise the label,
sufficient, because these requirements foreign manufacturers, in the Unified labeling, and advertising as appropriate.
are not costly or time-consuming for Agenda (RIN No. 0910–AG89). This compliance policy does not
manufacturers, provided FDA’s extend to other MRTPs as defined in the
3. Modified Risk (Section 911)
electronic submission system is working remaining sections of 911(b) (e.g.,
effectively. A minority of comments As of the effective date of this rule, tobacco products of which the label,
asked for a longer compliance period section 911 will automatically apply to labeling, or advertising explicitly or
that would be based on FDA published the newly deemed products. Among implicitly represents that the product
guidance for individual product other requirements, this section presents a lower risk of tobacco-related
categories that includes examples of prohibits the introduction or delivery disease or is less harmful than one or
completed registration and listing forms. for introduction into interstate more other commercially marketed
Most of the comments also stated that commerce of MRTPs, including those tobacco products, the product or its
foreign and domestic companies should with certain specified descriptors smoke contains a reduced level/presents
be required to comply with registration (‘‘light,’’ ‘‘low,’’ ‘‘mild,’’ or similar a reduced exposure to a substance, or
and listing requirements at the same descriptors) in the label, labeling, and the product or its smoke does not
time to ensure fair and equal treatment advertising of such products, unless contain/is free of a substance; or action
among each product category. They manufacturers submit a MRTP taken by a manufacturer directed to
stated that this was especially important application and receive FDA consumers through media or otherwise,
given that many of the novel products authorization before marketing. The other than through the product’s label,
are manufactured outside the United basic requirement for premarket review labeling, or advertising that would be
States and that comprehensive of MRTPs will apply immediately upon reasonably expected to result in
registration requirements will promote the effective date. To provide consumers believing that the tobacco
equitable assessment and collection of manufacturers sufficient time to comply product or its smoke may present a
user fees. with the prohibition on products with lower risk of disease or is less harmful
(Response) FDA agrees with specified descriptors, FDA is providing than one or more commercially
comments stating that the contemplated a compliance period for this marketed tobacco products, or presents
compliance period for registration and requirement, as stated in table 3. a reduced level/exposure to
listing is sufficient. To provide (Comment 57) The comments substance(s), or does not contain/is free
additional assistance to newly deemed generally stated the 1-year compliance of a substance(s)). Just as these
product manufacturers, FDA intends to period for section 911(b)(2)(A)(ii) was provisions took effect immediately upon
provide examples of completed sufficient, but some stated that it was the enactment of the Tobacco Control
registration and listing forms for each unnecessary for FDA to provide any Act for currently regulated products,
major category of newly deemed compliance period and that newly deemed products will be
products at least 6 months before the manufacturers should begin complying expected to comply with these
end of the compliance period. In with these provisions upon the final provisions on the effective date of part
addition, in 2013, CTP adopted a new rule’s effective date. 1100. The agency believes this is
electronic system, FDA Unified (Response) FDA believes that the 12- necessary in order to ensure that
Registration and Listing System month period to comply with the consumers better understand and
(FURLS), with capacity to accept restrictions set forth in section appreciate the health risks of newly
registration and listing submissions for 911(b)(2)(A)(ii) (after which a deemed products, particularly where a
all FDA-regulated products, which has manufacturer may not manufacture, product’s label, labeling, or advertising
and will continue to simplify the without an order in the effect, any makes express or implied claims of
process of submitting registration and tobacco product which contains ‘‘light,’’ reduced risk or less harm or that a
listing information, making it more ‘‘low,’’ or ‘‘mild,’’ or similar descriptors product has reduced levels of or is free
efficient for industry and providing on label, labeling, or advertising), and of a substance(s).
faster access to this information by both the additional 30-day period where
FDA and industry. Unlike the previous manufacturers may continue to 4. Required Warnings
eSubmitter process, FURLS is an online distribute products into domestic (Comment 58) A few comments
application that allows users to access commerce, are consistent with the suggested that manufacturers should be
multiple databases simply by going to effective dates originally included in the required to implement the proposed
the FURLS Web site and viewing and Tobacco Control Act. Under section health warnings within 6 months
updating their data at any time. 911(b)(3), the prohibition on the following the effective date of this rule.
Questions regarding registration and manufacture and distribution of tobacco One comment stated that the health
listing requirements can be directed to products containing ‘‘light,’’ ‘‘low,’’ or warnings should take effect no later
CTP’s call center at 1–877–CTP–1373 ‘‘mild,’’ or similar descriptors appearing than 12 months from publication of the
final rule. They stated that the delay in the proposed effective date of 24 months enforce compliance with the regulation.
implementing the health warnings has after publication of this rule for the We note that the compliance periods
the potential to continue to foster the warning requirements in part 1143 is and provisions for sections 904(a)(3)
perception, particularly on the part of appropriate. and 904(a)(4) have been consistent with
youth, that e-cigarettes are safe products FDA’s approach for currently marketed
5. Compliance Period Tables
and the misunderstanding that they tobacco products and FDA’s final
have been found to be safe and effective The final compliance period table for guidance entitled ‘‘Tobacco Health
cessation products. They also stated that various provisions is included in this Document Submission’’ (75 FR 20606,
the shorter compliance period is document. (The compliance policy for April 20, 2010). In addition, FDA has
necessary to quickly make consumers submission of premarketing revised the compliance period for
aware of the possibility of becoming applications is discussed in section section 903(a)(8) of the FD&C Act from
addicted to e-cigarettes. V.A.) To clarify, effective dates differ ‘‘effective date of part 1100 PLUS 1
(Response) FDA has considered the from compliance periods. While a year’’ to ‘‘24 months after the
comments and the time and resources it requirement is effective on a certain publication of this final regulation’’ so
will take for manufacturers to comply date (here, the ‘‘effective date’’), for that it is consistent with the effective
with the health warnings requirements many provisions, FDA is providing a dates for the health warning
and the need to provide these messages compliance period with additional time requirements in part 1143 of this final
to consumers and has determined that during which FDA does not intend to rule.
TABLE 2—COMPLIANCE WITH VARIOUS AUTOMATIC PROVISIONS

FD&C Act citation Compliance period
902(1)–(5), (8) .......................................................................................... Effective date of part 1100.

903(a)(1) ................................................................................................... Effective date of part 1100.
903(a)(6)–(7) ............................................................................................. Effective date of part 1100.
904(c)(2), (3) ............................................................................................. Effective date of part 1100.
905(i)(3) .................................................................................................... Effective date of part 1100.
911(a), 911(b) [with the exception of products sold or distributed using Effective date of part 1100.
the descriptors set forth in 911(b)(2)(A)(ii)].
919(a) ....................................................................................................... See FDA’s final rule revising the current user fee regulations published
concurrently with this final deeming rule.
TABLE 3—COMPLIANCE PERIODS FOR OTHER PROVISIONS

FD&C Act citation Compliance period
903(a)(2) .................................................... 24 months after the publication of this final regulation.

* This is designed to match the 24 month effective date of the health warnings.
903(a)(3) .................................................... Effective date of part 1100 PLUS 1 year.
* This is designed to match the 1 year deadline in the FD&C Act for currently regulated products.
904(a)(1), 904(c)(1) ................................... Effective date of part 1100 PLUS 6 months (products on the market as of the effective date) or 90
days before delivery for introduction into interstate commerce (products entering the market after
the effective date).
* This matches the timeframes provided in this section.
904(a)(3) .................................................... Effective date of part 1100 PLUS 3 years or, for products delivered for introduction into interstate
commerce later than 3 years after the effective date, 90 days before delivery for introduction into
interstate commerce (products entering the market after the effective date).
904(a)(4) .................................................... Effective date of part 1100 PLUS 6 months.
905(b), (c), (d), (h) ..................................... If the final rule publishes in the second half of the calendar year, FDA intends to issue a compliance
policy with a compliance period for registration that is no later than 6 months into the subsequent
calendar year.
905(i)(1) ..................................................... Same compliance period as that for initial registration; see date specified for 905(b).
907(a)(1)(B) ............................................... Effective date of part 1100 PLUS 2 years.
* This matches the timeframe provided in this section.
911(a), (b)(1), (b)(2)(A)(ii), (b)(3) ............... Use of ‘‘light,’’ ‘‘low,’’ and ‘‘mild’’ descriptors: Effective date of part 1100 PLUS 1 year (stop manu-
facture);
Effective date of part 1100 PLUS 13 months (stop distribution).

6. Other Enforcement Issues exists for premium Cuban cigars. The containing ENDS products for sale or
(Comment 59) A few comments comments also noted that those importation in the country a 2015 e-
expressed concern that this rule will involved in the waterpipe tobacco cigarette usage study (Ref. 48) showed
result in the growth of an illicit market industry already operate more usage rates among Canadian
for certain newly deemed tobacco informally (e.g., without local populations that were similar to those
products, particularly e-cigarettes and e- regulation) and, therefore, the deeming among U.S. populations.
regulation would cause more business Despite the potential for some illicit
liquids. They suggested that such an
to be transacted in illicit markets. They ENDS market activity to occur, FDA
illicit market could make products more
also expressed concern about the emphasizes that the presence of an
available and more attractive to youth
development of a flourishing illicit illicit market does not affect its legal
and young adults. They also feared that
market if flavors were not permitted in authority to regulate such products and
this illicit market would worsen if FDA
the deemed products. that there is evidence that many ENDS
were to ban certain e-liquid flavorings,
(Response) FDA understands these manufacturers will likely submit
stating that the deeming rule (and/or a
concerns, but believes that this rule will premarket applications in the United
ban on certain flavorings) would result States.
in consumers mixing their own e- not increase current illicit practices or
create new illicit markets, because FDA Moreover, as stated previously, FDA
liquids, even though the comments expects that the public health benefits
stated that most consumers are not is not banning any tobacco product with
this deeming rule. Even if some illicit that likely will accrue as a result of this
adept at handling or mixing chemicals. final rule will be greater than the
These ‘‘do-it-yourself manufacturers,’’ trade were to develop in an attempt to
evade the requirements of this rule, FDA negative effects that could result if there
as the comments referred to them, were an increase in illicit markets. This
would increase health risks, because does not believe it would result in a
volume sufficient to outweigh the final deeming rule will afford FDA
more individuals possessing pure additional tools to reduce the number of
nicotine could lead to more accidental public health benefits of the rule. FDA
authority over the newly deemed illnesses and premature deaths
poisonings and the possibility of associated with tobacco product use.
overdoses. Comments pointed to a tobacco products will give it means to
determine which products are legally on For example, FDA will be able to obtain
survey from an e-cigarette forum which critical information regarding the health
stated that ‘‘[a]bout 79 percent of the market and which are counterfeit or
otherwise illegally marketed. The risks of newly deemed tobacco
respondents said they would ’look to products, including information derived
the black market’ if products they use Tobacco Control Act gives the Agency
these and other authorities, such as from ingredient listing submissions and
’were banned tomorrow,’ while 14 reporting of HPHCs required under the
percent said they would return to section 920 of the FD&C Act (21 U.S.C.
387t), to help address illicit tobacco FD&C Act. FDA will also receive
smoking analog cigarettes’’ (e.g., Ref. information on the location and number
44). products.
In addition, FDA recently of manufacturing establishments, which
Comments also expressed concern will allow the Agency to establish
commissioned a report from the
that regulation will increase prices of effective compliance programs. In
National Research Council and Institute
the newly deemed tobacco products and addition, because of this rule, FDA will
of Medicine Panel to help us better
consumers will turn to an illicit market be able to take enforcement action
understand and consider all aspects of
to obtain products for lower prices. For against manufacturers of newly deemed
illicit tobacco markets (Ref. 46). This
example, they stated that some markets products who make unsubstantiated
report focused mainly on combustible
for cigarettes (e.g., New York) MRTP claims or false or misleading
products, especially cigarettes, as they
experience smuggling rates of beyond 50 claims about their products, thus
are the subject of most illicit tobacco
percent, as consumers seek products for allowing for better-informed consumers
trade. The relevance of those findings to
lower costs. These comments expected and helping to prevent the use of
an assessment of the potential for illicit
a similar result to occur after the misleading campaigns targeted to youth
trade in tobacco products more
deeming rule becomes effective (see Ref. populations. It will also prevent from
generally in the United States, such as
45). entering the market new products that
Further, they stated that this illicit ENDS products, is open to question.
are not appropriate for the protection of
market would cause additional Overall, illicit trade in cigarettes is
public health, are not substantially
problems like stifling innovation for under 10 percent. It is not clear if illicit
equivalent to a valid predicate product,
regulated companies, because trade in any of the newly deemed
or are not exempt from SE. Finally, the
companies operating in the illicit products will be greater or less than that
newly deemed tobacco products may be
market would not be complying with observed for cigarettes. Evidence from
subject to future regulations that FDA
costly regulations and would be able to Canada shows the development of an
determines are appropriate.
take advantage of innovations elsewhere illicit market in ENDS products in that FDA believes that this rule will not
in the world. They theorized that this particular context where the stifle innovation but could, instead,
illicit market would favor very small government currently regulates all encourage it. The greater regulatory
domestic producers over existing nicotine-containing electronic smoking certainty created by the premarket
medium-sized domestic manufacturers products as medical devices under the review process may encourage
with better quality control and safety Food and Drugs Act, regardless of the companies to invest in creating
mechanisms. products’ health claims.12 Canada does, potentially beneficial novel products,
In addition to concerns about e- however, have a legal market for the sale with greater confidence that improved
cigarettes, comments expressed of non-nicotine containing ENDS products will not be competing against
concerns about the potential for illicit products. Despite the fact that Health equally novel, but more dangerous,
markets for other newly deemed Canada has not approved any nicotine- products. For example, a company may
products. For example, they stated that 12 ENDS and e-liquids that do not contain
be more willing to invest the additional
a final deeming regulation (without an nicotine can be legally sold in Canada. Health
resources needed to ensure that its
exemption for premium cigars) would Canada issued a Notice in 2009 regarding electronic product is designed and manufactured
exacerbate the black market that already cigarette products that contain nicotine (Ref. 47). with appropriate methods and controls.
The PMTA pathway will incentivize FDA has provided guidance requirement with respect to all such
development of tobacco products that (‘‘Demonstrating the Substantial documents at this time, so long as a
pose less risk to human health by Equivalence of a New Tobacco Product: specified set of documents is submitted
limiting market access by riskier Responses to Frequently Asked by the effective date plus 6 months.
competitor products. Furthermore, since Questions (Edition 2)’’) on currently FDA intends to publish additional
the ‘‘appropriate for the protection of regulated tobacco products stating that a guidance that specifies the scope of
the public health’’ standard involves change in supplier, where the new such health documents within three to
comparison to the general tobacco supplier is used for the same ingredient, six months of the publication date of
product market, FDA believes that, over additive, component, part, or material, this final rule, with sufficient advance
time, the premarket authorities will with identical specifications, would not time for manufacturers and importers to
move the market toward less risky render a new tobacco product. This prepare their submissions.
tobacco products. guidance also will apply to newly FDA does intend to collect other
deemed products. tobacco health documents developed
C. Policy for Certain Regulatory after June 22, 2009, but before doing so
Requirements for All Manufacturers of 2. Reporting of HPHCs the Agency will publish additional
Newly Deemed Products FDA intends to issue guidance guidance specifying the timing of
FDA received many comments regarding HPHC reporting, and later a subsequent submissions. Note that,
expressing concern regarding the testing and reporting regulation as despite this compliance policy with
regulatory and financial burdens required by section 915, with enough respect to timeliness of submissions,
associated with certain automatic time for manufacturers to report given manufacturers and importers are still to
provisions that will apply to newly the 3-year compliance period for HPHC preserve all tobacco health documents
deemed products once this rule reporting. Section 904 (a)(3) requires the developed after June 22, 2009, for future
becomes effective. In response to submission of a report listing all submissions to FDA. Failure to submit
comments, FDA has considered constituents, including smoke tobacco health documents developed
instances in which the Agency has constituents, identified as harmful or after June 22, 2009, because of a failure
implemented compliance policies for potentially harmful (HPHC) by the to preserve them after publication of
currently regulated products. Secretary. Section 915 requires the this rule will constitute a violation of
Accordingly, the Agency is announcing testing and reporting of the constituents, section 904(a)(4).
the following compliance policy with ingredients, and additives the Secretary
respect to newly deemed products. As determines should be tested to protect 4. Compliance Policy for Components
with any such policy, the Agency will the public health. The section 915 and Parts
review and revise this policy as testing and reporting requirements As discussed in section VI.B, at this
appropriate. If FDA were to change this apply only after FDA issues a regulation time FDA does not intend to enforce
policy, the Agency would provide implementing that section, which it has certain requirements for components
notice to affected entities. not yet done. Until these testing and and parts of newly deemed products
reporting requirements have been that are sold or distributed for further
1. Substantial Equivalence manufacturing into finished tobacco
established, newly deemed tobacco
As provided in guidance for currently products (and currently regulated products.
regulated products (‘‘Demonstrating the tobacco products) are not subject to the
Substantial Equivalence of a New D. Compliance Policy Regarding Certain
testing and reporting provisions found Provisions and Small-Scale Tobacco
Tobacco Product: Responses to under section 915. As noted elsewhere
Frequently Asked Questions (Edition Product Manufacturers
in this document, FDA does not intend
2)’’ (80 FR 53810, September 8, 2015)), to enforce the reporting requirements In the NPRM, FDA requested
FDA does not intend to enforce against under section 904(a)(3) for newly comment on the ability of smaller
manufacturers who make tobacco deemed products before the close of the manufacturers of newly deemed tobacco
blending changes without a marketing 3-year compliance period, even if the products to fully comply with the
authorization if the tobacco blending guidance is issued well in advance of requirements of the FD&C Act and how
changes are intended to address the that time. At this time, FDA also does FDA might be able to address those
natural variation of tobacco (e.g., due to not intend to enforce this requirement concerns. Considering the comments
variation in growing conditions) in in relation to manufacturers of and FDA’s finite enforcement resources,
order to maintain a consistent product. components and parts used for the Agency’s view is that those
However, FDA does intend to enforce incorporation into finished tobacco resources may not be best used in
the premarket authorization products. In the future, we intend to immediately enforcing the provisions of
requirements for tobacco blending evaluate if there are additional this rule against certain manufacturers
changes that are intended to alter the constituents that are present in newly that are small-scale tobacco product
chemical or perception properties of the deemed products and should be manufacturers and that fail to comply
new product (e.g., nicotine level, pH, included in the HPHC list for reporting. with certain requirements of the FD&C
smoothness, harshness). FDA also intends to issue guidance to Act. Therefore, FDA generally intends to
FDA does not intend to take further refine the list of reportable grant small-scale tobacco manufacturers
enforcement action for at least 30 HPHCs based on product class. additional time to respond to SE
calendar days from the date the not deficiency letters and to not bring
substantially equivalent (NSE) order 3. Tobacco Health Document enforcement action against those small-
issues for those products that are in a Submission scale tobacco product manufacturers
retailer’s current inventory at a specific Although section 904(a)(4) sets out an who submit ingredient listings within
retail location on the date FDA issues ongoing requirement to submit tobacco 12 months of the effective date of this
the NSE order. This policy extends only health documents developed after June rule, and is granting small-scale tobacco
to tobacco products that are already in 22, 2009 (the date of enactment of the product manufacturers an additional
a retail store that offers the products for Tobacco Control Act), FDA generally six-month compliance period for the
sale directly to adult consumers. does not intend to enforce the tobacco health document submission
requirements. As with any such policy, 1. SE Extension Requests (Section 4. Assistance With Marketing
FDA will review and revise these 905(j)) Applications
policies as appropriate. If FDA were to As with manufacturers in general,
change these policies, FDA would do so Although information adequate to
make submissions should be available these small-scale tobacco manufacturers
consistent with its Good Guidance will also benefit from additional
Practices regulations. to all manufacturers, we expect small
manufacturers to have more difficulty in assistance with their marketing
For purposes of this compliance
putting this information together in an applications, including the designation
policy, FDA generally considers a
of a Regulatory Health Project Manager
‘‘small-scale tobacco product SE Report. FDA presently intends, for
so that they have a single point of
manufacturer’’ to be a manufacturer of the first 30 months following the
any regulated tobacco product that contact in CTP’s OS for questions about
effective date of this rule, to grant
employs 150 or fewer full-time their marketing applications. They will
extensions to small-scale tobacco
equivalent employees and has annual also have access to an appeals process
product manufacturers for SE reports
total revenues of $5,000,000 or less. in the event that FDA denies their
that need additional time to respond to marketing applications (of which one
FDA considers a manufacturer to SE deficiency letters. Extensions are not
include each entity that it controls, is small business has already taken
automatically granted. Requests will be advantage). Staff from CTP’s OCE also
controlled by, or is under common considered on a case-by-case basis. Any
control with. To help make FDA’s will assist small-scale tobacco product
extensions granted are likely to be manufacturers with identifying the
individual enforcement decisions more limited in time—for example, where a
efficient, a manufacturer may types of documents that may be used to
manufacturer normally might have 90 establish that their predicate products
voluntarily submit information days to respond to a deficiency letter,
regarding all relevant factors, including were on the market on February 15,
FDA will, for small-scale tobacco 2007. This may include several calls or
information regarding employment and product manufacturers, grant an
revenues. Interested manufacturers may correspondence with the manufacturer
additional 30 days for such a response. as it submits different documents to the
contact CTP’s call center at 1–877–CTP–
FDA encourages all small-scale tobacco Agency.
1373 for questions regarding this
product manufacturers, especially those
compliance policy. We note that FDA’s 5. Assistance in Navigating Other
with limited or no experience with the
thinking regarding ‘‘small-scale tobacco Regulatory Requirements
product manufacturer’’ differs from the SE pathway, to submit SE reports as
definition of ‘‘small tobacco product early as possible. FDA is not instituting CTP’s OCE will continue to assist
manufacturer’’ in section 900(16) of the a similar policy for extension requests small-scale tobacco product
FD&C Act. related to PMTAs (nor is it providing manufacturers in submitting rotational
FDA notes that our thinking regarding additional time for small-scale tobacco warning plans for FDA approval. These
what a ‘‘small-scale tobacco product product manufacturers to prepare plans provide the firm’s plan for how
manufacturer’’ is for purposes of this PMTAs) given the already-extended the required warnings will be displayed
policy is designed to align with the compliance period for PMTAs, which on the packaging and advertising for
nature of the specific relief provided. provides an additional 6 months to their product, as required by 21 CFR
That is, the relief provided (as described submit a PMTA, discussed in section 1143.5. This may include several calls
throughout this document) relates V.A. or correspondence with the small
generally to requirements for entities to business as it seeks approval from the
2. Tobacco Health Document Agency.
compile or report information. These
Submissions (Section 904(a)(4)) CTP also has a system to assist small
activities may require an investment of
employee time and/or financial To address concerns of small-scale businesses in navigating the regulatory
resources that is more challenging for tobacco product manufacturers requirements of FDA. For example, the
the smallest entities to achieve. For regarding the submission of certain Center has a Call Center that triages all
these reasons, the threshold takes note health documents, and in recognition of calls received from regulated industry.
of both employee resources (FTEs) and FDA’s current enforcement priorities, The Center’s Office of Small Business
financial resources (annual revenues), FDA, for an additional 6 months responds to hundreds of calls, emails
ensuring that those entities with the following the end of the generally and correspondences from small
most limited human and financial businesses every year to assist them in
applicable compliance period, intends
resources are uniquely considered in answering their specific questions on
not to bring enforcement action against
FDA’s decisions about enforcement of how to comply with the law.
those small-scale tobacco product
these provisions, precisely because the manufacturers who submit the required V. Premarket Review Requirements and
provisions may require resources not as information. Compliance Policy
readily available to these entities.
Further, as stated elsewhere in this 3. Ingredient Listing Submissions Section 910 of the FD&C Act requires
document, in formulating its thinking, (Section 904(a)(1)) FDA authorization in order to market a
FDA has considered all available data new tobacco product. As described
on employment, revenues, production FDA understands concerns that small- elsewhere, the FD&C Act contains three
volume and other details of operation scale tobacco product manufacturers pathways for obtaining premarket
for current manufacturers of newly may need additional time to comply authorization: SE exemptions, SE
deemed products. In addition, FDA with section 904(a)(1)’s requirement that reports, and PMTAs.
notes that its current approach reflects manufacturers submit ingredient lists. Tobacco products that were on the
a careful review of the potentially FDA presently intends not to bring market on February 15, 2007, are
unique interests of the smallest tobacco enforcement action against those small- grandfathered and do not require
product manufacturers as considered in scale tobacco product manufacturers premarket authorization. However, as
light of the Agency’s statutory who submit section 904(a)(1)’s required described throughout this preamble,
obligations regarding the protection of information within 12 months of the these products are subject to the other
public health. effective date of this final rule. requirements of the statute.
A. Compliance Policy for Premarket remaining on the market for failure to of a marketing order (Comment No.
Review Requirements have a premarket authorization order. FDA–2014–N–0189–79772.).
In the NPRM, FDA contemplated a The compliance periods are staggered They also stated that this approach
compliance period of 24 months to improve efficiency for both FDA and would allow manufacturers to continue
regulated entities given that the time it to market the newly deemed products in
following the effective date for
takes to prepare premarket applications ways that appeal to youth and to
submitting a premarket application (SE
is dependent upon the type of manipulate the content of these
exemption request, SE report, or
application and complexity of the products in uncontrolled ways for an
PMTA), with a continued compliance
product. FDA intends to act as indefinite period (id.). They urged FDA
period pending review of those
expeditiously as possible with respect to to forego its contemplated compliance
applications (79 FR 23142 at 23144). In
all new applications, while ensuring policy unless proper precautions are
essence, the products would remain on
that statutory standards are met. taken to limit the time period these
the market during this indefinite
Further, if at the time of the conclusion products are allowed to remain on the
compliance period until the agency
of the continued compliance period, the market pending FDA review and
rendered a decision on an application or authorization. In addition, they
applicant has provided the needed
the application was withdrawn. information and review of a pending expressed concern that manufacturers,
Agency compliance/enforcement
marketing application has made knowing that submission of an
policies are not subject to the
substantial progress toward completion, application will permit them to market
requirements that govern notice-and-
FDA may consider, on a case-by-case products for years, have incentive to
comment rulemaking. Prof’ls & Patients
basis, whether to defer enforcement of submit numerous applications
for Customized Care v. Shalala, 56 F.3d
the premarket authorization (regardless of how incomplete or
592 (5th Cir. 1995) (a compliance policy
requirements for a reasonable time deficient the applications).
guide is not a substantive rule and not period. A network of tobacco control policy
subject to APA’s notice-and-comment FDA’s revised compliance policy for and legal specialists also expressed
rulemaking); Takhar v. Kessler, 76 F.3d premarket review aims to balance the concern regarding the effect of
995, 1002 (9th Cir. 1996) (FDA public health concerns raised in the continued marketing of new tobacco
compliance policy guides were not comments, allow the Agency to more products that have not been reviewed
required to go through notice-and- efficiently manage the flow of incoming under the applicable public health
comment procedures). But because the applications, and encourage high- standards of the Tobacco Control Act
relevant time periods are of obvious quality premarket submissions from (Comment No. FDA–2014–N–0189–
interest, FDA laid out its anticipated applicants. 81044). This organization noted the
compliance policy in the NPRM, and for In accordance with the Tobacco thousands of provisional SE reports
similar reasons, is announcing its Control Act (sections 905 and 910 of the submitted in the last five days before the
revised compliance policy here in the FD&C Act), a new tobacco product may statutory deadline, where such
preamble to the final rule, rather than in be legally marketed only if FDA has applications pending FDA review are
a separate guidance document. authorized its marketing under one of ‘‘being used as placeholders that will
FDA has considered the comments the three premarket pathways described allow the tobacco industry to continue
and data submitted in response to the throughout this document. As a result of to introduce new products at will, rather
compliance policy in the NPRM. Some the compliance policy being announced, than following the proper legal
comments expressed concern about the we expect that manufacturers of certain procedures established by the Tobacco
extended availability of newly deemed, newly deemed, new tobacco products Control Act.’’ They proposed a staggered
new tobacco products without scientific will continue to market their products timeline to submit applications under
review. Others provided additional data without FDA authorization for certain the three marketing pathways and a
regarding youth and young adult use of time periods. definite time period in which FDA
flavored tobacco products. In addition, would no longer exercise enforcement
others comments discussed the 1. FDA’s Revised Compliance Policy Is
discretion with respect to premarket
potential public health benefits from the Informed by Comments Submitted in
review of these products, noting that
availability of certain flavored newly Response to the NPRM
such an approach would incentivize
deemed products (as discussed in FDA received many comments industry to generate high-quality,
section VIII.F). Taking the diverse responding to its detailed requests for complete applications within the initial
comments on these issues, as well as the comment on possible compliance compliance period.
uncertainty regarding the positive or approaches. 79 FR at 23175–77. Some In addition, two large organizations
negative impact on public health from comments expressed concern that the dedicated to the health of youth and
products like ENDS, into account, FDA compliance policy for premarket review young adults urged FDA not to
has decided to implement the described in the NPRM would permit implement a compliance period of any
compliance policy with staggered initial the continued marketing of tobacco length for products sold in
compliance periods based on the products that have not been reviewed characterizing flavors other than tobacco
expected complexity of the applications, under the public health standards of the or any covered tobacco products that
followed by continued compliance Tobacco Control Act. For example, use marketing practices known to
periods for FDA review, such that our comments jointly submitted by 24 appeal to children and youth (Comment
enforcement discretion will end twelve health and medical organizations stated No. FDA–2014–N–0189–67268;
months after each initial compliance that the contemplated 24-month Comment No. FDA–2014–N–0189–
period. Under the policy described here compliance period and indefinite period 79413.). Ranking minority members of
for the staggered compliance periods, of continued marketing during FDA’s the Energy and Commerce Committee,
and while FDA is conducting its review review included in the NPRM would Health Subcommittee, and Oversight
of marketing applications during the prolong the public’s exposure to and Investigations Subcommittee, U.S.
continued compliance period, the products that contain nicotine, a highly House of Representatives also called for
Agency does not intend to take addictive substance, and that do not a more protective compliance period
enforcement action against products meet the statutory standard for the grant than the one contemplated in the
NPRM, arguing that the proposed 81859; Comment No. FDA–2014–N– change itself and any supporting
compliance period ‘‘puts the nation’s 0189–10852). information demonstrating that the
youth at risk’’ (Comment No. FDA– In response to these comments, we change to the product is minor and an
2014–N–0189–80119). These comments, note that nicotine use in any form is of SE Report is not necessary. This is less
among others, all stressed the particular concern for youth and information than that likely required for
attractiveness of these newly deemed pregnant women. On the other hand, a PMTA. We expect this policy will also
tobacco products to youth and young some evidence suggests that ENDS may create a more manageable flow of
adults and the need for a more potentially promote transition away premarket applications for newly
restrictive compliance policy to ensure from combusted tobacco use among deemed products. FDA expects that this
that FDA limits the continued marketing some current users and it is possible staggering of deadlines also will benefit
of new tobacco products that have not that there could be a public health regulated industry, since it will allow
been reviewed under the public health benefit. See also section III.F for for greater efficiency of FDA review and
standards of the Tobacco Control Act. additional discussion of premarket incentivize higher quality applications,
Further, in response to FDA’s requests pathways and the continuum of which will reduce review times for all
for comments and data in the NPRM, nicotine-delivering products. Based on products. New products for which no
numerous comments included data, currently available scientific evidence, application has been submitted by 24
research, and personal stories regarding this revised compliance policy strikes months from the effective date of this
the impact of candy and fruit flavors in an appropriate balance among various, rule will no longer be subject to this
tobacco products, including their appeal often competing, considerations. compliance policy and will be subject to
to youth and young adults, youth 2. FDA Is Announcing a Revised enforcement.
perceptions of flavored tobacco Unless FDA has issued an order
Compliance Policy With Staggered
products, and their potential effect on denying or refusing to accept the
Timeframes and Continued Compliance
transition from combusted tobacco submission, products for which timely
Periods
product use (particularly, comments premarket submissions have been
In the interest of public health and submitted will be subject to a continued
noted, in the case of adults using taking into account the fact that there
flavored ENDS to attempt to switch compliance period for 12 months after
are products already on the market that the initial compliance period described
completely away from cigarette will now be subject to premarket
smoking). In addition, many comments previously. For such products, FDA
review, and in light of the does not intend to initiate enforcement
urged FDA to take immediate action considerations discussed in section 1 for failure to have premarket
regarding flavored tobacco products as a above, we have established the authorization during this continued
result of increasing prevalence of following compliance policy for newly compliance period, which is as follows:
flavored product use, and new data deemed tobacco products. For those SE Exemption Requests—24 months
show continued growth in youth and newly deemed products that were on from the effective date of this final rule
young adult usage of flavored tobacco the market on the effective date of this (12 months after the compliance period
products. final rule, but that were not on the for submission of such requests)
In deciding upon a compliance policy market on February 15, 2007, FDA is SE Reports—30 months from the
to announce with this final rule, FDA providing two compliance periods: One effective date of this final rule (12
considered all these comments and for submission and FDA receipt of months after the compliance period for
sought to balance the Agency’s concern applications and one for obtaining submission of such reports)
about the continued marketing of new premarket authorization. Although such PMTAs—36 months from the effective
tobacco products that have not been products are subject to the premarket date of this final rule (12 months after
reviewed by FDA, the potential harmful review requirements of the FD&C Act, the compliance period for submission of
impact of flavored tobacco products on FDA does not intend to initiate such requests).13
youth, and the possibility that some of enforcement action for failure to have Once the continued compliance
those products are playing a role in premarket authorization during the period ends, new tobacco products on
helping some tobacco users transition respective compliance periods. the market without authorization will be
away from what is likely the most The compliance period for subject to enforcement. FDA will act as
harmful form of nicotine delivery for an submission and FDA receipt of expeditiously as possible with respect to
individual user, combusted tobacco applications for newly deemed tobacco all new applications, while ensuring
products. FDA considered adopting the products under the three premarket that statutory standards are met. FDA
compliance policy as described in the pathways is as follows: expects that this revised compliance
preamble to the NPRM or a compliance SE Exemption Requests—12 months from policy will encourage the submission of
policy that would provide different the effective date of this final rule high quality applications. By providing
compliance periods for flavored and SE Reports—18 months from the effective a date in which the continued
non-flavored tobacco products. FDA date of this final rule compliance period ends, manufacturers
also considered providing different PMTAs—24 months from the effective date will have an incentive to submit a
compliance periods for different of this final rule complete application and respond
product categories. For example, certain FDA is adopting the staggered substantively and expeditiously to
industry comments urged FDA to timelines in this policy to account for questions raised during the review
stagger compliance dates for different the possibility that applicants may need process instead of an incomplete or
product categories, to delay compliance additional time to gather information for deficient application just to stay on the
until FDA publishes a final guidance for certain premarket submissions that may market indefinitely. This staggered
each product category and to provide require additional data. For example, if
ENDS manufacturers a lengthier a manufacturer plans to submit an SE 13 In addition, we note that any new tobacco
compliance period based on where they Exemption Request, the firm may only product that was not on the market on the effective
date of the rule (i.e., 90 days after the publication
purport to fit within the risk continuum need to identify the product, provide date) is not covered by this compliance policy and
for nicotine-delivering products (e.g., certification statements, and gather will be subject to enforcement if marketed without
Comment No. FDA–2014–N–0189– scientific information on the additive authorization after the effective date.
compliance policy also will provide upon the continuum of risk presented that manufacturers of the newly deemed
FDA with a more manageable flow of by nicotine-delivering products. Other products cannot argue that they did not
incoming applications to be reviewed, comments suggested that we extend the have adequate notice that they would
allowing the agency to more quickly PMTA compliance period to 5 years need to comply with premarket
make decisions on applications. following the effective date of the final requirements given that the Unified
FDA believes the staggered rule to give manufacturers sufficient Agenda entry for the deeming proposal
compliance periods will be sufficient for time to complete the required testing. published on July 7, 2011, and was
manufacturers to provide high quality (Response) FDA has already continually updated in subsequent
applications. To help provide clarity published for public comment draft Unified Agenda entries. They argued
regarding submission requirements for guidance for industry regarding the that establishing similar timeframes for
marketing applications, FDA has issued submission of PMTAs, which when the newly deemed products only
several guidance documents, and is final will represent FDA’s current benefits industry and is detrimental to
finalizing other guidance documents, thinking on this topic. In addition, the public health.
regarding the evidence needed for SE elsewhere in this issue of the Federal (Response) FDA has considered these
reports, including FDA draft guidance Register, FDA has made available draft comments and concludes that the
entitled ‘‘Substantial Equivalence guidance, which when final will staggered compliance periods included
Reports: Manufacturer Requests for describe FDA’s current thinking with this final rule are sufficient to
Extensions or to Change the Predicate regarding some appropriate means of allow manufacturers of previously
Tobacco Product’’ (79 FR 41292, July 15, addressing the premarket authorization unregulated tobacco products to submit
2014), and FDA guidance entitled requirements for newly deemed ENDS applications without unduly delaying
‘‘Establishing That a Tobacco Product products. FDA is committed to helping compliance. As stated elsewhere in this
Was Commercially Marketed in the industry better understand the tobacco document, FDA has taken several steps
United States as of February 15, 2007,’’ product premarket review process and to provide helpful feedback to industry
among others. FDA also has issued a will continue to hold public Webinars to encourage more complete,
draft guidance entitled ‘‘Applications and meetings with industry. FDA has streamlined submissions and reviews,
for Premarket Review of New Tobacco also published guidance on meetings including: (1) Encouraging
Products’’ (76 FR 60055, September 28, with industry, and FDA has had many teleconferences between the assigned
2011). In addition, elsewhere in this productive meetings to address regulatory health project manager and
issue of the Federal Register, FDA has companies’ specific questions on the the applicant; (2) streamlining the SE
made available draft guidance, which development of tobacco products. As report review process by modifying the
when final will describe FDA’s current FDA reviews product applications for preliminary review so that it focuses
thinking on some appropriate means of currently regulated and newly deemed only on administrative issues and
addressing the premarket authorization categories of products, we intend to allowing submission deficiencies to be
requirements for newly deemed ENDS identify topics for which rulemaking or communicated to the applicant more
products. If FDA determines that more product specific guidance is quickly; (3) providing information on
additional guidance is necessary to help appropriate. FDA’s Web site about the three
manufacturers prepare marketing Moreover, along with finalizing this pathways available to market products
applications, FDA will issue additional rule, FDA is setting forth an initial 2- (including SE) and developing public
guidance and publish a notice of year compliance period for the Webinars to explain the Agency’s
availability in the Federal Register. submission of a PMTA for newly processes; and (4) publishing guidance
Further, if at the time of the deemed, new tobacco products, documents. FDA intends to act as
conclusion of the continued compliance followed by a continued compliance expeditiously as possible with respect to
period, the applicant has provided the period of up to 12 months for FDA to all new applications, ensuring that
needed information and review of a review the application. FDA believes statutory standards are met.
pending marketing application has that this will give sufficient time for (Comment 62) One comment
made substantial progress toward manufacturers of such products to suggested FDA allow for submission of
completion, FDA may consider, on a prepare high quality applications, and a confidential e-cigarette product report
case-by-case basis, whether to defer for FDA to review new applications as in order to satisfy premarket review
enforcement of the premarket expeditiously as possible, while requirements. Similarly, another
authorization requirements for a ensuring that the statutory standards are comment encouraged FDA to establish a
reasonable time period. met. FDA’s compliance policy is further ‘‘Tobacco Product Master File’’ (TPMF)
described in section V.A of. system similar to the Agency’s Drug
B. Responses to Comments Regarding (Comment 61) Comments were split Master File (DMF) and Food Additive
Compliance Periods for Premarket as to whether the NPRM’s contemplated Master File (FAMF) systems to allow for
Review Requirements premarket review compliance e-cigarette/personal vaporizer and
(Comment 60) FDA received many timeframes (i.e., 24 months for e-liquid suppliers to submit confidential
comments suggesting that we change the manufacturers to submit and for FDA to product information (including
proposed compliance period for receive a marketing application) should information on formulations, facilities,
submitting marketing applications. apply to manufacturers of newly processes, and articles used in the
Some comments suggested that the deemed products. While many industry manufacturing, processing, packaging,
compliance period should be 24 months comments sought additional time to and storing of ingredients used).
from the date FDA either announces its comply with these requirements, many (Response) FDA does allow for the
intent to no longer exercise enforcement other comments suggested that the submission and use of information to be
discretion regarding premarket reason Congress delayed application of incorporated by reference similar to
requirements or issues product-specific certain requirements to the currently master file programs for other FDA-
guidance on the preparation of PMTAs regulated products (e.g., cigarettes and regulated products. In addition,
and the submission of HPHC testing smokeless tobacco) was to account for elsewhere in this issue of the Federal
results. They suggested that the issuance the creation, staffing, and training for a Register, FDA has made available a final
of the guidance documents be based new FDA center. In addition, they stated guidance to provide information on how
to establish and reference a TPMF. compliance period. They noted that process and will continue to hold public
TPMFs are expected to help applicants FDA currently employs a ‘‘refuse-to- Webinars and meetings with industry.
of newly deemed products prepare accept’’ policy for SE applications that In the category of cigars, and for
premarket and other regulatory allows FDA to make a threshold premium cigars in particular, we expect
submissions because they can reference determination as to whether an SE that some products will remain on the
information in TPMFs rather than application is sufficiently complete for market due to their status as
develop the information on their own. the Agency to review. They stated that grandfathered products, and that others
Such a system would be especially this policy will help to ensure that will be able to make use of the SE
helpful in the area of newly deemed manufacturers of the newly deemed pathway.
tobacco products. Because of the nature products do not try to unduly extend (Comment 66) While many comments
of upstream supply of many the time that products are marketed stated that they needed additional time
components for ENDS products, without FDA review of their to comply with premarketing
especially e-liquids, FDA anticipates applications. requirements, many other comments
that commercial incentives will be (Response) FDA agrees. FDA plans to stated that the contemplated 2-year
sufficient to drive manufacturer reliance take all reasonable measures to ensure compliance period was too long. For
on the system of master files. We note that applications are reviewed in a example, comments jointly submitted
that, at present, FDA understands that, timely manner. FDA intends to continue by 24 health and medical organizations
based on publically available employing its ‘‘refuse-to-accept’’ policy stating that the contemplated 24-month
information, the number of entities for SE Reports and other marketing compliance period included in the
engaged in upstream production of applications (including SE Exemption NPRM would prolong the public’s
liquid nicotine and flavors specifically Requests and PMTAs). exposure to products that contain
developed for use with e-liquids is (Comment 65) Many comments nicotine, a highly addictive substance,
small, in the range of seven to thirteen suggested that FDA should develop a and that, in their view, do not meet the
entities (see earlier discussion in product category specific framework for statutory standard for the grant of a
response to comment 34). Given the submission of PMTAs in light of the marketing order (Comment No. FDA–
nature of the marketplace, FDA expects large number of products for which 2014–N–0189–79772.). They stated that
that the master file system will be PMTAs will be required, the size and it would allow manufacturers to
widely appealing and widely utilized by cost of PMTAs, and FDA’s available continue to market the newly deemed
the ENDS industry. resources. The comments suggested that products in ways that appeal to youth
(Comment 63) At least one comment the compliance period should be based and to manipulate the content of these
stated that FDA should prioritize review on the date FDA issues a category products in uncontrolled ways for an
of applications for products currently on specific guidance document. The indefinite period (id.). These comments
the market over those seeking to enter comments stated that, without category also argued that a 2-year compliance
the market and that FDA should specific guidance, the PMTA process period will result in large numbers of
establish clear review deadlines. will effectively eliminate certain adolescents experimenting with newly
Another comment suggested that tobacco product categories, including deemed products and becoming
priority should be given to those the premium cigar industry. These established e-cigarette users or users of
products whose marketing is unlikely to comments asserted that it was Congress’ other tobacco products. Some suggested
be seen by youth or is limited to existing intent to treat categories of tobacco that FDA reduce the compliance period
adult users of the product. products differently, as shown by the to 6 months or 12 months and others
(Response) During the initial provisions banning flavored cigarettes, suggested different compliance periods
implementation of the Tobacco Control providing special considerations for SE reports, SE exemption requests,
Act, FDA received a large number of regarding menthol, establishing MRTP and PMTAs. One comment stated that
applications for currently marketed provisions, and creating baseline FDA’s burden estimates show that the
tobacco products. For these provisional standards under sections 910 and 907. PMTA process should take 18 months,
products being reviewed through the SE (Response) As stated previously, the so the compliance period should not
pathway, in order to appropriately statute specifies the premarket pathways extend beyond 18 months.
prioritize review, FDA performed a for tobacco products. Congress subjected Alternatively, other comments stated
public health impact evaluation of the all new tobacco products to the same that there should not be any compliance
product’s potential to raise different premarket review requirements in period for products because the PMTA
questions of public health. Currently sections 905 and 910. FDA has taken process was created to provide a higher
marketed products with the highest many steps to reduce and prevent scrutiny of review for new products
potential to raise different questions of backlogs of marketing applications with unknown health risks and a
public health were placed in the tier to pending FDA review and intends to act compliance period is contrary to this
be reviewed first. If appropriate, FDA as expeditiously as possible with purpose. They also stated that a
may consider using a prioritization respect to all new applications, while compliance period would allow the
method for newly deemed products. ensuring that statutory standards are industry to flood the market place with
FDA understands the value of met. Elsewhere in this issue of the products and manufacturers would not
establishing timelines for review of Federal Register, FDA has made have an incentive to quickly develop
applications. For products not on the available draft guidance, which when high-quality applications. In addition,
market on the effective date, FDA final will describe FDA’s current some comments suggested that FDA
intends to establish review performance thinking regarding some appropriate should not provide a compliance period
goals in the future as it did with means of addressing the premarket for combusted products, such as pipe
currently regulated products. authorization requirements for newly tobacco or cigars, because there is no
(Comment 64) Some comments deemed ENDS products. FDA may issue parallel provision in the current statute
suggested that FDA continue to employ additional category specific guidance as for such products.
measures to ensure that completed SE appropriate. FDA is committed to Some comments also suggested that
reports and PMTAs are submitted as helping industry better understand the manufacturers that sell flavored tobacco
expeditiously as possible during the tobacco product premarket review products or that market tobacco
products to children should not be and studies provided data and proposed compliance period would
afforded any compliance period to information regarding youth and young benefit larger companies with more
satisfy the premarket review adult use of flavored tobacco products resources to complete product
requirements of the FD&C Act (79 FR at in recent years. (E.g., Refs. 49, 50, 51, applications at the expense of small and
23176). For example, two large 52, 53, 54, 55, 56). And flavors appear mid-size companies (e.g., Comment No.
organizations dedicated to the health of to encourage greater use. (E.g., Ref. 57; FDA–2014–N–0189–76162). FDA notes
youth and young adults urged FDA not Refs. 58, 59). The availability of that a shorter period would have an
to grant a compliance period of any appealing flavors is a commonly cited even greater impact on these businesses.
length for products sold in reason for use of non-combusted In light of these considerations, FDA
characterizing flavors other than tobacco products among young tobacco users. believes that a two-year compliance
or any covered tobacco products that (E.g., Refs. 60, 61) period for flavored products, as with
use marketing practices known to However, several considerations other tobacco products, represents the
appeal to children and youth (Comment weigh against a shorter compliance exercise of its enforcement discretion in
No. FDA–2014–N–0189–67268; period for flavored products. There are a way that strikes an appropriate
Comment No. FDA–2014–N–0189– potential countervailing health balance between providing industry
79413.). concerns. At least some flavored time to transition and protecting the
Many comments also stated that combusted products (which are of public health. Over time, FDA expects
manufacturers should not be able to particular concern because they are to see additional data on the role of
avail themselves of the compliance known to present similar risks to certain flavored products in supporting
period unless they agree to restrict their cigarettes and are youth appealing) are reduction in or abstinence from the use
marketing to adults. However, some likely to be ‘‘grandfathered’’ and, of combusted products, as well as
comments expressed concern as to how therefore, would remain on the market further data on the role of flavored
such a restriction could be administered regardless of the compliance period or products in youth initiation, use, and
in accordance with the First enforcement policy for newly deemed, dual use. Such data will help inform
Amendment. In addition, Ranking noncombusted flavored products. And, FDA’s regulation of, and product
minority members of the Energy and in any event, comments suggested that standards for, these and other tobacco
Commerce Committee, Health the availability of flavors in non- products.
Subcommittee, and Oversight and combusted tobacco products, such as In developing this compliance period,
Investigations Subcommittee, U.S. ENDS, are appealing to current smokers FDA balanced three important public
House of Representatives called for a of combusted products and may entice health considerations: Concern about
more protective compliance period than smokers to consider switching to e- the extended availability of newly
the one contemplated in the NPRM, cigarettes. (e.g., Comment No. FDA– deemed, new tobacco products without
arguing that a 24-month compliance 2014–N–0189–75088; Comment No. scientific review; concern about
period ‘‘puts the nation’s youth at risk’’ FDA–2014–N–0189–79096). And FDA is flavored products’ youth appeal; and
(Comment No. FDA–2014–N–0189– aware of emerging self-reports from preliminary data that some individuals
80119). current and former cigarette smokers may potentially use such products to
(Response) Once this rule takes effect, supporting this claim. (See Refs. 62, 63.) transition away from combusted tobacco
it will be illegal to sell these tobacco Section VIII.F below discusses the use. Taking these factors into account,
products to anyone under the age of 18. preliminary evidence available to date and based on currently available
This final deeming rule is foundational, regarding effectiveness of ENDS to help scientific evidence, FDA determined
affording FDA with the authority to smokers transition from, or reduce their that the compliance periods described
issue other regulations restricting sales consumption of, combusted tobacco in Section V.A. strikes an appropriate
and distribution, including advertising products. But at least some think that balance to protect public health. FDA is
and promotion, under section 906(d). flavor variety is very important. (See, establishing staggered compliance
FDA struck a balance by revising the e.g., Ref. 63). More research, especially periods based on the expected
initial compliance period for SE longitudinal research, is needed to complexity of the applications and
exemption requests and SE reports to 12 understand how flavoring impacts continued compliance periods for FDA
and 18 months, respectively, and is tobacco use over time (Ref. 64). review such that our exercise of
setting forth a 2-year compliance period Finally, as with other tobacco enforcement discretion will end twelve
for manufacturers of newly deemed, products that will be regulated under months after each initial compliance
new tobacco products to submit (and this rule, FDA is cognizant of the period. In addition, FDA is announcing
FDA to receive) a PMTA. FDA believes transition that will be required for that it intends in the future to issue a
that these time periods are sufficient for regulated entities. Several comments proposed product standard that would,
manufacturers to prepare high quality expressed concern that even the if finalized, eliminate characterizing
applications addressing the proposed 24-month compliance period flavors in all cigars including cigarillos
requirements in the statute. was not sufficient to submit complete and little cigars.
FDA has given extensive applications for all of their products. Elsewhere in this issue of the Federal
consideration to having different For example, one comment noted that Register, FDA has made available draft
compliance periods for flavored and most of the e-cigarette market ‘‘are small guidance, which when final will
non-flavored products. There is some and medium-sized businesses owned describe FDA’s current thinking
evidence suggesting that flavored and operated by individuals and regarding some appropriate means of
products pose a greater public-health families [and] most, if not all of these addressing the premarket authorization
risk than non-flavored products. FDA smaller enterprises lack the resources to requirements for newly deemed ENDS
understands that the appeal of flavors tackle such a high administrative products. FDA recognizes that flavored
and use of flavored tobacco products burden’’ associated with submitting e-liquids are especially attractive to
have an important role in the initiation multiple PMTAs within the time period youth and young adults. Attractiveness
and continued use of tobacco products, (Comment No. FDA–2014–N–0189– to youth and young adults is an
and in the health risks associated with 80496). Several comments also important factor in evaluating whether
use of these products. Many comments expressed concern that the 24-month the marketing of a product is
appropriate for the protection of the do not contain tobacco and are not • water filtration base additives
public health. Manufacturers should derived from tobacco and do not affect (including those which are flavored)
provide information on possible or alter the performance, composition, used with waterpipe tobacco; and
toxicity, addictiveness, and appeal of constituents, or characteristics of a • pouches or flavorings used with any
flavored tobacco products with their tobacco product. Accessory examples of the newly deemed products (whether
premarket review applications. also include humidors that solely or not the pouch or flavoring contains
control the moisture and/or temperature nicotine or tobacco).
VI. Components, Parts, and Accessories
of a stored product and a burner that Some examples of materials intended
In the preamble to the NPRM, we solely provides an external heat source or reasonably expected to alter or affect
asked for comments, including to initiate but not maintain combustion the tobacco product’s performance,
supporting facts, research, and other of a tobacco product. As stated in the composition, constituents, or
evidence, regarding FDA’s proposal to NPRM, accessories of newly deemed characteristics are:
include components and parts of the products are not deemed with this final • The cellophane wrapping or plastic
newly deemed products (but not rule. tube for a single cigar;
accessories) under the scope of this rule. In addition, FDA is defining • a plastic bag or tin holding loose
We also asked for comments as to ‘‘component or part’’ to mean any pipe tobacco; and
whether FDA should define components software or assembly of materials • a glass or plastic vial container of e-
and parts of tobacco products and how intended or reasonably expected: (1) To liquid.
those items might be distinguished from alter or affect the tobacco product’s Although these examples are materials
accessories (79 FR 23142 at 23152 and performance, composition, constituents,
that are generally intended to prevent
23153). After reviewing the comments, or characteristics; or (2) to be used with
unintended changes to the
FDA is finalizing this rule to include or for the human consumption of a
characteristics of the tobacco product,
components and parts of the newly tobacco product. The definition
they are also intended or reasonably
deemed products (but excluding excludes anything that is an accessory
expected to alter or affect the
accessories of such products) within the of a tobacco product.
We note that the term ‘‘material’’ performance, composition, constituents,
scope of this rule. FDA is also
means an assembly of ingredients, or characteristics of a tobacco product.
explaining its current compliance policy
including additives. Materials are For example, these materials often leach
with respect to components and parts
assembled to form components and ingredients into the consumed product.
and certain requirements that will
parts. For example, material could be As some comments noted, with ENDS,
become effective with this deeming rule.
considered the glue or paper pulp for a there is the potential for substances to
A. Definitions cigarette where the paper pulp includes leach from the containing vial into the
In response to comments, FDA is multiple ingredients (e.g., multiple e-liquid and these leachates may be
including definitions of ‘‘accessory’’ and types of tobacco, water, and flavors) inhaled when the e-liquids are used as
‘‘component or part’’ in parts 1100, assembled into the paper (or pulp intended, posing additional health risks
1140, and 1143. As stated in this final depending on the water content). A for consumers. They often can also
rule, an ‘‘accessory’’ means any product material could be considered the plastic impact the moisture level or shelf life of
that is intended or reasonably expected in the mouthpiece of an ENDS a tobacco product (e.g., whether a cigar
to be used with or for the human containing multiple ingredients and is in a hard pack or soft pack, and
consumption of a tobacco product; does additives assembled together to create a whether pipe tobacco is in a plastic or
not contain tobacco and is not made or product. metal container). The moisture level of
derived from tobacco; and meets either In determining whether software or an a tobacco product, and changes to that
of the following: assembly of materials might be moisture level, can, for example,
(1) Is not intended or reasonably ‘‘intended or reasonably expected’’ to significantly impact consumers’
expected to affect or alter the alter or affect the tobacco product’s exposure to nicotine and other
performance, composition, constituents, performance, composition, constituents, constituents. In some cases, menthol or
or characteristics of a tobacco product, or characteristics or to be used with or other ingredients may have been
or for the human consumption of a tobacco applied to these materials in order to
(2) Is intended or reasonably expected product (and, therefore, whether it is a have them become incorporated into the
to affect or maintain the performance, component or part), FDA is not bound consumed product.
composition, constituents, or by the manufacturer or distributor’s FDA recognizes that in some
characteristics of a tobacco product but subjective claims of intent. Rather, FDA circumstances some assemblies of
(i) solely controls moisture and/or can consider the totality of the materials can operate as both an aspect
temperature of a stored product; or (ii) circumstances, including direct and of the package and a component or part
solely provides an external heat source circumstantial objective evidence, of the tobacco product. In such
to initiate but not maintain combustion which encompasses a variety of factors situations, the Agency is only
of a tobacco product. such as circumstances surrounding the examining a distinct subset of packaging
FDA has structured paragraph (2)(ii) distribution of the product or the materials that function as a component
to ensure that coils and charcoal are not context in which it is sold (see, e.g., 21 or part of a tobacco product by having
encompassed by the definition of CFR 201.128 (drugs), 21 CFR 801.4 the potential to alter or affect the
‘‘accessory.’’ (devices); see also U.S. v. Travia, 180 tobacco product’s performance,
‘‘Composition,’’ as used in this F.Supp.2d 115, 119 (D.D.C. 2001)) and composition, constituents, or
definition, means the manner in which sales data. characteristics. Packaging materials that
the materials, including, for example, Some examples of materials intended do not alter or affect, and are not
ingredients, additives, and biological or reasonably expected to be used with reasonably expected to alter or affect,
organisms, are arranged and integrated. or for the human consumption of a the tobacco product’s performance,
Examples of accessories are ashtrays, tobacco product are: composition, constituents, or
spittoons, hookah tongs, cigar clips and • Atomizers and cartomizers used characteristics are not components or
stands, and pipe pouches, because they with ENDS; parts of a tobacco product. For example,
a glass vial containing an e-liquid is a regulations, while also taking into Act states that chapter IX of the FD&C
component or part of the tobacco account retailers who are making a good Act applies to all cigarettes, cigarette
product, whereas a hard plastic blister faith effort to comply with the law. tobacco, roll-your-own tobacco, and
pack in which the glass vial of e-liquid Many comments provided suggested smokeless tobacco and to any other
is distributed and sold to consumers is definitions for ‘‘component or part’’ and tobacco products that the Secretary of
not. ‘‘accessory.’’ Other comments stated Health and Human Services by
FDA intends to seek additional public that FDA should not define these regulation deems to be subject to
comment and issue a rule or guidance categories of products, because it is too chapter IX. Section 201(rr) of the FD&C
to provide further clarification on difficult to properly define such large Act defines ‘‘tobacco product,’’ in
assemblies of materials that are a categories of products and any relevant part, as any product made or
‘‘component or part’’ of a tobacco definitions quickly would become derived from tobacco that is intended
product because they are intended or outdated. for human consumption, including any
reasonably expected to alter or affect the (Response) FDA agrees that component, part, or accessory of a
tobacco product’s performance, definitions of component or part and tobacco product (except for raw
composition, constituents, or accessory would be appropriate and has materials other than tobacco used in
characteristics or are intended or included definitions consistent with manufacturing a component, part, or
reasonably expected to be used with or factors noted in the proposal and accessory of a tobacco product).
for the human consumption of a tobacco consideration of comments. Although Therefore, the statute gives FDA
product. we indicated in the NPRM that authority to deem additional tobacco
Many comments specifically asked for accessories are not expected to be used products, including all components,
clarification and examples of which with or for consumption of a tobacco parts, and accessories, except for raw
objects used with waterpipe tobacco product, we also indicated our materials (other than tobacco) that go
would be considered components, parts, expectation that accessories will have into manufacturing of components,
and accessories. The following is a little impact on the public health. While parts, or accessories of a tobacco
nonexhaustive list of examples of the definition of accessory is different product. Examples of such raw
components and parts used with than the description in the NPRM, based materials would be unprocessed acacia
waterpipe tobacco: Flavor enhancers; on consideration of the comments, it gum (taken from a tree and not
hose cooling attachments; water captures our original intent and the processed) and minted titanium dioxide
filtration base additives (including those classes of products that the Agency (used for whitening cigarette and
which are flavored); flavored hookah views as accessories. The definitions of tipping paper). In this rule, FDA is not
charcoals; and bowls, valves, hoses, and component, part, and accessory, which deeming accessories to be subject to
heads. The following is a nonexhaustive are discussed at the beginning of this chapter IX and, although it is deeming
list of objects used with waterpipe section VI.A of the document, are all components and parts to be subject
tobacco that would likely be considered included in §§ 1100.3, 1140.3, and to chapter IX, it is not applying the
accessories: Hookah glow balls, foil 1143.1. additional restrictions (i.e., minimum
pokers, shisha oyster forks, tongs, and (Comment 68) Several comments age and identification, vending, and
bags. expressed concern about FDA’s health warnings provisions) to
Many comments also sought statement in the NPRM that the Agency components and parts that are not made
clarification and examples as to which may consider rule revisions if FDA later or derived from tobacco. Nevertheless, if
objects used with e-cigarettes would be decides to extend its regulatory FDA were to consider extending its
considered components, parts, and authority to components and parts of authority to accessories or to apply
accessories. The following is a newly deemed tobacco products that do additional restrictions to components or
nonexhaustive list of examples of not contain tobacco or nicotine. They parts, FDA would do so through the
components and parts of ENDS stated that the Tobacco Control Act does rulemaking process.
(including e-cigarettes): Atomizers, not permit FDA to regulate such objects (Comment 69) A few comments
flavors used or intended to be used with if they do not employ tobacco as a raw expressed concern that the rule would
ENDS (with or without nicotine), e- material. create incentives for manufacturers to
liquid solvents, tanks and tank systems, (Response) FDA disagrees. To clarify, separate nicotine-containing
batteries (with or without variable FDA is finalizing its proposal to deem components from nonnicotine-
voltage), coils, cartomizers, digital all tobacco products, including all containing components to evade
display/lights to adjust settings, components and parts, but excluding regulatory requirements. They stated
clearomisers, and programmable accessories of newly deemed tobacco that the rule would allow minors to
software. The following is a products, to be subject to chapter IX of purchase nicotine delivery systems, as
nonexhaustive list of examples of the FD&C Act. However, the additional long as they do not contain e-liquids,
objects used with e-cigarettes or other restrictions (i.e., minimum age and and obtain the e-liquids from other
ENDS that would likely be considered identification, vending, and health sources (e.g., friends, parents, online).
accessories: Screwdrivers and lanyards. warnings provisions) only apply to (Response) FDA understands these
A summary of comments regarding ‘‘covered tobacco products.’’ The health concerns. However, this deeming rule
these issues, and FDA’s responses, is warning provisions apply to ‘‘covered covers tobacco product components and
included as follows. tobacco products,’’ cigarette tobacco, parts intended or reasonably expected to
(Comment 67) Many comments urged and roll-your-own tobacco. The term be used with or for the human
FDA to define components, parts, and ‘‘covered tobacco products’’ includes all consumption of a tobacco product. In
accessories (particularly for e-cigarettes) newly deemed tobacco products except addition, as stated in § 1140.16, retailers
to standardize enforcement nationally, those components and parts that are not of newly deemed tobacco products may
prevent confusion in the marketplace made or derived from tobacco. not sell covered tobacco products
(including among retailers), close any FDA also disagrees that the FD&C Act (through any medium, including the
potential loopholes to circumvent does not authorize FDA to regulate Internet) to individuals under 18 years
compliance, increase transparency, and products that do not employ tobacco as of age. FDA will continue to actively
ensure inspectors are enforcing a raw material. Section 901 of the FD&C enforce the minimum age restriction for
mail order and Internet sales, which draft guidance, which when final will warning is overused, there is the danger
will help to reduce youth access to the represent some appropriate means of that it will grow stale.
nicotine and tobacco containing addressing the premarket authorization (Comment 72) One comment
components, without which they cannot requirements for newly deemed ENDS disagreed with what it characterized as
use the other components of ENDS. products and will include FDA’s current FDA’s assertions that tobacco product
(Comment 70) Some comments stated thinking regarding compliance with accessories do not pose a public health
that the objects used in or with an e- existing voluntary standards for ENDS risk or environmental risk and stated
cigarette (including batteries, wire, batteries. that such objects are harmful to humans
screws, silica) should be beyond the In addition, nicotine-containing and the food chain.
scope of FDA’s authority, because they cartridges that include varying degrees (Response) FDA wishes to clarify
do not become part of the tobacco of nicotine are components or parts and language included in the NPRM
product until they are constructed by subject to FDA’s chapter IX authorities regarding accessories (79 FR 23142 at
the consumer. Others stated that FDA because they constitute an assembly of 23153). FDA did not propose, nor is it
should regulate these objects given materials intended or reasonably stating in this final rule, that tobacco
reports regarding the malfunctioning of expected to be used with or for the product accessories do not pose any
certain e-cigarette components (e.g., human consumption of a tobacco public health risk. Instead, we indicated
dangers of exploding batteries (Ref. 65)) product and do not constitute a tobacco that tobacco product accessories as
and the fact that the e-liquid cannot be product accessory. Upon the effective defined in the rule likely have less
consumed without each component date of this final rule, FDA intends to (rather than ‘‘no’’) risk to the overall
working in conjunction to deliver regulate the entire line of cartridges public health, which we reiterate in this
nicotine to the consumer. These (including cartridges that include final rule. FDA is regulating
comments asked FDA to clarify whether varying degrees of nicotine or those that components and parts (and not
the Agency will regulate only the do not contain nicotine, if they meet the accessories) of the newly deemed
nicotine-containing cartridges in a line definition of component or part). products, so the Agency can better focus
of products that includes varying (Comment 71) Several comments its resources on those objects with a
degrees of nicotine including cartridges urged FDA to include all e-liquids in the greater likely impact on public health.
advertised as nicotine free if they are minimum age and identification Similarly, FDA did not state that this
intended to be used with or for the requirements and vending machine rule would not impact the environment.
human consumption of a tobacco restrictions in the revised part 1140, Rather, the environmental analysis
product. including e-liquids that do not contain included in the NPRM stated that the
(Response) This final deeming rule nicotine, because they are easily impacts of this rule will not have a
deems all tobacco products as they are accessible to minors online and can be significant impact on the human
defined in section 201(rr) of the FD&C mixed with nicotine. In addition, they environment according to the standard
Act, except accessories of newly suggested that FDA require the imposed by the National Environmental
deemed products, but including proposed addiction warning on all Policy Act, as stated in the proposed
components and parts as defined in this components or parts sold in conjunction environmental assessment (EA). The
rule. The wires, screws, and silica meet with e-liquid. final EA and Finding of No Significant
the definition of component or part, as (Response) FDA disagrees. Under this Impact (FONSI) are included in the
they are an assembly of materials deeming rule, e-cigarettes that contain docket.
intended or reasonably expected to be nicotine cannot be sold to youth under (Comment 73) The comments
used with or for the human the age of 18. In addition, an e-liquid suggested several different regulatory
consumption of a tobacco product and with nicotine is a covered tobacco approaches for components, parts, and
are not accessories of a tobacco product. product and, therefore, will be required accessories. First, several comments
FDA also remains concerned about to have a health warning under part stated that FDA should weigh the
reports of exploding batteries. Batteries 1143. As previously discussed, an e- relative risks of these products and
that are co-packaged with other liquid without nicotine is a component impose the least burdensome
components or parts of an ENDS (e.g., (and subject to FDA’s tobacco control requirements necessary to effectively
cartridges and tanks) or otherwise authorities), if it is intended or manage or mitigate those risks. They
intended or reasonably expected to be reasonably expected to be used with or suggested that FDA treat these products
used with or for the consumption of for the human consumption of a tobacco the way the Agency does with its review
ENDS are components or parts and product (e.g., with liquid nicotine) and of marketing applications. For example,
subject to FDA’s tobacco product does not constitute a tobacco product they noted that FDA’s draft and final
authorities. However, as noted accessory, but an e-liquid that does not guidance documents on PMTAs and SE
elsewhere in this document, for ENDS contain nicotine or tobacco is not reports explain that FDA does not
hardware or delivery system required to carry a warning, nor is it intend to enforce the requirements of
components or parts, such as batteries, subject to the minimum age and either section 910 or 905(j) of the FD&C
FDA expects that it may be difficult for identification requirements and vending Act for components of regulated tobacco
manufacturers to obtain premarket machine restrictions under parts 1140 products that are sold or distributed
authorization for such products, given and 1143 because it is not a covered solely for further manufacturing into
the great extent of possible variations in tobacco product as defined by this rule. finished tobacco products because the
combinations of hardware components, Because components without nicotine Agency anticipates ‘‘receiving relevant
if all considered and sold separately. or tobacco are intended to be used with information regarding such new tobacco
Thus, with respect to such apparatus, a covered tobacco product, which products in the PMTA submission for
FDA expects that manufacturers will be contains nicotine or tobacco, FDA the finished regulated tobacco
most successful where authorization is believes that it is appropriate to require products’’ (citing draft guidance,
sought for entire delivery systems, only the covered tobacco product to be ‘‘Applications for Premarket Review of
rather than individual components. subject to the minimum age and New Tobacco Products’’). Second, some
Elsewhere in this issue of the Federal vending machine provisions and to comments believed that manufacturers
Register, FDA also has made available carry the warning. Moreover, if a of e-cigarette components and parts
should be required to submit marketing accessories and, therefore, not subject to that such objects are not standardized
applications given the aerosols and FDA’s chapter IX authorities. For and that their quality, composition, and
‘‘vapors’’ that consumers generate when example, batteries used in advanced safety are not regulated and, therefore,
using certain components or parts. personal vaporizers can be found in they should be subject to FDA’s chapter
Third, some comments stated that laptop battery packs or cordless drill IX authorities.
instead of requiring manufacturers of packs. These comments also stated that (Response) FDA does not believe it is
components and parts to comply with items such as lighters and batteries may necessary for tanks and cartridges that
the automatic requirements for the (or may not) be used in consumption of do not contain nicotine or tobacco to be
newly deemed products, FDA should a tobacco product or are regulated by subject to the vending machine
require them to ensure that all of their the Consumer Product Safety Act (as are restrictions because they can only be
components and parts that contain child-resistant lighters) and, therefore, used to consume tobacco or nicotine
tobacco or tobacco derivatives are should not be subject to FDA’s tobacco derived from tobacco with other
shipped and packaged with labeling that product authorities. products that are subject to the
indicates that they are intended for (Response) FDA agrees that it is not additional restrictions. However, FDA is
further manufacture. necessary to regulate batteries that are aware of the current lack of regulation
(Response) At this time, FDA intends not intended or reasonably expected to or standardization of tanks and
to limit enforcement of the premarket be used with a tobacco product under cartridges, which are components and
review requirements to finished tobacco its tobacco product authorities. parts that FDA is deeming to be subject
products. For purposes of this However, it is important that batteries to FDA’s chapter IX authorities with this
compliance policy applicable to newly that are co-packaged with other parts of rule. After the effective date of this final
deemed products, a finished tobacco an ENDS (e.g., cartridges and tanks) or rule, FDA will have authority to issue
product refers to a tobacco product, otherwise intended or reasonably tobacco product manufacturing practice
including all components and parts, expected to be used with ENDS are regulations under section 906(e) of the
sealed in final packaging intended for components subject to FDA’s tobacco FD&C Act and product standards under
consumer use (e.g., filters or filter tubes product authorities. FDA remains section 907 of the FD&C Act to address
sold separately to consumers or as part concerned about reports of exploding e- the quality, composition, and safety of
of kits). FDA does not at this time cigarette batteries and finds that these components and parts. FDA also
intend to enforce these requirements for regulating them can help address these notes that these components and parts
components and parts of newly deemed problems. Toward that end, elsewhere will usually be subject to premarket
products that are sold or distributed in this issue of the Federal Register, review, either by themselves, as
solely for further manufacturing into FDA has made available draft guidance, components and parts intended for
finished tobacco products. In addition, which when final will describe FDA’s consumer use, or as components and
FDA does not believe that it is current thinking regarding some parts of products that undergo further
warranted at this time to require appropriate means of addressing the manufacturing for which the end
components and parts that contain premarket authorization requirements product will be subject to premarket
tobacco or tobacco derivatives to for newly deemed ENDS products, review.
include labeling that indicates they are including compliance with existing (Comment 78) A few comments
intended for further manufacture. voluntary standards for ENDS batteries. expressed concern with FDA’s
(Comment 74) Some comments stated (Comment 76) Some comments stated characterization of objects used during a
that FDA should regulate all that walk-in humidors for cigars should waterpipe tobacco session (i.e., the
components, parts, and accessories, as not be subject to FDA regulation burners, holders, screens, and other
long as they have a foreseeable impact because they are important to retailers objects used with waterpipe tobacco).
on the public health. They believed that and allow consumers to browse a They stated that all waterpipe burners
omitting accessories from the scope of retailer’s stock and make a selection. and holders can affect waterpipe
the deeming rule ignores the clear (Response) As discussed previously, tobacco emissions, and noted that foil is
statutory language that explicitly any item that is intended or reasonably heated to the same extent as charcoal
defines ‘‘tobacco product’’ to include expected to be used with or for the during waterpipe use and, therefore, can
accessories. human consumption of a newly deemed present a burning danger (Ref. 66). In
(Response) FDA disagrees. Although tobacco product; does not contain addition, the heating source, screen (or
Congress included ‘‘accessories’’ within tobacco or a tobacco derivative; and is aluminum foil), and hose can have a
the definition of ‘‘tobacco product’’ in intended or reasonably expected to significant impact on passive and active
section 201(rr) of the FD&C Act, it did affect or maintain the characteristics of exposure and smoking/puffing
not explicitly require that FDA include the newly deemed tobacco product but behaviors and, therefore, should be
all components, parts, and accessories solely controls moisture and/or components or parts subject to chapter
within the scope of its rule to deem temperature of a stored newly deemed IX of the FD&C Act.
additional tobacco products under tobacco product, is an accessory and (Response) FDA has included
section 901. Accessories, as defined in excluded from this deeming rule. definitions of ‘‘component,’’ ‘‘part,’’ and
this rule, likely have less risk to the Therefore, unless the humidor is ‘‘accessory’’ with this final rule to
overall public health, and the benefits to designed to affect the tobacco product in provide additional clarity regarding the
overall public health for deeming a manner other than controlling characterization of products used during
accessories subject to FDA’s tobacco moisture or temperature, such walk-in a waterpipe session. According to these
product authorities are also likely less. cigar humidors are not subject to this definitions, the screen (or aluminum
Therefore, FDA is excluding them from rule. foil) and hoses that are co-packaged
the scope of this deeming rule. (Comment 77) A few comments with other parts of a hookah or
(Comment 75) Some comments stated expressed concern that e-cigarette tanks marketed, advertised, or otherwise
that items also used for purposes other and cartridges would not be included intended for use with a hookah are parts
than for tobacco use (i.e., a lighter or within the proposed vending machine or components and subject to FDA’s
matches that can be used to light restrictions because they do not contain tobacco product authorities. However,
candles) should be classified as nicotine at the time of sale. They said for example, an external burner or
heating source that is not incorporated filters, holders, lighters, ashtrays, and (Comment 82) One comment
into the hookah would be an accessory, cases. requested that flavored rolling papers be
provided that it does not contain (Response) FDA generally expects included as a newly deemed tobacco
tobacco or a tobacco derivative and cigar tip cutters, permeable humidor product. Another comment claimed that
solely provides an external heat source buttons, holders, ashtrays, and cases flavored papers should not be subject to
to initiate but not maintain combustion would be accessories that are not subject FDA’s tobacco control authorities,
of a tobacco product. The holder also is to FDA regulation. In addition, as stated because they do not pose a danger to
an accessory and not subject to chapter in this section (discussing the public health.
IX of the FD&C Act. definitions of component or part and (Response) Rolling papers intended
(Comment 79) A few comments accessory), for the purposes of this for use with cigarette tobacco or roll-
suggested that charcoal or wood cinder regulation, any item that does not your-own tobacco are already subject to
used with waterpipe tobacco should be contain tobacco or a tobacco derivative FDA’s tobacco control authorities under
considered a tobacco product and and is not integrated in a tobacco section 901 of the FD&C Act because
deemed under this regulation. They product, but rather solely provides an they are components of cigarettes and
explained that combustion of these external heat source, to initiate but not cigarette tobacco. Upon the effective
products produces toxicants and may maintain combustion of a tobacco date of this final rule, rolling papers
emit carcinogens, carbon monoxide, product (such as a lighter) is not subject (including flavored papers) intended for
polycyclic aromatic hydrocarbons, and to this deeming rule. However, use with newly deemed tobacco
other cancer causing agents. removable tips, mouthpieces, and filters products would be tobacco product
(Response) FDA finds that such are all intended to be used by adult components or parts and subject to
products are components or parts; consumers in the human consumption FDA’s chapter IX authorities.
therefore, they are subject to FDA’s of a tobacco and do not meet the
definition of accessory, therefore, are B. Discussion of Requirements
chapter IX authorities. They are an Associated With Components and Parts
assembly of materials intended or included within the scope of this final
rule. FDA received many inquiries about
reasonably expected to be used with or
(Comment 81) A few comments how the automatic provisions associated
for the human consumption of a tobacco
expressed concern that vaporizers sold with deeming tobacco products would
product and are not accessories. As we separately without nicotine can be
have noted throughout this document, apply to components and parts.
modified or ‘‘hacked,’’ which Components and parts of newly deemed
an accessory does not contain tobacco researchers found could increase toxins
and is not made or derived from tobacco products are subject to all of the
and other dangerous components, automatic provisions included in the
tobacco, and it meets one of the including formaldehyde (Ref. 67). They
following: (1) Is not intended or FD&C Act, as further discussed as
stated that online videos show how to follows.
reasonably expected to affect or alter the ‘‘hack’’ an e-cigarette, including how to
performance, composition, constituents, change the apparatus to increase the 1. Ingredient Listing (Sections 904(a)(1)
or characteristics of a tobacco product; temperature of the ‘‘vapor.’’ Because of and 904(c)); Health Document
or (2) is intended or reasonably these concerns, they argued that such Submission (Section 904(a)(4)); and
expected to affect or maintain the items should be considered components Registration and Product Listing
performance, composition, constituents, and parts and under FDA’s jurisdiction. (Section 905)
or characteristics of a tobacco product (Response) FDA agrees that vaporizers At this time, FDA intends to limit
but (i) solely controls moisture and/or are components or parts of a tobacco enforcement to finished tobacco
temperature of a stored product; or (ii) product. These objects are an assembly products. A finished tobacco product
solely provides an external heat source of materials intended or reasonably refers to a tobacco product, including all
to initiate but not maintain combustion expected to be used with or for the components and parts, sealed in final
of a tobacco product. Therefore, the consumption of a tobacco product and packaging intended for consumer use
charcoal or wood cinder intended or do not constitute tobacco product (e.g., filters, filter tubes, e-cigarettes, or
reasonably expected to be used with or accessories. Therefore, they are tobacco e-liquids sold separately to consumers
for the human consumption of product components or parts and or as part of kits). FDA does not at this
waterpipe tobacco are components or subject to FDA’s chapter IX authorities. time intend to enforce these
parts. Further, charcoal and wood FDA considers components or parts sold requirements for components and parts
cinders are not considered accessories directly to consumers to be finished of newly deemed products that are sold
given that they: (1) Do not contain tobacco products. A finished tobacco or distributed solely for further
tobacco and are not made or derived product refers to a tobacco product, manufacturing into finished tobacco
from tobacco; and (2) are intended or including all components and parts, products.
reasonably expected to alter the sealed in final packaging intended for
characteristics of a tobacco product but consumer use (e.g., filters or filter tubes 2. SE Reports and PMTAs (Section
do not solely control moisture and/or sold separately to consumers or as part 905(j) and 910)
temperature of a stored product and do of kits). FDA remains concerned about At this time, FDA intends to limit
not solely provide an external heat adverse events associated with ENDS enforcement to finished tobacco
source to initiate but not maintain use and finds that regulating them can products. FDA does not at this time
combustion. Instead, both charcoal and help address these problems. Toward intend to enforce these requirements for
wood cinder are used to maintain the that end, elsewhere in this issue of the components and parts of newly deemed
combustion of waterpipe tobacco. Federal Register, FDA has made products that are sold or distributed
(Comment 80) Many comments asked available draft guidance, which when solely for further manufacturing into
for clarification as to whether certain final will describe FDA’s current finished tobacco products.
items associated with cigar use should thinking regarding some appropriate
be termed ‘‘accessories,’’ including cigar means of addressing the premarket 3. Reporting of HPHCs (Section 915)
tip cutters, permeable humidor buttons, authorization requirements for newly At this time, FDA intends to limit
removable tips, mouthpieces, removable deemed ENDS products. enforcement to finished tobacco
products. See section IX for further that they do not inhale does not negate While exposure to higher levels of
discussion of ENDS retail the adverse health effects of tobacco cigar smoke for a longer period of time
establishments and the responsibilities smoke or demonstrate that cigars do not increases the adverse health risks due to
of upstream manufacturers for reporting cause secondhand smoke-related cigar smoking (just as it does for
of HPHCs. The Agency is working to disease in others. Therefore, we find cigarettes), the Surgeon General has
determine an appropriate compliance there is no appropriate public health stated that no amount of smoking is safe
policy to deal with HPHCs for newly justification to exclude premium cigars (Ref. 2). Further, there are no data
deemed products (including e-liquids) from the scope of the final deeming rule indicating that premium cigar users are
and is intending to issue guidance with and that it is appropriate to deem them. not susceptible to health risks, as
enough time for manufacturers to report discussed in section VII.C. FDA’s
A. Health Risks of Premium Cigars
given the 3-year compliance period. responses to comments on the health
Researchers estimate that regular cigar risks of premium cigars are included in
VII. Regulation of Cigars and Selection smoking was responsible for the following paragraphs.
of Option 1 approximately 9,000 premature deaths (Comment 84) Proponents of Option 1
As discussed in the preamble to the or almost 140,000 years of potential life stated there is no public health
NPRM (79 FR 23142 at 23150 through lost among adults 35 years or older in justification for exempting premium
23152), it has been suggested that 2010 (Ref. 68). Cigar smoke contains cigars and that deeming premium cigars
different kinds of cigars may have the many of the same harmful constituents will benefit the public health
potential for varying effects on public as cigarette smoke and may have higher immediately through the automatic and
health. Accordingly, FDA proposed two levels of several harmful compounds additional provisions and the
options for the categories of cigars to be (Ref. 68, citing Ref. 69 at 55–104). All imposition of future product standards.
subject to this deeming rule. Option 1 cigar smokers have an increased risk of They also stated that exempting
proposed to deem all products meeting oral, esophageal, laryngeal, and lung premium cigars would have a negative
the statutory definition of ‘‘tobacco cancer compared to non-tobacco users impact on the public health.
product,’’ except accessories of a (Refs. 35, 69). Among those who report (Response) FDA agrees. As stated in
proposed deemed tobacco product, to be inhaling cigar smoke, there are the NPRM, there will be many public
subject to FDA’s tobacco product significantly elevated levels of many health benefits associated with deeming
authorities under chapter IX of the types of cancer and other adverse health tobacco products (including products
FD&C Act. Option 2 proposed to deem effects, such as increased risk of heart referred to as premium cigars). For
all products meeting the statutory and pulmonary disease (Refs. 69, 70). example, the adulteration and
definition of ‘‘tobacco product,’’ except Cigar smokers also are at a marked misbranding provisions in sections 902
accessories of a proposed deemed increase in risk for chronic obstructive and 903 of the FD&C Act, as applied to
tobacco product and a subset of cigars pulmonary disease (COPD) and the newly deemed products, will protect
referred to as ‘‘premium cigars’’ to be experience higher mortality risk from consumers because FDA will be able to
subject to FDA’s tobacco product COPD than nonsmokers (Refs. 70, 71). In take enforcement action against any
authorities under chapter IX of the addition, cigar smokers have a higher non-compliant tobacco product, such as
FD&C Act. FDA notes that individual risk of fatal and nonfatal stroke than a product with false or misleading
hand rollers of cigars would be nonsmokers (Ref. 72). All cigars produce labeling or advertising. In addition,
considered manufacturers under chapter secondhand smoke, which causes ingredient listings and reports of HPHCs
IX of the FD&C Act, and subject to the negative health effects such as heart under sections 904 and 915 of the FD&C
same requirements as other tobacco disease and lung cancer in bystanders Act will assist FDA in better
product manufacturers. (Refs. 35, 69). understanding the contents of regulated
(Comment 83) Some comments that Nevertheless, we do note that the products. That information would assist
supported Option 1 stated that FDA 2014 Surgeon General’s Report states FDA in assessing potential health risks
should regulate premium cigars, in part, that when compared with persons who and determining if future regulations to
because they meet the statutory smoke cigarettes, those who use cigars address the health risks posed by
definition of ‘‘tobacco product.’’ exclusively have a lower risk for many particular products are warranted. With
(Response) FDA agrees. All cigars, smoking-related diseases (Ref. 9 at 428 application of the section 905
including those referred to as premium citing Ref. 69). Although smoke from registration and listing requirements,
cigars, meet the definition of a ‘‘tobacco cigars contains the same toxic FDA will be able to conduct biennial
product’’ under section 201(rr) of the substances as cigarette smoke, cigar inspections of tobacco product
FD&C Act. smokers generally smoke at a lower manufacturers. Further, implementation
After thorough review of the frequency and tend not to inhale the of the premarket review provisions of
comments and the scientific evidence, smoke, thus reducing (but not sections 905, 910, and 911 of the FD&C
FDA has concluded that deeming all eliminating) their exposure to its toxic Act will allow FDA to monitor product
cigars, rather than a subset, more substances (id.). Former cigarette development and changes and to
completely protects the public health smokers are more likely to inhale cigar prevent more harmful or addictive
and therefore has adopted Option 1 in smoke than are primary cigar smokers products from reaching the market.
the final rule. FDA has concluded that: who have never smoked cigarettes (id.). Moreover, there were no data provided
(1) All cigars pose serious negative While most studies cited in this to support the premise that there are
health risks, (2) the available evidence section do not explicitly pertain to different patterns of use of premium
does not provide a basis for FDA to premium cigars, the bulk of the cigars and that these patterns result in
conclude that the patterns of premium established data on the health effects of lower health risks.
cigar use sufficiently reduce the health cigar smoking is based on smokers of (Comment 85) Some comments
risks to warrant exclusion, and (3) traditional, large cigars and, therefore, is argued that exempting premium cigars
premium cigars are used by youth and applicable to the toxicity of premium from deeming would set a dangerous
young adults. The fact that some cigars given that they share the same precedent that it is appropriate for FDA
premium cigar smokers might smoke characteristics and are generally smoked not to regulate certain tobacco products
such products infrequently or report in similar ways. by virtue of their potential for varying
effects on public health. An exemption average plasma nicotine concentrations significant public health threat (Ref. 77)
could mislead consumers to believe that among primary cigar and pipe smokers found a significant association between
premium cigars are safe, which were somewhat elevated 60 minutes primary cigar or pipe smokers and lung
contradicts the available evidence that into a cigar smoking session compared cancer mortality risk, which refutes the
all cigars are harmful and potentially with levels measured after smoking claim that cigar use does not
addictive. In addition, the current abstinence (Ref. 75). Notwithstanding significantly elevate the risk of death. In
population of premium cigar users the small sample size, the study results addition, this study found an
would be left unprotected, potentially still demonstrate that cigars deliver association between COPD mortality
decreasing the likelihood that they nicotine to users. risk and secondary cigar or pipe
would quit, and leading more youth and Similarly, the Funck-Brentano et al. smoking (but not for primary cigar and
young adults to initiate use of premium study (Ref. 74) assessed biomarkers of pipe smoking). Also, contrary to the
cigars or substitute products. tobacco exposure and toxicity in a small assertions of commenters, a recent
(Response) FDA agrees with these sample of cigar (corona-sized or larger systematic review of cigar smoking and
comments. Accordingly, FDA has cigar) or pipe smokers (n = 30), cigarette mortality summarized the results of 22
selected Option 1 deeming all cigars, smokers (n = 28), and nontobacco users published studies from 16 different
rather than a subset, for the scope of this (n = 30), making this small biomarker prospective cohorts and found that
final rule. study less persuasive. In fact, the study primary cigar smoking was associated
(Comment 86) Many comments that authors state: ‘‘These results should not with increased risk of mortality from all
supported Option 2 argued that be seen as a justification for the smoking causes, several types of cancers,
premium cigars do not present a public of pipes and cigars, which are clearly coronary heart disease, and aortic
health threat significant enough to associated with clinically significant aneurysm (Ref. 82). Mortality risks were
warrant regulation and that no evidence health hazards. We emphasize that we greater with increasing number of cigars
was presented that regulation of cannot determine whether our results smoked per day and self-reported level
premium cigars would substantially are explained by the type of tobacco of inhalation, however, primary cigar
improve the public health. These smoked or by the different inhalation smokers reporting no inhalation still
comments stated that premium cigars pattern in pipe/cigar smokers and had highly elevated mortality risks for
represent a small portion of the tobacco cigarette smokers.’’ oral, esophageal, and laryngeal cancers
product and cigar markets (annual A recent analysis of biomarkers of (id.). In addition, a recent study
premium cigar estimate in the United tobacco exposure among cigar smokers estimated that in 2010 more than 9,000
States of 300 million units compared to used data from the 1999–2012 National premature deaths annually were
nearly 14 billion total cigar units and Health and Nutrition Examination attributable to regular cigar smoking
nearly 300 billion cigarettes) (Ref. 73), Survey, a nationally representative (i.e., those who reported smoking cigars
and there is no evidence that premium survey (Ref. 81). The sample included on at least 15 of the past 30 days) (Ref.
cigars have the same health more than 220 primary cigar (i.e., 68).
consequences or habitual use patterns as current cigar/never cigarette) smokers Moreover, FDA reviewed a study by
other tobacco products. They generally and more than 180 secondary cigar (i.e., Boffetta et al. (Ref. 78), which
relied on two studies, Funck-Brentano current cigar/former cigarette) smokers commenters relied upon to claim that a
et al. and Turner et al., to claim that (id.). The researchers found that serum very small number of cancer cases
premium cigars deliver little nicotine to cotinine concentrations among primary existed among cigar smokers and,
users, by inhalation or oral absorption (and secondary) cigar smokers were therefore, premium cigars should not be
(Refs. 74, 75). They also claimed that substantially higher than in nontobacco regulated. The Boffetta et al. study (id.)
cigars do not significantly elevate the users in crude and adjusted analyses used a case-control design to assess the
risk of addiction or death (Refs. 76, 77) (id.). In addition, adjusted analyses association between lung cancer risk
and stated that, in some studies, there showed that concentrations of NNAL (4- and cigar smoking. The authors
were a very small number of cancer (methylnitrosamino)-1-(3-pyridyl)-1- determined that the overall association
cases or deaths among cigar smokers butanol), blood cadmium, and lead were between primary cigar or cigarillo
(Refs. 78, 79). They also noted the also higher among primary (and smokers and lung cancer was significant
nonsignificant odds ratios for those secondary) cigar smokers compared and found significant associations in all
consuming 1 to 2 cigars per day (Refs. with nontobacco users (id.). Therefore, but one area (id.). For all other
69, 79) and for the risk of lung cancer not only were the cited studies estimates, the results were statistically
and ‘‘tobacco-related cancers’’ among unpersuasive, but this robust and recent significant. We also note that, despite
exclusive cigar smokers (Ref. 80). analysis contradicts those studies. the relatively small number of cancer
(Response) FDA disagrees with these In addition, FDA did not find cases in this study, it is only one part
claims and finds that the cited studies persuasive studies cited in comments of a larger body of evidence that
or critiques are not persuasive. for the proposition that cigars do not demonstrates the increased risk of
Regarding the claim that premium cigars significantly elevate the risk of serious adverse health effects associated
deliver little nicotine to users, the addiction or death. To support this with cigar smoking (Refs. 35, 69, 70, 71,
Turner study (Ref. 75) was a study of proposition, comments relied in part on 72, 77, 79, 83).
only 10 male hospital workers a study (Ref. 76) in which a panel (Comment 87) Some comments stated
conducted more than 30 years ago. The scored the worldwide harmfulness of 12 cigar smokers are not at risk of
findings of the Turner study, based on nicotine products using a multicriteria becoming addicted to tobacco products
carboxyhemoglobin and plasma nicotine decision analysis approach. Although based on their use of cigars. Other
levels, suggested that former cigarette cigarettes ranked higher than either comments stated that certain attributes
smokers who occasionally smoked little cigars and other cigars on an of premium cigars increase the
cigars or regularly smoked pipes had aggregate harm score, the study found likelihood for nicotine dependence,
greater cigar smoke inhalation and cigar smoking does result in morbidity, including their size, the amount of
absorption than primary cigar and pipe mortality, and dependence. tobacco (and, therefore, nicotine) in the
smokers (i.e., those who never smoked The other study used to support the cigar, and the longer amount of time
cigarettes). This study also reported that proposition that cigars are not a that it takes to smoke the cigar.
Additionally, these comments suggested document. Thus, the contention that significantly increasing their health
that because cigar tobacco is more studies are inconclusive about the risks (Refs. 33, 91, 92, 93, 94).
alkaline than cigarette tobacco, nicotine health effects of premium cigars because (Response) FDA agrees. Given the
may be absorbed into the blood stream they do not differentiate between types adverse health effects of all cigars, FDA
more rapidly, even without inhaling of cigars is not persuasive. has selected Option 1 deeming all
(Refs. 84, 85). All cigar use is harmful and cigars, rather than a subset, for the scope
(Response) FDA agrees that all cigars potentially addictive. Cigar smokers of this final deeming rule.
are potentially addictive. As discussed have an increased risk of oral, (Comment 90) Some comments raised
in the preamble to the NPRM, a cigar esophageal, laryngeal, and lung cancer concerns about dual and polyuse of
can contain as much tobacco as a whole compared to nonsmokers (Refs. 35, 69). cigars and other tobacco products,
pack of cigarettes, and nicotine yields Among those who report inhaling cigar which is common among both adults
from smoking a cigar can be up to eight smoke, there are significantly elevated and youth (Refs. 90, 95). For example,
times higher than yields from smoking levels of many types of cancer and other in one study, 35.1 percent of adult
a cigarette (79 FR 23142 at 23154). health effects, such as increased risk of premium cigar users, 58.3 percent of
Although the amount of nicotine taken heart and pulmonary disease (Refs. 69, cigarillo and other mass market cigar
in by a cigar user depends on various 70). Cigar smokers also have a marked users (i.e., those reporting their usual
factors like how long the person smokes increase in risk for COPD and cigar did not have a filter and the usual
the cigar, the number of puffs taken, and experience higher mortality risk from brand was not premium), and 75.2
the degree of inhalation, a leading COPD than nonsmokers (Refs. 70, 71). In percent of little filtered cigar users also
review of the science of cigar smoking addition, cigar smokers have a higher smoked cigarettes (Ref. 90). Some
concluded that ‘‘[c]igars are capable of risk of fatal and nonfatal stroke than comments noted that multiple product
providing high levels of nicotine at a nonsmokers (Ref. 72). All cigars produce use is concerning because polytobacco
sufficiently rapid rate to produce clear secondhand smoke, which causes users are more likely to report
physiological and psychological effects negative health effects such as heart symptoms of nicotine dependence (Ref.
that lead to dependence, even if the disease and lung cancer in bystanders 88).
smoke is not inhaled’’ (Ref. 35). In (Refs. 35, 69).
We note that the Surgeon General (Response) As FDA stated in the
addition, regardless of whether
reported in 2014 that, ‘‘[c]ompared with NPRM, we are concerned about the use
premium cigar smokers inhale, buccal
persons who smoke cigarettes, smokers of multiple products, especially
absorption of nicotine does occur, and
who smoke pipes or cigars exclusively combusted tobacco products.
cigar smokers may also absorb nicotine
through the lips due to the alkalinity of have a lower risk for many smoking- B. Youth and Young Adults Use
cigar tobacco (Refs. 86, 87). This related diseases (internal citation Premium Cigars
increased nicotine yield and absorption omitted). Smoke from pipes and cigars
contains the same toxic substances as Proponents of Option 2 have stated
increases the risk of nicotine addiction
cigarette smoke, but those who use a that an exemption for premium cigars is
from cigar smoking. Researchers
analyzing data from the NYTS found pipe or cigar usually smoke at a lower warranted because youth prefer
that although the percentage of youth frequency; observation indicates that machine-made cigars (as opposed to
reporting various measures of they tend not to inhale the smoke, thus hand-rolled) given their low price,
dependence was lower for cigars than reducing their exposure to its toxic flavoring, and easier availability.
for cigarettes or smokeless tobacco, substances (internal citations omitted). However, although youth and young
some youth did report some measures of Evidence indicates that former cigarette adults have a higher use of cigarillos
cigar addiction (Ref. 88). This study smokers are more likely to inhale pipe and other mass market cigars, studies
found that 6.7 percent of middle and or cigar smoke than are primary pipe indicate that they are also using
high school students who only smoked and cigar smokers who have never premium cigars.
cigars also reported strong cravings for smoked cigarettes (internal citations (Comment 91) Many comments cited
a tobacco product during the past 30 omitted)’’ (Ref. 9 at 428–429). However, data showing that among those age 12
days, and 7.8 percent reported research indicates that most cigar and older, past month cigar use
sometimes/often/always feeling irritable smokers do inhale some amount of decreased slightly from 5.4 percent in
or restless when not using tobacco— smoke, even when they do not intend to 2002 to 5.2 percent in 2012 after
which are measures of dependence (id.) inhale, and are not aware of doing so peaking at 5.7 percent in 2004 (Ref. 89
We note that the Surgeon General has (Refs. 32, 33). at Figure 4.1). Among youth only (ages
found that all forms of nicotine delivery Finally, FDA specifically sought 12 to 17), cigar smoking prevalence
do not pose an equal risk in establishing comment on how the potential different declined between 2004 (4.8 percent) and
or maintaining nicotine addiction (Ref. patterns of use for premium cigars might 2012 (2.6 percent) (Ref. 89 at Figure 4.1).
9). result in different or decreased health Trend data from the National Youth
(Comment 88) Many comments impacts, but no such evidence was Risk Behavior Survey also indicate that
remarked that premium cigars do not submitted (see discussion in section cigar use among male high school
pose the same adverse health effects as VII.C of document). students, female students, and white,
cigarettes and other types of cigars (Comment 89) Some comments black, and Hispanic students either
because most studies of cigar health indicated that many cigar users, declined or remained stable from 1997
effects do not differentiate between including those who smoke premium to 2011 (Ref. 9). Additionally, from 1997
types of cigars. They claimed this lack cigar brands, are also current or former to 2013, ‘‘a significant linear decrease
of evidence precludes conclusions about cigarette users, increasing their occurred overall in the prevalence of
the health effects of premium cigars exposure to toxic constituents and the current [youth] cigar use (22.0 percent–
specifically. health risks of using combusted tobacco 12.6 percent)’’ (Ref. 96), which was
(Response) The science is clear that products (Refs. 89, 90). Additionally, observed from data collected by the CDC
cigar use of all types can lead to they stated that these users are more 1997–2013 YRBS (Ref. 29). Accordingly,
negative health effects, as discussed likely to inhale when they use cigars they questioned whether FDA should be
throughout this section of the and may smoke more cigars per day, regulating cigars.
Other comments included data general terms and, therefore, may not day, some days, or rarely, indicated the
indicating that youth cigar use has not report their cigar use (Refs. 98, 100). cigar they usually smoked on those
declined when compared to use of other When examples of brand names were occasions was a premium cigar (id.),
tobacco products. They noted that many added to the 2012 NYTS, there was a which clearly illustrates that young
youth surveys show youth cigar pronounced increase from 2011 in adults are using premium cigars.
smoking to be higher than, or about the reported cigar smoking among non- Although some comments questioned
same as, cigarette smoking. For Hispanic black females (Ref. 100). the applicability of the NATS data on
example, in 2013, among U.S. high Among NYTS high school students premium cigar use by youth and young
school males, the prevalence of current overall from 2000 to 2011, there was no adults (in part, because the study did
(past 30 day) cigar smoking (16.5 change in prevalence of cigar smoking not use the proposed definition of
percent) was comparable to current (Ref. 101). This lack of decline in cigar ‘‘premium cigar’’ in the NPRM), FDA is
(past 30 day) cigarette smoking (16.4 smoking is a concern considering not persuaded. FDA does not believe it
percent) (Ref. 96). Additionally, in 21 cigarette smoking among high school is necessary for the definition of
U.S. cities that conducted the 2013 students did significantly decline over premium cigars in this study to match
YRBS, the prevalence of current cigar these periods (id.). Among NYTS high exactly the definition in the NPRM in
smoking (8.6 percent) was comparable school students overall from 2011 to order to draw inferences about the use
to current cigarette smoking (7.7 2014, there was a decrease in prevalence of different types of cigar products.
percent) among high school students of current use of cigars from 11.6 These data, along with the NSDUH and
(id.). In 2014, NYTS reported that percent to 8.2 percent (Ref. 22). Nielsen market scanner data discussed
among high school Non-Hispanic black (Comment 92) The comments were previously, clearly indicate that youth
students, 8.8 percent reported smoking divided as to whether youth use and young adults are using premium
cigars in the past 30 days, whereas 4.5 premium cigars. Some comments cigars.
percent reported smoking cigarettes in provided data demonstrating youth use Some comments stated the previously
the past 30 days (Ref. 22). In addition, of premium cigars. Others submitted mentioned studies show only minimal
among high school males overall, the mainly informal industry surveys and premium cigar use by minors. By
prevalence of past 30 day cigar smoking anecdotal evidence illustrating that the contrast, they relied on Soldz et al. (Ref.
(10.8 percent) was comparable to past majority of premium cigar users are 102), which examined preferred cigar
30 day cigarette smoking (10.6 percent) older adult males who smoke brands based on a survey of
(id.). Measures of youth use of cigars infrequently and often in a celebratory Massachusetts middle and high school
may underestimate prevalence due to nature. A few other comments stated students. Although the study did not
incorrect self-identification as a non- that patterns of use studies are include any particular premium cigars
cigar smoker and confusion between the inconclusive, because many studies do among the brands reported, 16.4 percent
various cigar products (Refs. 97, 98, 99). not differentiate between premium of youth cigars users were categorized as
Accordingly, the comments supported cigars and mass-market cigars. preferring a ‘‘non-listed’’ brand which
FDA’s regulation of all cigars. (Response) Although youth and young the authors suggested ‘‘may largely
(Response) FDA remains concerned adults tend to smoke mass market cigar consist of premium cigars.’’ The authors
about the use of all tobacco products, brands, they are also using premium based this determination given the
particularly combusted tobacco cigars. In one study, researchers used participants’ positive association
products like cigars and cigarettes, and data from the 2010–2011 NSDUH and between the ‘‘non-listed’’ brands and
remains most concerned about use by Nielsen market scanner data to define a parental cigar use and the negative
youth and young adults given their study sample consisting of 6,678 past association between the listed cigar
unique susceptibility to the 30-day cigar smokers who reported brands and parental cigar use.
addictiveness of nicotine. Although smoking a usual brand of cigars (Ref. Consequently, FDA does not believe this
supporters of Option 2 relied upon 59). While many youth identified a mass study demonstrates that youth do not
NSDUH data showing a decline in cigar market cigar as the brand they used use premium cigars. These comments
smoking prevalence among individuals most often, this analysis reveals that 3.8 also did not provide persuasive peer-
aged 12 to 17 from 2004 to 2012, the percent of youth aged 12 to 17 and 12.1 reviewed evidence indicating that youth
NSDUH’s questions about ever and past percent of young adults aged 18 to 25 and young adults do not use these
30-day use of cigars did not include also identified certain premium cigars to products. In addition, comments stating
examples of specific brands. We note be the brand they smoked most often that youth and adult cigar use studies
that the Surgeon General’s 2014 report (id.). Individuals in both cohorts are not conclusive with regard to
states that ‘‘data from the 1997–2011 reported at least eight different premium premium cigars because they do not
obtained from the National YRBS cigar brands among the brands they differentiate between cigar types are not
indicate that current cigar use among used most often, providing evidence persuasive. Such studies show that
male high school students declined that youth and young adults are youth and young adults smoke cigars,
from 1997–2005 and then remained smoking premium cigars (id.). and other studies that do differentiate
stable from 2005–2011. Among female One study analyzing data from the between product types, such as those
students, current cigar use declined 2012–2013 National Adult Tobacco previously discussed, indicate that
from 1997–2011.’’ (Ref. 9 at 736, Survey (NATS), with 60,192 youth and young adults do, in fact, use
internal references omitted). The 2013 participants 18 years and older found premium cigars.
YRBS, a nationally representative that of those smokers whose type of In light of the health risks associated
survey of 13,000 youths, indicated that cigar could be identified based on the with the use of all types of cigars, FDA
cigar use prevalence trends have attributes of their usual product (e.g., has selected Option 1 and is deeming all
decreased from 1997–2013 for youth in premium cigar smoker, little cigar cigars, including premium cigars, in this
grades 9 through 12 (22 percent in 1997 smoker, cigarillo smoker), 19.9 percent rule.
to 12.6 percent in 2013) (Ref. 29). were premium cigar smokers (Ref. 90). (Comment 93) A few comments
Evidence suggests that some youth More specifically, 15.1 percent of cigar disagreed with FDA’s characterization
may recognize the brand of cigar they smokers aged 18 to 29 years old, who of one study cited in the NPRM (Ref.
smoke, but not that it is a ‘‘cigar’’ in identified themselves as smoking every 103) for the proposition that young
adults often mistakenly view non- would eliminate characterizing flavors 69, 75). They also indicated that
cigarette tobacco products, such as in all cigars including cigarillos and premium cigar use does not lead to
cigars, as safe alternatives to cigarettes. little cigars. addiction. Finally, some comments
They noted that most young adult (Comment 96) Some comments noted that occasional cigar users have
participants in the study rated shisha, argued that premium cigars do not pose not been studied in epidemiological
herbal cigarettes, and herbal smokeless youth access issues because research, and data for the lowest level
as ‘‘safer than cigarettes,’’ but rated manufacturers and retailers do not of cigar users (one to two cigars per day)
cigars and kreteks as more harmful. market them to youth (i.e., they are not do not reveal mortality rates that are
(Response) Many consumers believe cheap, candy- and fruit-flavored, or easy significantly different from nonsmokers
that noncigarette tobacco products, to access) and age verification is already (Refs. 69, 79). However, other comments
including cigars, are less harmful than required at the point of sale limiting included evidence suggesting increased
cigarettes. Although the overall study access to adults only. They relied, in disease risk and nicotine dependence
population did rate cigars as more part, on FDA’s statements in the 1996 among infrequent cigar users and those
harmful, there were subgroups (such as tobacco youth access rule in which FDA reporting they do not inhale.
African Americans and non-Hispanic stated there was insufficient evidence of (Response) FDA disagrees that
whites) that rated cigars from ‘‘a little youth cigar use to warrant cigar patterns of use preclude premium cigar
safer’’ to ‘‘much safer.’’ Deeming all regulation (61 FR 44396). The comments users from experiencing the negative
tobacco products, including premium stated there is no evidence that the health effects of these products. All
cigars, to be subject to chapter IX of the situation has changed since then and cigars produce toxic cigar smoke (Refs.
FD&C Act will help to alleviate that exempting premium cigars from 35, 69). In addition, studies have shown
mistaken beliefs that certain tobacco tobacco product regulation is also that cigar smoking can cause several
products are safe alternatives to warranted because youth do not use different types of cancer even without
cigarettes by virtue of the fact that they premium cigars to any significant inhalation (Refs. 69, 104). For example,
are not subject to FDA regulation. degree. one study found an increased risk in
(Comment 94) A few comments also (Response) FDA disagrees. The head and neck cancers in people who
stated that premium cigar use among Agency’s statement regarding the were not cigarette smokers but had
young adults is irrelevant because availability of evidence to support cigar previously smoked only cigars (Ref.
Congress did not task FDA with regulation was made 18 years ago and 104).
protecting young adults who are based on the evidence available at that While inhaling cigar smoke poses
lawfully permitted to purchase tobacco time. In fact, FDA explicitly stated that much higher morbidity and mortality
products. there was insufficient evidence to rates than not inhaling, significant risk
(Response) FDA is concerned with regulate cigars ‘‘at this time’’ (i.e., 1996) still exists for those who do not inhale.
tobacco use by all age groups, including (61 FR 44396 at 44422). Moreover, the Researchers found that the risk of
young adults and adults who may 1996 rule was issued under the stomach cancer mortality was
lawfully purchase these products. The authority of the FD&C Act prior to the significantly higher among cigar users
Tobacco Control Act charges FDA with passage of the Tobacco Control Act. who reported they did not inhale when
protecting the public health generally, Consequently, one of the reasons FDA compared to those who did not use
not only the health of minors (section 3 did not assert jurisdiction over cigars in tobacco products (Ref. 105).
of the Tobacco Control Act). the 1996 rule was because it did not Additionally, among primary cigar
Nevertheless, FDA is particularly have sufficient evidence ‘‘that these smokers reporting that they do not
concerned with tobacco use by youth products satisfy the definitions of drug inhale, relative mortality risk was still
and young adults, as they are uniquely and device in the act’’ (61 FR 44396 at highly elevated for oral, esophageal, and
more susceptible to becoming addicted 44423). Cigars, including premium laryngeal cancers (Ref. 83). A recent
to nicotine than adults or older smokers. cigars, clearly do satisfy the definition systematic review of cigar smoking and
As discussed in the NPRM, most of a ‘‘tobacco product’’ and evidence has mortality summarized the results of 22
tobacco users begin using prior to the become available since 1996 indicating published studies from 16 different
age of 18 and believing they will be able that youth and young adults use cigars, prospective cohorts and found that
to quit. However, most youth are unable including premium cigars (Refs. 59, 68, primary cigar smoking was associated
to stop tobacco use once they become 90). with increased risk of mortality from all
addicted. Accordingly, FDA is taking causes, several types of cancers,
steps to reduce the potential harm to C. Patterns of Use Do Not Preclude coronary heart disease, and aortic
youth and young adults from tobacco Users From Experiencing Negative aneurysm compared to nonsmokers
products. Health Effects (Ref. 82). Mortality risks were greater
(Comment 95) Many comments Proponents of Option 2 claimed that with increasing number of cigars
expressed concerns regarding flavored patterns of use preclude premium cigar smoked per day and self-reported level
cigars, including flavored premium smokers from experiencing the negative of inhalation; however, primary cigar
cigars, and their effect on youth health effects of tobacco smoke because smokers reporting no inhalation still
initiation. Some comments concluded they smoke infrequently and do not had highly elevated mortality risks for
there is no evidence that minors inhale. However, despite our explicit oral, esophageal, and laryngeal cancers
consume flavored premium cigars, requests in the NPRM, the comments compared to nonsmokers (id.). In
relying on one study in which the did not include data indicating that addition, even if they do not intend to
flavored premium cigar brands of youth premium cigar smokers are not subject inhale and are not aware that they are
use accounted for only a fraction (0.1 to disease risk and addiction. FDA’s doing so, most cigar smokers do inhale
percent) of the less than 4 percent responses to comments regarding these some amount of smoke (Refs. 32, 34).
reported use of premium cigar brands issues are included as follows. Although studies indicate that some
(Ref. 59). (Comment 97) Many comments stated cigar smokers may absorb less tobacco
(Response) FDA is announcing that it that a majority of cigar users are smoke, they also show that all cigar
intends in the future to issue a proposed occasional smokers (two to six cigars smoking is harmful. Regardless of
product standard that, if finalized, per week) and do not inhale (citing Refs. whether cigar smokers inhale, they are
still subject to the addictive and other changed their roll-your-own product to patterns, manufacturing, and
adverse health effects of the product classify it as pipe tobacco to take ingredients across the product category.
through absorption of nicotine and advantage of positive tax treatment, Other comments, however, urged FDA
harmful constituents (Refs. 32, 81). manufacturers would seek similar ways to broadly regulate all cigars in the same
(Comment 98) Supporters of Option 2 to circumvent regulations and continue way to reduce initiation and current use
claimed that premium cigar smokers use marketing products that are detrimental among youth. More specifically,
cigars less frequently than cigarette and to public health. comments advocated prohibiting
smokeless tobacco users and, therefore, (Response) Because FDA has selected flavors, including menthol, in all cigars,
premium cigars should either not be Option 1 deeming all cigars, rather than prohibiting self-service displays, and
regulated or should be subject to less a subset, for this final rule, these establishing minimum pack size
regulation. They relied upon a study comments are moot. requirements for all cigars.
showing that the adult prevalence of (Comment 100) Many comments (Response) Although the statute does
everyday or occasional use of cigarettes stated that it is important for FDA to not require FDA to make any public
was 18 percent and 2.6 percent for regulate all tobacco products, including health finding in order to deem tobacco
smokeless tobacco products, compared cigars, pipe tobacco, and e-cigarettes in products, the Agency has determined
to 2 percent for cigars, cigarillos, and the same way, and that the Agency that cigar use presents health risks and
little filtered cigars (Ref. 106). should ensure that a consistent set of that all cigars should be brought under
(Response) Although the prevalence regulatory criteria is applied to all its regulatory authority. However, FDA
of cigar smoking in the U.S. population tobacco products and nicotine delivery is providing a compliance policy that
is lower than cigarette smoking, use of systems. According to the comments, will provide additional time for
cigars still presents health risks. failure to regulate all tobacco products manufacturers of newly deemed
Researchers estimate that regular cigar would provide incentives for products to comply with certain
smoking was responsible for manufacturers to market new tobacco- requirements, and which will reduce
approximately 9,000 premature deaths based or tobacco-derived products that the burdens on manufacturers as they
or almost 140,000 years of potential life are unregulated and may induce people become regulated by FDA for the first
lost among adults 35 years or older in to switch to the unregulated products.
time. As explained elsewhere in this
2010 (Ref. 68). As stated in the previous (Response) FDA agrees that it is
document, FDA is announcing that it
response, all cigars produce toxic cigar appropriate for the protection of the
public health to regulate all tobacco- intends in the future to issue a proposed
smoke (Refs. 35, 69). Any cigar use
derived products meeting the definition product standard that would eliminate
exposes the mouth and throat to tobacco
of ‘‘tobacco product.’’ There is inherent characterizing flavors in all cigars
smoke and studies have shown that
risk in all tobacco-derived products. including cigarillos and little cigars.
cigar smoking can cause several
different types of cancer even without Further, the Agency agrees that use (Comment 103) Some comments
inhalation (Refs. 69, 104). Health risks patterns may change (and have changed) supporting Option 2 argued that FDA is
still exists for those who do not inhale. over time and in response to regulation. not obligated to deem all tobacco
For example, researchers found that the (Comment 101) At least one comment products that meet the statutory
risk of stomach cancer mortality was expressed concern that FDA relied upon definition of ‘‘tobacco product.’’ They
significantly higher among cigar users an abstract presented at the Conference also stated that the intent of the Tobacco
who reported they did not inhale when for the Society for Research on Nicotine Control Act was to target tobacco
compared to those who did not use and Tobacco (SRNT) as a basis for products marketed to children and
tobacco products (Ref. 107). proposing Option 1. The comment products that cause addiction, which is
Additionally, among primary cigar stated that because the abstract was not why ‘‘cigarette’’ and ‘‘little cigar’’ were
smokers reporting that they do not a full peer-reviewed research article, specifically defined in the Tobacco
inhale, relative mortality risk was still stakeholders were unable to adequately Control Act and large and premium
highly elevated for oral, esophageal, and respond to the claims made. cigars were not similarly defined. Thus,
laryngeal cancers (Ref. 83). Therefore, (Response) FDA disagrees. Additional they claim exempting premium cigars is
all cigars expose users to toxic and analysis of the data that was the subject consistent with Congress’ intent that
cancer-causing substances and increase of this SRNT abstract was conducted premium cigars not be regulated, which
the risk of harm. Basing an exemption and a paper was published and they state is further evidenced by
for premium cigars on current use submitted to the docket, allowing for introduction of such legislation in
patterns would be inappropriate given stakeholders to comment on it (Ref. 90). Congress.
that patterns may change over time and The abstract presented at SRNT also was (Response) FDA agrees that the
in response to regulation. Consequently, not the sole basis for proposing Option Agency is not obligated to deem all
FDA has concluded that deeming all 1. FDA appropriately characterized this tobacco products but disagrees with
cigars, including premium cigars, is as preliminary data and included comments purporting to explain
appropriate for the protection of the additional data and information to Congress’ intent to only regulate
public health. support this proposed option. In products marketed to children. The
addition, FDA has supplemented the purpose of the Tobacco Control Act was
D. Responses to Other Cigar Comments information and data supporting Option to provide authority to FDA to regulate
(Comment 99) Some comments 1, as discussed in section VII, to provide tobacco products and protect not only
expressed concern that if FDA did not additional evidence of premium cigar the health of minors, but also the health
deem all tobacco products subject to use by youth and young adults and to of the public overall (section 3 of the
regulation, the tobacco industry would illustrate that the patterns of use for Tobacco Control Act). While use of
adjust its products to fit the exemption premium cigars do not preclude users tobacco products by youth was and
for premium cigars in Option 2 and from negative health effects. continues to be a significant focus of the
preferential economic treatment of (Comment 102) Comments urged FDA law, it is clear that Congress did not
certain manufacturers would result. to adopt a category-specific approach to intend that the Tobacco Control Act
These comments argued that just as regulation of cigars in order to more reach only products marketed to
manufacturers of roll-your-own tobacco effectively address the variations in use children, as they included many
provisions applicable to tobacco the 3-year HPHC reporting compliance operated, vintage machine-made cigars.
products marketed to adults. period. As noted elsewhere in this Comments stated such cigars are
(Comment 104) Many comments document, FDA does not intend to indistinguishable from handmade
expressed concern that premium cigar enforce the reporting requirements for premium cigars, are sold on the same
regulation would impose considerable newly deemed products before the close shelves as premium cigars, and do not
costs and place excessive burdens on of the 3-year compliance period, even if resemble mass-market cigars. The
small businesses without quantifiable the guidance is issued well in advance comments further argued that
benefits. In particular, many comments of that time. In addition, as discussed in consumers perceive them to be just like
stated that premarket review would be section IV.D, FDA is announcing a value-priced handmade cigars and
cost-prohibitive for premium cigar compliance policy for small-scale treating them differently would create
manufacturers, effectively eliminating tobacco product manufacturers (which significant enforcement issues for FDA.
their ability to release special editions likely would include premium cigar They stated that, without an exemption,
and seasonal blends. They also claimed manufacturers), which states that FDA manufacturers of these products would
that HPHC testing and reporting and generally intends to grant small-scale be forced to close and eliminate jobs,
other regulatory requirements like the tobacco manufacturers additional time negatively impacting the regional
prohibition on free samples would be to respond to SE deficiency letters and economy where such cigars are
equivalent to a de facto ban on premium to not bring enforcement action against produced.
cigars. They also expressed concern those small-scale tobacco product (Response) As already stated, FDA has
about the political and economic impact manufacturers who submit ingredient selected Option 1 deeming all cigars,
of premium cigar regulation on two lists within 12 months of the effective rather than a subset, for this final
foreign nations given the potential date of the rule, and is granting these deeming rule. Therefore, all cigars,
impact on production and exports of manufacturers an additional six-month including hand-operated, vintage
their premium cigars to the United compliance period for the requirements machine-made cigars, are deemed and
States. to submit tobacco health documents. subject to the requirements of chapter IX
Some comments also argued that an FDA believes that this compliance of the FD&C Act and implementing
exemption for premium cigars is policy will help to assist these regulations. Concerns noted by some
appropriate, because premium cigars are manufacturers with regulatory comments about the burdens of
unique in the way that they are made, compliance. regulation are addressed in sections
marketed, sold, purchased, and used. FDA also understands concerns from IV.C and IV.D.
They stated that regulation would stifle cigar retailers about the effect that a ban (Comment 106) At least one comment
innovation in the premium cigar market, on free samples could have on their expressed concern that retailers may not
devastate a long-time social and cultural ability to promote new products. FDA be able to determine whether a cigar
phenomenon, and limit the freedoms of wishes to clarify that allowing meets all of the elements of the final
businesses and consenting adults to sell prospective adult buyers to smell or definition of a ‘‘covered cigar.’’
and purchase a legal product. handle a cigar is not considered the Therefore, the comment stated that
(Response) FDA understands these distribution of a ‘‘free sample’’ for the retailers should not be liable for a
concerns. The Agency has determined purpose of 21 CFR 1140.16 as long as manufacturer’s improperly labeled
that cigar use presents health risks and the product is not actually consumed in premium cigars (similar to the retailer
that all cigars should be brought under the retail facility and the prospective ‘‘safe harbor’’ for required warning
its regulatory authority. buyer does not leave the facility with a labels and advertising in the proposed
To assist newly regulated firms, FDA free tobacco product (whole or part). cigarette graphic warning rule (75 FR
is announcing in this final rule a Affording adult consumers the 69524 at 69535, November 12, 2010)).
compliance policy to address some of opportunity to handle the product will (Response) FDA has selected Option
the possible burdens suggested by give them the ability to feel the 1, which requires all cigars (rather than
comments (section IV.D). For example, resistance of the cigar’s structure, and a subset) to include the textual health
FDA does not intend to enforce the allow them to clearly see the color of the warnings. FDA also notes, however, that
premarket review requirements against product, which is an indication of the § 1143.5(a)(4) does provide a retailer
cigar manufacturers that make tobacco fermentation period for the tobacco. It ‘‘safe harbor’’ for required warning
blending changes to address the natural also will allow users to capture the labels for packaging that contains a
variation of tobacco (e.g., tobacco aroma of the cigar and the box (if the health warning; is supplied to the
blending changes due to variation in cigar is sold in a package). Therefore, it retailer by a manufacturer, importer, or
growing conditions) in order to would not be considered a free sample distributor who has the required state,
maintain a consistent product. However, if a prospective buyer smells the cigar local, or Alcohol and Tobacco Tax and
FDA intends to enforce the premarket while handling it. We believe that in Trade Bureau (TTB)-issued license or
requirements for products that have most circumstances, other retail permit, if applicable; and is not altered
tobacco blending changes (including facilities, including ENDS retail by the retailer in a way that is material
those involved in seasonal and boutique establishments, can similarly allow to the requirements of § 1143.5.
blends) that are intended to alter customers to touch, hold, and smell Retailers must have the required
chemical or perception properties of the their products without violating the free warnings on advertisements as stated in
new tobacco product (e.g., nicotine sample ban. However, if the prospective § 1143.5(b)(1).
level, pH, smoothness, harshness). FDA buyer lights and draws or puffs on the (Comment 107) Some comments
also is working to determine an cigar to keep the cigar lit, or otherwise stated that FDA has the authority to
appropriate compliance policy to deal uses the free cigar or leaves the retail assert jurisdiction over all cigars and
with HPHCs for newly deemed products establishment with a free cigar, this differentially apply regulations to
and is intending to issue guidance would constitute a ‘‘free sample’’ in certain cigars if shown to be appropriate
regarding HPHC reporting, and later a violation of § 1140.16. based on scientific evidence. Thus,
testing and reporting regulation as (Comment 105) Many comments according to the comments, if it were
required by section 915, with enough requested that the exemption for established that premium cigar risk is of
time for manufacturers to report given premium cigars be extended to hand- a different nature and degree than the
risks of other types of cigars based on cigars while others urged regulation of politically biased and that studies that
who uses them and how they are used, them in a manner similar to cigarette oppose tobacco product regulation are
the Agency could apply its authority in papers and roll-your-own tobacco. often prohibited from publication.
a way that fits the risks posed by the (Response) With this final rule, make- (Response) The Delnevo, et al.
product. These comments concluded your-own cigar products, including publication found that youth and young
that because of this, it is unnecessary cigar wrappers and cigar tobacco, are adults are significantly more likely than
and would be inappropriate to tobacco products and subject to FDA’s older adults to prefer cigar brands that
completely exempt premium cigars. tobacco control authorities under are more likely to be flavored (Ref. 59).
Similarly, some comments applied chapter IX of the FD&C Act. Cigar Because no national data directly
the notion of a ‘‘continuum of risk’’ to wrappers containing tobacco or tobacco- compared youth and adult flavored
cigars. They stated that premium cigars derived nicotine and cigar tobacco cigar use within the same study,
are at the lower end of the spectrum packaged and sold individually are also Delnevo and colleagues conducted an
(Ref. 76) due to the common usage subject to the warning requirement for ecological analysis combining data from
patterns (i.e., described as most ‘‘covered tobacco products’’ found in the 2010–2011 NSDUH on cigar brand
frequently used by adults, on special § 1143.3. smoked most often, with Nielsen data
occasions, and users do not inhale). (Comment 110) At least one comment
indicating the percent of the cigar
Therefore, they urged that FDA regulate stated that FDA should not permit
brands’ market share that are labeled as
premium cigars in line with the notion manufacturers to self-classify their
flavored cigar products. These results,
of a continuum of risk. products as cigarettes or cigars, and if
coupled with information on the
(Response) FDA agrees that a premium cigars are exempted, should
prevalence of flavored cigar use from
continuum of nicotine-delivering not permit self-classification of cigars as
studies restricted to youth or to young
products does exist as demonstrated by premium or nonpremium.
the lower levels of toxicants in ENDS in (Response) Regardless of how they adults, provide additional indirect
comparison to cigarettes, and may may be classified by their evidence of the popularity of flavored
warrant different requirements for manufacturers, cigars and cigarettes will cigars among younger cigar smokers as
products at different ends of this be classified based on the definitions compared to older adult cigar smokers.
continuum. However, commenters have included in this final rule. Especially when coupled with research
not substantiated their claims that the (Comment 111) A few comments results on the prevalence of flavored
patterns of use for premium cigars argued that bias existed for any study or cigar use in studies restricted to youth
preclude users from negative health analysis cited in the NPRM that was or young adults, this study provides
effects. Instead, as discussed throughout written or contributed to by FDA additional supporting evidence of the
this section, cigar use poses a greater employees. These comments were widespread appeal of flavored varieties
risk than not smoking, and lack of concerned that FDA employees of these products among young
inhalation do not prevent the onset of generating and analyzing data did so to Americans. The comments noted that,
cigar-related morbidity and mortality. support the proposed regulation of in the 2010–11 NSDUH, 13 percent of
Therefore, FDA has concluded that it is cigars. cigar smokers did not report a usual
appropriate for all cigars to be brought (Response) FDA disagrees. FDA notes cigar brand and expressed concern
under its regulatory authority. that most of the studies cited in the about the ability of those who reported
(Comment 108) Several comments NPRM that were authored by FDA their usual cigar brands to do so
stated that it would be inappropriate employees have been published in peer- accurately. Some cigar smokers may in
and inaccurate for FDA to treat ‘‘cigars’’ reviewed journals. Where the NPRM fact not actually have a cigar brand they
as a single homogenous category or to discussed research results presented at smoke most often and consequently did
simply overlay the existing regulatory a professional conference, SRNT, but not provide a brand response, while
framework for cigarettes onto the not yet included in a peer-reviewed other respondents may have chosen not
diverse suite of deemed products. They journal, FDA clearly stated so and to provide their usual brand
further stated that because of the specifically requested comment (79 FR information. Among the latter group,
significant differences among cigar at 23151). That research has since been missing data is always a concern,
products, it is critical that FDA published (Ref. 90). although there is no evidence from the
distinguish between the specific cigar (Comment 112) Some comments study to suggest that those who
subtypes in determining whether any, criticized the methodologies used by provided brand information were
some, or all cigars should be subject to researchers in studies FDA cited in the systematically different than those who
regulation. If FDA were to do otherwise, NPRM (e.g., Ref. 59). For example, they did not. Additionally, the comments did
they believe the Agency would risk claimed that the Delnevo, et al. study not provide evidence to substantiate the
establishing an arbitrary and capricious, regarding youth use of flavored cigars concern that respondents were not
overly broad regulatory scheme that (id.) was flawed, because the study cites reporting the brand names they actually
fails to meet its burden to protect the any use of the brand by youth as use of used. Lastly, FDA does not agree with
public health without imposing undue the flavored variety of that cigar brand concerns about representativeness of the
burden on the industry. (even though the respondent might use survey. The NSDUH is designed to be
(Response) FDA disagrees. Upon an unflavored variety of that cigar). The representative of the U.S. civilian, non-
review of comments and scientific comments had additional concerns institutionalized population, ages 12
evidence, FDA has determined that all regarding the study, such as missing and older (http://www.samhsa.gov/
cigars present a risk to public health data on cigar brand from 13 percent of data/population-data-nsduh). FDA does
and, consequently, should be deemed. cigar smokers, as well as concerns about not rely on any single study to support
(Comment 109) A few comments whether study participants provided decisions included in this final rule.
discussed different regulatory accurate information regarding cigar FDA cited many peer reviewed studies
approaches for make-your-own cigar brand used, and whether the study in the NPRM and relies upon many
products (e.g., cigar wrappers and cigar population was representative of the peer-reviewed studies to support the
tobacco). At least one comment U.S. population. Other comments stated decisions included in this final rule,
suggested treating these products as that studies in peer-review journals are including the Delnevo publication.
VIII. Regulation of Electronic Nicotine authority under chapter IX of the FD&C are using ENDS as a means to quit
Delivery Systems (Including E- Act. smoking.
Cigarettes) and the Continuum of (Comment 115) Many comments
B. Prevalence contended that the great majority of e-
Nicotine-Delivering Products
In the NPRM, FDA expressed concern cigarette users consist of former smokers
In the preamble to the NPRM, FDA about the increase in prevalence of the and those trying to quit smoking, rather
noted that there are distinctions in the newly deemed products, particularly than those who are initiating tobacco
health risks presented by various the alarming rise in e-cigarette use by use with e-cigarettes (e.g., Ref. 109). The
nicotine-delivering products. FDA middle school and high school students. comments included data from regional
requested comment as to how e- The comments included peer-review surveys indicating that even where there
cigarettes should be regulated based on studies, focus group results, and data has been a significant increase in youth
this continuum of risk. We explained regarding the prevalence of ENDS use. and young adult e-cigarette use, the
that some studies have revealed the (Comment 114) Some comments increase is seen in experimenters and
existence of toxicants in both the e- noted that it was difficult to fully not daily users. For example, a few
cigarette liquid and the exhaled aerosol ascertain prevalence of use of these comments referred to a report
of some e-cigarettes but that we do not products because they are sold under commissioned by Public Health England
have sufficient data to determine what many different names. However, they which referred to a study that found that
effects e-cigarettes have on public health generally agreed that the prevalence of only 1 percent of 16 to 18-year-old never
at the population level. We also noted e-cigarette use has increased in recent smokers have experimented with e-
that some individuals report using e- years, citing peer-reviewed studies and cigarettes and few, if any, progress to
cigarettes to successfully quit smoking, data from state or regional surveys (e.g., sustained use (Ref. 110).
but we expressed concerns about dual Ref. 108). For example, comments cited (Response) Data reported by the CDC’s
use of e-cigarettes and combusted the 2013 North Carolina Youth Tobacco National Center for Health Statistics
tobacco products and the possibility Survey (NCYTS) and expressed concern (NCHS), which provides the first
that flavored e-liquids are leading that, while the current cigarette smoking estimates of e-cigarette use among U.S.
children to initiate tobacco use with e- rates among North Carolina high school adults from a nationally representative
cigarettes. students decreased in recent years, the household interview study, indicate that
In this final rule, FDA clarifies that overall current use of tobacco products current cigarette smokers and recent
although there are many types of ENDS increased from 22.5 percent in 2011 to former smokers (i.e., those individuals
(including e-cigarettes, e-cigars, e- 24.5 percent in 2013. In particular, the who quit smoking within the past year)
hookah, vape pens, personal vaporizers, rate of e-cigarette use increased from 1.7 were more likely to use e-cigarettes than
and electronic pipes), all are subject to percent in 2011 to 7.7 percent in 2013, long-term former smokers (i.e., those
FDA’s chapter IX authorities with this and 2.7 percent of high school students individuals who quit smoking more
final deeming rule. Comments regarding who had never tried a cigarette than one year ago) and adults who had
e-cigarettes, including comments on indicated that they were considering never smoked (Ref. 24). In addition, the
how the products should be regulated in using e-cigarettes in the next year. CDC states that current cigarette
light of this continuum, and FDA’s However, some of these comments smokers who had tried to quit smoking
responses are discussed in the following believed that the data showing an in the past year were more likely to use
sections. increase in e-cigarette use among youth e-cigarettes than those who had not
and young adults only reflects their tried to quit (id.). It is noted that it
A. Terminology experimentation (and not long-term use) cannot be determined by the research
(Comment 113) Some comments and that there are no data showing that findings: (1) Whether former cigarette
expressed confusion as to what is this experimentation leads to long-term smokers who now exclusively use e-
encompassed by the term ‘‘e-cigarette.’’ use or dual use with combusted tobacco cigarettes would have ceased smoking
Other comments stated that the products. Others stated that although e- cigarettes regardless of e-cigarette use;
‘‘electronic smoking devices’’ covered cigarette use may be increasing among and (2) whether the e-cigarette use
under this deeming rule should include youth and young adults, this increase is preceded or followed smoking
e-cigarettes, e-cigars, e-hookah, and due to the fact that young adult smokers cessation. Similar patterns have been
vape pens. are switching to e-cigarettes, as are adult observed in Europe, where researchers
(Response) FDA agrees that electronic smokers. found that ‘‘e-cigarette use was more
nicotine delivery systems or ENDS are (Response) FDA agrees with likely among smokers who had made a
sold under several different names comments stating that the prevalence of past year quit attempt’’ when compared
including e-cigarettes, e-cigars, e- use of the newly deemed tobacco to smokers who had not (Ref. 111). As
hookah, vape pens, personal vaporizers, products has been increasing, which discussed in further detail in response
and electronic pipes. These products all further substantiates the need for this to Comment 144, a meta-analysis of 15
meet the definition of ‘‘tobacco final rule. FDA remains concerned cohort studies, 3 cross-sectional studies,
product’’ and, therefore, under this rule, about the rise in use of newly deemed and two clinical trials (one RCT, one
all are subject to FDA’s tobacco control products by youth and young adults, non-RCT) found that cigarette smokers
authorities, regardless of a novel name particularly the increase in use of ENDS. who also used e-cigarettes had
or heating source. In addition, the As we stated in the NPRM and statistically significantly worse quit
definition of tobacco product includes throughout this document, long-term rates than those cigarette smokers who
components and parts (the objects studies are not yet available to did not use e-cigarettes (Ref. 112).
intended or reasonably expected to be determine whether these youth and However, FDA also remains
used with or for the human young adults are only experimenting concerned about the dramatic rise in
consumption of a tobacco product that with tobacco use, becoming established ENDS use among youth; between 2011
are not accessories) (e.g., e-liquids, ENDS users or dual users, or and 2014, past 30 day e-cigarette use
tanks, cartridges, pods, wicks, transitioning to combusted products. In among high school students increased
atomizers), which, under this rule, have addition, there is not sufficient evidence nearly 800 percent from 1.5 percent in
also been deemed to be subject to FDA’s to conclude that youth and young adults 2011 to 13.4 percent in 2014 (Ref. 22),
and between 2011 and 2013, the number on access to ENDS by minors before flavored e-cigarettes for total mass of
of never-smoking youth who had January 2013, relative to states that did diacetyl, 2,3-pentanedione, and acetoin
reported ever using an e-cigarette not. Given the various issues with this (Ref. 125). Researchers detected diacetyl
increased 3-fold, from 79,000 to more study (see previous discussion regarding above the laboratory limit of detection
than 263,000 youth (Ref. 113). The this publication in response to comment 39 of the 51 flavors tested, ranging from
Surgeon General has stated that 33), FDA acknowledges this paper as a limit of qualification (LOQ) to 239 mg/
adolescents appear to be particularly first attempt to study potential impacts e-cigarette. 2,3-pentanedione and
vulnerable to the adverse effects of of youth ENDS access restrictions, but acetoin were also detected in 23 and 46
nicotine on the central nervous system emphasizes that further research will be of the 51 flavors tested at concentrations
(Ref. 9), and ENDS may deliver as much needed to explore the effects of this rule up to 64 and 529 mg/e-cigarette (id.). It
nicotine as other tobacco products (Ref. on product switching and dual usage. is noted that the study involved a
114). convenience sample of 51 types of
FDA is investing in long-term, C. Toxicity and Nicotine in E-Liquid and
Aerosol flavored e-cigarettes and may not be
population-level research, such as the representative of the types of e-liquids
PATH Study, to help assess the Although FDA noted in the NPRM currently available to users. Absent a
likelihood that previous nonusers of that we do not currently have sufficient regulatory standard, FDA acknowledges
tobacco who experiment with ENDS data about e-cigarettes and similar that it may not be possible to account
will initiate regular tobacco use over products to fully determine what effects for the wide variability of
time. Such longitudinal studies can they have on the public health, we concentrations of constituents in the
further assess the factors associated with identified concerns regarding the flavors of current ENDS products.
potential smoking cessation among e- toxicants in e-liquid and the exhaled Another study analyzed 30 e-cigarette
cigarette users. aerosol and the nicotine delivery from e- liquids and found that many flavors,
(Comment 116) The comments cigarettes. Comments were divided on including cotton candy and bubble gum,
generally agreed that youth are the safety and toxicity of e-liquids, e- contained aldehydes, a class of
increasingly using e-cigarettes, but cigarettes, and the exhaled aerosol. chemicals that can cause respiratory
disagreed as to the product’s impact on (Comment 117) The comments
irritation, airway constriction, and other
nicotine addiction. As FDA noted in the expressed concerns that e-cigarette users
effects (Ref. 126). Specifically,
proposal and as discussed by many subject themselves to dangerous
researchers noted that two flavors, a
comments, the CDC found that ever use constituents, including formaldehyde
dark chocolate and a wild cherry, would
of e-cigarettes by middle and high and other toxicants. One comment
expose e-cigarette users to more than
school students in the United States stated that the release of formaldehyde
twice the recommended workplace
increased from 3.3 percent in 2011 to occurs only when the voltage on e-
cigarettes is set to 4.8 volts or higher safety limit for the aldehydes vanillin
6.8 percent in 2012 (Ref. 108). While the
(Ref. 67). Some comments also and benzaldehyde (id.). Similarly,
majority of comments recognized an
submitted studies showing the existence researchers found that several
increase in dual use, some suggested
of other e-liquid constituents, including cinnamon-flavored e-liquids contained a
that this was not an issue because youth
prescription weight loss and erectile chemical, cinnamaldehyde, which
are using e-cigarettes to quit smoking,
dysfunction drugs (Ref. 117). researchers stated was highly toxic to
resulting in some dual use until they
(Response) Studies show that e-liquid human cells in laboratory tests (Ref.
can completely abstain from
tobacco products contain nicotine, 127).
conventional cigarettes (Ref. 115).
(Response) FDA remains concerned propylene glycol, glycerin, tobacco Some studies have found that lower
about the rise in ENDS use among youth specific nitrosamines, tobacco alkaloids, levels of toxicants are observed in e-
and young adults as well as the trends carbonyls, ethylene glycol, diacetyl, and cigarette aerosols than in combusted
in dual use of ENDS and combusted acetyl propionyl (Refs. 19, 118, 119). tobacco smoke (Ref. 122). FDA
products in both youth and adults (Ref. Chemicals such as nicotine, carbonyls, recognizes that specific product design
116). In addition, as stated in the NPRM tobacco specific nitrosamines, heavy parameters, such as voltage, can affect
and throughout this final rule, all metals, and volatile organic compounds toxicant deliveries (Ref. 67). For
tobacco products are potentially have been identified in e-cigarette example, some ENDS devices and some
addictive and some ENDS may deliver aerosols (Refs. 19, 118, 119, 120, 121, power levels of operating ENDS devices
as much nicotine as other tobacco 122). have been reported to deliver more
products (Ref. 20). The Surgeon General In addition, several studies formaldehyde than other ENDS
has stated that adolescents appear to be substantiated the data included with products and conventional cigarettes
particularly vulnerable to the adverse comments, finding that flavored e- (Refs. 67, 128, 129) and can affect the
effects of nicotine on the central liquids contain chemicals that could be public health. In addition, a 2010 study
nervous system (Ref. 9). FDA believes dangerous to consumers when inhaled. conducted by the Virginia
that this final deeming rule, along with For example, researchers in one study Commonwealth University determined
the minimum age restrictions and health tested 159 e-liquids with sweet flavors, that in a controlled evaluation of
warning requirements, is an important such as toffee, chocolate, and caramel, smokers naı̈ve to the use of e-cigarettes
step toward combatting this rise in and found that almost three quarters of and using a particular model of e-
tobacco product use among youth and the samples (74 percent) contained cigarette, acute effects of using the
young adults. diacetyl or acetyl propionyl (Ref. 123), product did not result in measurable
A recently published paper by both of which pose known inhalation levels of nicotine or carbon monoxide,
Friedman (Ref. 42) looked at youth risks (e.g., Ref. 124). Among those that although e-cigarettes did suppress
smoking rates in states that enacted tested positive, nearly half of the e- nicotine/tobacco abstinence symptom
early bans on sales of e-cigarettes to liquids in the study could expose users ratings (Ref. 130). Moreover, a recent
minors and concluded, based on state- to levels that exceed recommended evaluation of the relative health risks of
level data available through 2013, that workplace limits for breathing these ENDS products conducted by Public
the decline in adolescent smoking rates chemicals (Ref. 123). An additional Health England has drawn attention to
slowed in states that enacted restrictions recent study analyzed 51 types of scientific reviews concluding that ENDS
are ‘‘likely to be much less, if at all, especially formaldehyde, in the vapor reports FDA received from 2007 to 2012,
harmful to users or bystanders’’ and a from some ENDS to exist at levels much which found that only 8 of them were
prior paper that reported the findings lower than in cigarette smoke (Ref. 132). considered serious (e.g., pneumonia,
from an international expert panel of Moreover, across several Japanese congestive heart failure, disorientation,
academics. Employing an analysis brands evaluated by another researcher seizure, hypotension, facial burns, chest
model that quantifies the relative health in a self-published Web site, under pain and rapid heartbeat, infant choking
harms of 12 tobacco products using a some use conditions, ENDS released on an e-cigarette cartridge, loss of
series of 14 harm criteria, the expert 1/50th of the level of formaldehyde vision) (Ref. 138).
panel determined that while cigarettes released by cigarettes (Ref. 135). The Some comments also stated that e-
scored 100 percent in their assessment highest level detected was six times cigarettes provide subjective health
of maximum relative harm, ENDS lower than the level in cigarette smoke benefits to current smokers. For
products were rated to have only 4 (id.). A clinical investigation comparing example, in one Internet survey of 1,347
percent maximum relative harm, which the levels of toxicants and carcinogen current e-cigarette users, among those
contributed to Public Health England’s metabolites in the urine of e-cigarette who were former smokers, 75 percent
assessment that ENDS are around 95 users and combusted cigarette users reported improved breathing, less
percent safer than smoking combusted found that e-cigarette users had coughing, and feeling healthier overall
cigarettes (Ref. 131; see Refs. 76, 132). significantly lower levels of all after switching to e-cigarettes (Ref. 139).
The recent evaluation’s use of the evaluated toxicants, which included They also claimed that e-cigarette use
prior paper has several limitations, and acrolein and crotonaldehyde (Ref. 136). leads to improved sense of smell and
the prior paper itself observed that it But other research, published as a letter taste and general physical status (Ref.
was reporting outcomes based on the to the editor of the New England Journal 109). In addition, they stated that some
decision-conferencing process from a of Medicine, reported that ENDS devices of the harms caused by smoking can be
group of experts who were selected operated at 5 volts delivered a mean of reversed by switching to e-cigarettes
without any ‘‘formal criterion,’’ though 390+/¥90 mg per 10 puff sample which (Ref. 140).
‘‘care was taken to have raters from is greater than 150 mg, the estimated (Response) FDA agrees that the
many different disciplines’’ and average delivery of formaldehyde than majority of reported adverse events
primarily based on geographic location conventional cigarettes. No appear to have been not serious. The
‘‘to ensure a diversity of expertise and formaldehyde-releasing agents were FDA adverse event reporting system has
perspective’’ (Ref. 76). In addition, the detected when ENDS were operated at inherent limitations as a measure of the
authors acknowledge that there is a 3.3 volts (Ref. 128). A subsequent peer- impact of e-cigarettes since ENDS are a
‘‘lack of hard evidence for the harms of reviewed article on 5 variable-power newly deemed product and reporting
adverse events associated with tobacco
most products on most of the criteria’’ ENDS devices found large variations in
products (including e-cigarettes and
(Refs. 76, 133, 134). The authors did not formaldehyde delivery across devices
other ENDS) is voluntary; therefore, the
explain what scientific information was (Ref. 129). The first device yielded more
reports received may have
available to the experts upon which formaldehyde than combustible
underrepresented the true number and
they should base their ratings. The cigarettes at every power level tested,
types of adverse events associated with
authors did not explain the derivation of and the second device delivered more
ENDS. The data cannot be used to
the quantitative assessment of each formaldehyde at the highest power level
calculate incidence (occurrence) rates or
harm criterion. It is unclear if the tested; the remaining three devices
to estimate risk. Moreover, FDA has
authors carried out or referenced a delivered less formaldehyde than
concerns with relying upon the types of
quantitative risk analysis, a standard combustible cigarettes at all power short-term studies provided in the
practice when assessing relative risk, levels tested (id.) The same research comments. Short-term studies fail to
nor did the authors indicate that they found that aldehyde delivery varied by analyze the exposure risk of tobacco use
used mean levels of exposure to HPHCs 750-fold from one ENDS device to and inhalation that damage health over
in users or other quantitative evidence another (id.). The article referenced in a lifetime of repeated, extended
as an approximation of risk. In addition, one comment (Ref. 67) reported that exposure. Given the relatively new
population effects appear to be largely increasing the voltage from 3.2 to 4.8 entrance of ENDS on the market,
outside the scope of this analysis since volts increased formaldehyde, consumers have not had the duration of
the manuscript did not address the acetaldehyde, and acetone levels from 4- use for researchers to fully assess the
likelihood that the characteristics of the fold to over 200-fold. morbidity and mortality effects for
products would make them more or less (Comment 118) The comments in ENDS on either the individual or the
likely to appeal to new users, be used support of limited or no regulation for population.
in conjunction with other tobacco e-cigarettes cited studies showing that e- FDA recognizes that completely
products or discourage quitting. They cigarette use resulted in improvements switching from combusted cigarettes to
did not describe an assessment of in many health indicators of former ENDS may reduce the risk of tobacco-
population effects such as a quantitative cigarette smokers. Most of these related disease for individuals currently
assessment of youth use prevalence. comments relied upon published using combusted tobacco products,
FDA does not find the beliefs reported literature concluding that, despite the given the products’ comparative
in the prior paper (Ref. 76) to be lack of long-term health data, e- placements on the continuum of
sufficiently conclusive on the relative cigarettes are ‘‘likely to be much less, if nicotine-delivering products. A recent
risks of using different tobacco at all, harmful to users and bystanders’’ review from Public Health England
products.14 However, previous studies (Ref. 132). They also noted that clinical (discussed in greater detail in response
detected the presence of aldehydes, studies to date indicate that e-cigarettes to Comment 117) suggests substantial
generally are well-tolerated and do not reductions in the exposure to harmful
14 In addition, at least one source has identified
produce serious adverse events constituents typically associated with
other flaws with the expert panel employed in the
Nutt et al. report, including potential conflicts of
following use for up to 24 months (Refs. smoking in ENDS products compared to
interest and no prespecified expertise on tobacco 107, 137). Many relied upon an analysis cigarettes, and that most of the
control among the panel members (Ref. 133). of the 47 e-cigarette adverse event chemicals causing smoking-related
disease from combusted tobacco use are meaningful is the comparison between research regarding the environmental
absent and the chemicals that are the amount of nicotine delivered to the impacts of e-cigarette use and storage.
present pose limited danger (Ref. 131). user after using a cigarette (or other (Response) FDA is funding studies
A scientific review of published studies conventional tobacco product) versus regarding environmental impacts due to
of the toxicity of certain e-liquids found the amount of nicotine delivered after ENDS manufacturing, use, and disposal
that ‘‘[e-cigarette] aerosol can contain using an ENDS (Ref. 146). Therefore, following use. In addition, FDA has
some of the toxicants present in tobacco even if an e-liquid has the same nicotine been conducting a series of public
smoke, but at levels which are much level, it may deliver a different level of workshops to obtain information on e-
lower. Long-term health effects of [e- nicotine than the comparator product. It cigarettes and their impact on public
cigarette] use are unknown but is also possible that comparable nicotine health. Potential environmental impacts
compared with cigarettes, [e-cigarettes] delivery consistently produced by ENDS were discussed during the first
are likely to be much less, if at all, that meet the requirements of the workshop (79 FR 55815, September 17,
harmful to users or bystanders’’ (Ref. Tobacco Control Act may increase the 2014).
132). ENDS products have been found facilitation of product switching from (Comment 121) Some comments
in some studies to release aldehydes at cigarettes to ENDS—which could (with expressed concern about the health
much lower levels than that in cigarette appropriate regulatory oversight) effects of propylene glycol exposure
smoke, with one Web site posting potentially reduce the overall health from e-cigarette use. They also stated
stating that, across several Japanese harm caused by combusted tobacco. that the use of glycerol and propylene
brands, under some use conditions, that Further research is necessary to glycol, both of which are humectants,
ENDS products release 1/50th the level determine the causal factors that may cause uninformed users to become
of formaldehyde released in cigarettes influence product switching from inadvertently dehydrated.
(Ref. 133). cigarettes to ENDS (or vice versa) and (Response) FDA recognizes that
However, study results have been the subsequent health impacts. information about the health effects of
inconsistent about the effects of these the constituents in e-liquids and ENDS
Second, FDA disagrees with the
products. Some short-term studies aerosols in both users and nonusers is
notion that e-liquids are restricted to the
suggest that ENDs may not affect heart limited and that this issue should be
same level of nicotine as other tobacco
rate, cardiac function, lung function, or explored to better understand the
products. E-liquids are available in a impacts of these products on the
complete blood count indices to the wide range of nicotine concentrations,
extent of conventional cigarettes (Refs. population health.
but delivery to the user is based on (Comment 122) As FDA noted in the
130, 141, 142). A literature search, multiple factors, including the
however, concluded that the current NPRM, one study detected diethylene
humectant in the e-liquid, the glycol in one e-cigarette cartridge (79 FR
scientific evidence on short-term effects temperature to which the e-liquid is
are limited and there are no adequate 23142 at 23157). A few comments took
heated, the user experience, device issue with FDA’s reliance on the study,
data on long-term health effects (Ref.
designs, and design modifications (Ref. because the amount of diethylene glycol
143). Other studies have demonstrated
147). Data suggest that experienced reported was so low that it was unlikely
increase in mean heart rate and
ENDS users are able to achieve to cause harm to consumers and had not
inflammatory measures (such as white
clinically significant nicotine levels and been replicated in other scientific
blood cells) and changes in lung
levels similar to those generated by studies to date.
function after use (Refs. 141, 142, 144,
traditional cigarettes (Refs. 114, 148, (Response) FDA appropriately
145). Some research has found that
149, 150). Moreover, heating the e- characterized this study in the NPRM,
there are some ENDS devices and some
liquids to higher temperatures and using stating that diethylene glycol ‘‘was
power levels of operating ENDS devices
that deliver more formaldehyde than the ENDS in ways other than intended found in only 1 of 18 cartridges studied
other ENDS products and conventional (e.g., dripping the e-liquid directly onto and it was not found at all in another
cigarettes (Refs. 67, 128, 129). Further, the atomizer) may result in nicotine 16 studies’’ (79 FR 23142 at 23157).
the review by Hajek et al. (Ref. 132) delivery that is actually higher than that FDA agrees that the amount found was
referred to in this comment as showing of a conventional cigarette (Ref. 16). low, but reiterates that diethylene glycol
health benefits and finding a lack of Third, FDA disagrees with the is a toxicant and, therefore, is a cause
negative health effects of e-cigarettes, premise that the Agency should not be for concern.
may have limited generalizability due to concerned with tobacco products that (Comment 123) We received many
the variability of e-cigarette products. may have lower nicotine levels than comments regarding the safety of the
The authors expressly recognized that cigarettes or other tobacco products, as aerosol that is emitted from e-cigarettes.
there are many deficiencies in the may be the case with some ENDS. Even These comments expressed concern that
available data. if ENDS products have lower levels of individuals incorrectly believe that the
(Comment 119) Some comments nicotine, they still have the potential to aerosol emitted from e-cigarettes is
believed that FDA should not be addict users, particularly youth and harmless and stated that e-cigarette
concerned about e-liquids because they young adults, as discussed in section aerosol is not simply water ‘‘vapor,’’ as
are restricted to the same nicotine levels VIII.C. As the Surgeon General has is sometimes advertised (Ref. 151). They
as other products (e.g., cigarettes, stated, nicotine is the primary addictive provided studies indicating that the
hookah, smokeless tobacco, NRTs). substance in tobacco products (Ref. 9). primary or mainstream and exhaled or
(Response) FDA disagrees with Regardless of the nicotine content of the secondhand e-cigarette aerosols have
comments stating that the Agency tobacco products, FDA believes that been found to contain at least 10
should not be concerned with ENDS deeming tobacco products will result in chemicals known to cause cancer, birth
use. First, a direct comparison of the significant public health benefits and defects, or other reproductive harm (Ref.
nicotine level in cigarettes (and other that the additional restrictions imposed 65). They also noted that potentially
currently regulated tobacco products) by this rule are appropriate for the harmful constituents have been
with the nicotine level in e-liquids is protection of the public health. identified in some e-liquids and their
not a particularly helpful or relevant (Comment 120) One comment aerosol, including tobacco-specific
comparison. More helpful and clinically expressed concern about the lack of nitrosamines, heavy metals, and
carbonyls, albeit at significantly lower result, directly or indirectly, in its certain types of ENDS do not have
levels than in cigarette smoke (Refs. 65, becoming a component or otherwise consistent quality and the labels may
118, 152, 153, 154, 155, 156). Studies affecting the characteristics of any food not accurately reflect the amount of
have shown that the primary aerosol (section 201(s) of the FD&C Act). nicotine in the e-liquid. The World
contains measurable amounts of E-liquid is not food or intended for Health Organization (WHO) also has
nicotine, which can have an impact on ingestion; therefore, the fact that noted that the level of nicotine
both users and nonusers (Ref. 144, 147). propylene glycol and glycerin have been delivered in currently marketed ENDS
We also received comments stating designated GRAS for food does not varies widely depending on product
that the aerosol is completely harmless necessarily mean that these components characteristics, user puffing behavior
or significantly less harmful than are safe for inhalation. (See additional and nicotine solution concentration,
tobacco smoke from combusted tobacco responses in this section of the leaving smokers unaware of the nicotine
products; the comments included data document regarding FDA’s concerns levels they are receiving (Ref. 163). In
from peer-reviewed publications (Refs. with ENDS aerosol.) addition, FDA agrees that many factors
144, 156, 157, 158), a presentation at a (Comment 125) Several comments influence the delivery of nicotine. For
professional conference (Ref. 159), and that stated that e-cigarettes are harmless example, an experienced ENDS user
individual company testing. These cited one study in which the author may be exposed to amounts of nicotine
comments also submitted research that concluded that there ‘‘is no serious similar to those delivered by cigarette
was not peer-reviewed, which stated concern about the contaminants such as smoking (Ref. 114). Also, as stated
that there were no key tobacco smoke volatile organic compounds’’ in the e- earlier, nicotine-free e-liquid that is
toxicants in e-cigarettes (Ref. 160). cigarette ‘‘vapor’’ and that tobacco- intended or reasonably expected to be
(Response) FDA recognizes that the specific nitrosamine (TSNA) levels in used with or for the human
aerosol that is exhaled by users of some the ‘‘vapor’’ are just as hazardous as consumption of tobacco products in
e-cigarettes and similar electronic those TSNAs in NRT products (Ref. most cases would be a component or
apparatus may not pose as much harm 162). Some of these comments part of a tobacco product and, therefore,
as smoke emitted from combusted specifically asked why FDA did not within the scope of this rule. These
tobacco products. However, given that include this study in the proposed products will be evaluated on a case-by-
studies do indicate that both nicotine deeming rule. case basis.
and other toxicants are found in the (Response) FDA has considered these (Comment 127) Many comments
exhaled aerosol, limiting exposures findings and agrees that the exhaled discussed the possibility of nicotine
must be considered. (See section XII aerosol from ENDS users is potentially poisoning due to improper access to, or
regarding the potential for product less hazardous than secondhand smoke use of, e-liquids. Most of these
standards and tobacco product from combusted cigarettes. However, comments expressed concerns about the
manufacturing practices on FDA disagrees with the author’s growing number of calls to poison
manufacturers of newly deemed conclusion that exposure to aerosol control centers due to accidental
products.) In the absence of short- and (‘‘vapor’’) ‘‘pose[s] no apparent nicotine poisoning. Others believed this
long-term studies on the potential concern’’ (Ref. 162). FDA recognizes concern was overstated and noted that
impact of secondary exposure to that the aerosol that is exhaled by users many drugs can cause poisoning if
aerosol, FDA cannot conclude that the of some e-cigarettes and similar stored improperly. They stated that the
aerosol is harmless. Moreover, as stated electronic apparatus may not pose as addition of child-resistant containers
throughout this document, the Tobacco much harm as smoke emitted from would alleviate this concern. Some also
Control Act does not require that FDA combusted tobacco products. However, noted that e-cigarette users self-titrate
make a finding that a product is harmful given that studies do indicate that both the nicotine dosage, so concerns about
in order to deem it to be subject to nicotine and other toxicants are found overdosing should be minimal (Ref. 84).
chapter IX of the FD&C Act; FDA is in the exhaled aerosol, limiting (Response) FDA is concerned about
authorized to deem any product that exposures must be considered. FDA has the risk of nicotine poisoning in both
meets the definition of a ‘‘tobacco repeatedly noted the potential benefits users and nonusers. The CDC has
product’’ pursuant to section 901 of the and need for additional information reported more than 2,400 calls to U.S.
FD&C Act. regarding ENDS and, therefore, the poison control centers for e-liquid
(Comment 124) A few comments research included in the NPRM exposure between September 2010 and
stated that the aerosol must be safe accurately summarized the state of the February 2014 (Ref. 164). In another
because the primary constituents of the research on e-cigarettes (and the other study of 1,700 e-liquid exposures
liquid that generate the e-cigarette newly deemed products) at the time it reported to U.S. poison control centers
aerosol are propylene glycol and was drafted. from June 2010 through September
glycerin. They stated that inhalation of (Comment 126) A few comments 2013, children 5 years of age or younger
such constituents is harmless because claimed that there are many e-liquids on represented the largest proportion of
they are designated as ‘‘generally the market that do not contain nicotine e-liquid exposures and the group with
recognized as safe’’ (GRAS) by FDA. and, therefore, e-liquids should not be the greatest increase in exposures per
They cited animal inhalation studies regulated. Other comments provided month in the first three quarters of 2013
showing limited toxicological effects studies that showed that e-cigarettes (Ref. 165). Studies show that nicotine in
from either propylene glycol or glycerin deliver nicotine but noted that delivery sufficient concentrations, either when
(e.g., Ref. 161). is dependent on the e-cigarette ingested or in contact with the skin, can
(Response) FDA disagrees with apparatus and liquid type, the rate at result in serious or fatal poisoning and
comments claiming that the aerosol is which the nicotine is delivered, and the is concerning (Refs. 166, 167).
safe due to certain components being user’s experience with e-cigarette use Symptoms of toxicity include nausea,
recognized as GRAS. It is important to (Ref. 130). vomiting, seizures, coma, cardiovascular
note that the definition of food additive (Response) FDA is aware that, instability, respiratory arrest, and
in section 201(s), and its exclusion of although some ENDS and e-liquids are sometimes death. Although there was
GRAS substances, relates to intended marketed as nicotine free, as stated in disagreement among the comments as to
uses that may reasonably be expected to section VIII.D, studies have found that the level of nicotine that causes
poisoning, the nicotine content of many stated that liquid nicotine is completely maternal and fetal health during
refillable vials could be toxic to adults benign (and that FDA should not pregnancy, contributing to multiple
and children regardless of the regulate e-cigarettes given the lack of adverse outcomes such as preterm
measurement used. Accordingly, harms). They claimed that FDA’s delivery and stillbirth (id.). Further,
elsewhere in this issue of the Federal findings regarding NRTs illustrate that data suggest that nicotine exposure
Register, FDA has made available draft nicotine is not carcinogenic to humans. during adolescence may have lasting
guidance, which when final will (See ‘‘Modifications To Labeling of adverse consequences for brain
describe FDA’s current thinking Nicotine Replacement Therapy Products development (id.). Some studies also
regarding some appropriate means of for Over-the-Counter Human Use,’’ 78 have found that nicotine can have
addressing the premarket authorization FR 19718, April 2, 2013.) Other detrimental effects on the
requirements for newly deemed ENDS comments stated that although nicotine cardiovascular system and potentially
products, including recommendations has some side effects, it is significantly disrupt the central nervous system
for exposure warnings and child- less hazardous than the toxicants (Refs. 14, 15). See also section VIII.C
resistant packaging that would help ingested with combusted products. Still discussing the increase in poisoning due
support a showing that the marketing of others claimed that nicotine is very to accidental nicotine ingestion.
a product is appropriate for the dangerous. FDA is not stating that nicotine is
protection of the public health. In Comments that claimed that nicotine harmless. Unlike ENDS, which have not
addition, FDA issued an ANPRM prior is dangerous cited studies showing that been reviewed by FDA, the NRT
to this deeming rule, seeking comments, although nicotine may not be a primary products mentioned in the comments
data, research, or other information that carcinogen, it likely promotes cancers are regulated and have undergone
may inform regulatory actions FDA established through angiogenic premarket review by FDA’s Center for
might take with respect to nicotine (promoting of blood vessels in tumors) Drug Evaluation and Research (CDER)
exposure warnings and child-resistant effects (e.g., Ref. 169). The comments and been found to be safe and effective
packaging. also noted that the 2014 Surgeon before obtaining authorization to enter
(Comment 128) Some comments General’s Report stated that the health the market (sections 505 and 506 of the
compared the poison risks of nicotine risks of nicotine are more serious than FD&C Act). The Agency does not have
against other household products, previously thought and that FDA should sufficient data to be able to conclude
noting that the incidence of nicotine consider this when evaluating the that consumers are inhaling only
poisoning is significantly lower than for impacts of the newly deemed products nicotine, and no other chemicals or
other household products (Ref. 168). on vulnerable populations. Others toxicants, when using ENDS. Although
(Response) Regardless of the believed that nicotine is so dangerous ENDS likely do not deliver the same
incidence of nicotine poisoning in that individuals should be required to level of toxicants as cigarettes, studies
comparison to poisonings attributed to obtain a certification before being show that there are dangers associated
other household products, the dramatic permitted to acquire and handle it. with ENDS use and that exhaled aerosol
rise in nicotine poisoning from e-liquid (Response) In the proposed deeming is not simply ‘‘water vapor,’’ as some
exposures is very concerning. FDA is rule, FDA recognized the impact of believe. (See section VIII.C for
taking under advisement the submitted nicotine on a youth’s brain (see 79 FR additional discussion about the
data regarding nicotine poisoning and 23142 at 23153 and 23154) and also toxicants in ENDS vapor.)
suggestions for measures that FDA can noted poisoning concerns. The (Comment 130) At least one comment
take in a separate rulemaking to address inhalation of nicotine (i.e., nicotine suggested that to help address the
the issue, including establishment of without the production of combustion) dangers of nicotine and its use in future
tobacco product manufacturing practice is of less risk to a user than the tobacco products, manufacturers
regulations under section 906(e) and inhalation of nicotine delivered by registering future products with FDA
tobacco product standards under section smoke from combusted tobacco should provide documents
907 of the FD&C Act. In addition, as products. However, limited data demonstrating the accuracy of stated
stated previously, FDA issued an suggests that the pharmacokinetic nicotine levels and that the products are
ANPRM prior to this deeming rule properties of inhaled nicotine can be diacetyl and acetyl propionyl free.
seeking comments, data, research, or similar to nicotine delivered by (Response) FDA agrees with the need
other information that may inform combusted tobacco products. Thus, to carefully monitor future tobacco
regulatory actions FDA might take with inhaled nicotine from a non- products and to evaluate the
respect to nicotine exposure warnings combustible product may be as toxicological concern of chemical
and child-resistant packaging. addictive as inhaled nicotine delivered ingredients, such as diacetyl and acetyl
Moreover, elsewhere in this issue of the by combusted tobacco products. propionyl, in e-liquids and that
Federal Register, FDA has made Researchers recognize that the effects statements about the nicotine
available draft guidance, which when from nicotine exposure by inhalation concentration in the e-liquid as well as
final will describe FDA’s current are likely not responsible for the high the amount of nicotine that will be
thinking regarding some appropriate prevalence of tobacco-related death and delivered to the user are accurate. FDA’s
means of addressing the premarket disease in this country (Refs. 10, 11). review of SE reports and PMTAs under
authorization requirements for newly Although nicotine has not been shown sections 905 and 910 of the FD&C Act
deemed ENDS products, including to cause the chronic disease associated will often include analysis of the
recommendations for exposure with tobacco use, the 2014 Surgeon chemicals included in the products. In
warnings and child-resistant packaging General’s Report noted that there are addition, the requirements to submit
that would help support a showing that risks associated with nicotine (Ref. 9 at ingredient listings under section 904
the marketing of a product is 111). For example, nicotine at high and HPHC testing data under sections
appropriate for the protection of public enough doses has acute toxicity (id.). 904 and 915 are expected to alert FDA
health. Nicotine exposure during fetal to the existence of these HPHCs in e-
(Comment 129) Comments were development has lasting adverse liquids.
divided as to whether nicotine is consequences for brain development (Comment 131) Many comments
dangerous to humans. Some comments (id.). Nicotine also adversely affects expressed concerns regarding the high
cost associated with testing for HPHCs (Response) FDA understands the lethal level of nicotine being in the 10
in each individual e-liquid and e- comments’ concerns about the safety of to 60 milligram (mg) range; however,
cigarette product. They suggested that e-liquids. As stated previously, FDA other comments claimed the lethal dose
FDA use enforcement discretion, as the issued an ANPRM prior to this deeming of nicotine is actually much greater (Ref.
Agency has done previously, to reduce rule seeking comments, data, research, 172).
the regulatory burden for e-cigarette or other information that may inform Some comments expressed concern
manufacturers. For example, they noted regulatory actions FDA might take with that this rule does not address the
that FDA has compliance policies for respect to nicotine exposure warnings possibility of a dangerous
the submission of SE reports for certain and child-resistant packaging. Also, contamination of a batch of e-liquid
product modifications and HPHC elsewhere in this issue of the Federal because it does not include quality
reporting. To reduce the regulatory Register, FDA is announcing the control measures or product standards
burden, they suggested that FDA not availability of a draft guidance, which that could prevent such contamination.
require ingredient disclosure of all when finalized will provide FDA’s They believed that FDA’s authority to
unique e-liquid products under section current thinking regarding some establish tobacco product
904(a)(1) of the FD&C Act because such appropriate means of addressing the manufacturing requirements or product
a requirement is unreasonable given the premarket authorization requirements standards in the future was insufficient
many different e-liquid formulations in for newly deemed ENDS products, to address this concern.
these retail establishments. They stated including recommendations for (Response) FDA is aware of the
that in lieu of ingredient listings, FDA exposure warnings and child-resistant variability of nicotine among certain
should accept a table of all ingredients packaging that would help support a ENDS and that the labeling may not
used in e-liquids along with use-level showing that the marketing of a product accurately reflect the nicotine levels.
(concentration) ranges (i.e., minimum is appropriate for the protection of After this rule becomes effective, FDA
and maximum percentages) of those public health. FDA also intends to has the authority to issue tobacco
ingredients in their products. These consider these and other issues during product manufacturing practice
comments further suggested that FDA its premarket review of these products. regulations under section 906(e) of the
allow companies to simply amend their Further, after the effective date of this FD&C Act to address this issue. The
ingredients lists when altering products rule, FDA can exercise its authorities PMTA process (particularly, the
rather than requiring them to submit under the Tobacco Control Act to take requirement to submit information on
PMTAs. additional steps to address the safety of manufacturing methods) also provides a
(Response) Once this rule becomes e-liquids. mechanism through which products
effective, newly deemed products (Comment 133) Some comments that are more harmful or addictive than
automatically become subject to chapter included data regarding the variations products on the market at the time of
IX and all of its provisions applicable to among the nicotine levels in e-liquids, submission would be denied entrance to
tobacco products, without exception. including data showing that the nicotine the market. Moreover, immediately
Therefore, all manufacturers and levels of the products are not accurately upon the effective date of this rule, if
importers of the newly deemed products reflected in the nicotine concentration FDA determines that an e-liquid has
will be subject to the requirements stated on the labels. For example, one been contaminated and is therefore
under sections 910, 905, and 904 of the study found nicotine content labels to adulterated under section 902 or that it
FD&C Act upon the effective date of this be highly inaccurate and determined is misbranded under section 903 of the
final rule. that products claiming to be nicotine- FD&C Act because its labeling is false or
However, FDA has established a free actually contained high levels of misleading, it can initiate enforcement
compliance policy for certain nicotine (Ref. 170). Other comments action such as a seizure, injunction, or
circumstances. See section IV.D stated that the variations are no longer criminal prosecution.
describing the compliance policy as significant among the newer e- (Comment 134) A few comments
regarding certain provisions and small- cigarette products, and that newer expressed concern that FDA may limit
scale tobacco product manufacturers. studies reported more consistent the availability of e-liquids to
nicotine levels (Ref. 171). established manufacturers only and
D. Quality Control Many comments cited several studies prohibit individuals from mixing their
In the NPRM, FDA recognized of newer e-cigarettes which continued own e-liquids. These comments stated
previous instances of lack of quality to find wide variability in e-cigarette that they need access to products of
control for certain e-cigarette products engineering, including nicotine reasonable potency, high purity, and
(79 FR 23142 at 23149). FDA indicated concentrations in e-liquid, that were high quality.
that the premarket review requirements inconsistent with the information (Response) This final deeming rule
that will automatically apply to the contained on the product label (Ref. 16). places some restrictions on the sale and
newly deemed products can help to For example, one 2014 study of e-liquid distribution of tobacco products, such as
address quality control concerns. refills found that the actual nicotine minimum age restrictions, but it does
(Comment 132) Many comments level of 65 percent of the e-liquids not bar sales to individuals generally.
expressed concern regarding the lack of deviated by more than 10 percent from (Comment 135) At least one comment
controls in place for the mixing of e- the nicotine concentrations printed on noted that, although there have been
liquids. They stated that these liquids the labels (Ref. 17). Other studies found fires due to mishandling of e-cigarette
are often mixed by individual variability among nicotine batteries, cases of accidental poisoning,
consumers or employees of e-cigarette concentrations, but the nicotine levels and concerns about functionality, the
retail establishments who may lack were equivalent to or lower than ‘‘de facto regulations’’ that are in place,
training or knowledge of guidelines for advertised (Refs. 18, 19). In one study, ‘‘namely brand equity, potential civil
handling such products. Several researchers stated that the total amount liability, and word-of-mouth’’ have been
retailers of e-liquids submitted of nicotine in the e-liquid studied was effective in helping the market evolve
comments stating that they have potentially lethal if an individual were and controlling behavior.
controls in place to ensure the safety of to drink it or absorb it through the skin (Response) FDA disagrees. FDA’s
their e-liquids. (Ref. 18). They based this finding on the adverse event reporting system has
inherent limitations as a measure of the (Response) FDA agrees with materials used in the manufacture of e-
impact of e-cigarettes since ENDS are a comments’ concerns regarding quality cigarette components and packaging
newly deemed product and reporting control and the safety of ENDS that come into direct contact with e-
adverse events associated with tobacco manufactured both domestically and in liquids. They noted that improper e-
products (including e-cigarettes and other countries. One of the immediate cigarette construction and e-liquid
other ENDS) is voluntary. FDA remains benefits of deeming ENDS is that all packaging materials could also result in
concerned about adverse events newly deemed products, including hazardous leachates or degradation of
associated with ENDS use, including ENDS, that meet the definition of ‘‘new products in the e-liquid that may
overheating and exploding batteries as tobacco product’’ will be subject to the become aerosolized and inhaled upon
reported in the news, and the vast premarket authorization requirements in use.
evidence that accidental nicotine sections 905 and 910 of the FD&C Act. (Response) With this final rule, FDA
poisoning is increasing in the wake of In addition, FDA has announced its is deeming all products, except for
growing e-cigarette use. Toward that intention in the Unified Agenda to issue accessories of newly deemed products,
end, elsewhere in this issue of the a NPRM that would apply the that meet the definition of ‘‘tobacco
Federal Register, FDA has made registration and listing requirements of products’’ under section 201(rr) of the
available draft guidance, which when section 905 to foreign establishments. FD&C Act, which includes the
final will describe FDA’s current (Comment 138) Some comments components and parts (including
thinking regarding some appropriate suggested that to properly regulate e- packaging of such products). FDA will
means of addressing the premarket cigarettes, given their position on the consider the issues raised by the
authorization requirements for newly continuum of nicotine-delivering comments when it develops a NPRM on
deemed ENDS products, including products, FDA should regulate these tobacco product manufacturing
compliance with existing voluntary products based on the size of the practices.
standards for ENDS batteries. In manufacturer—which is generally
E. Misperceptions
addition, concerns remain regarding smaller than the size of companies that
manufacture cigarettes and smokeless In the NPRM, FDA noted its concerns
quality control, which could impact the
tobacco products. They also suggested regarding consumer misperceptions of
functionality of these products. FDA
that FDA stagger the compliance periods currently unregulated products,
believes that the automatic statutory
for submission of PMTAs so that smaller particularly e-cigarettes. Many
provisions that will apply to these
companies have additional time to comments provided data to substantiate
products as a result of this deeming
prepare their submissions. those concerns and others provided data
rule, in conjunction with additional
(Response) Section IV.D has and personal stories regarding the
authorities under the law that FDA can potential benefits of e-cigarettes. Other
additional information about
exercise after the effective date, will comments indicated that, based on these
compliance periods for small-scale
help address these concerns. potential benefits, they believed e-
tobacco product manufacturers. FDA’s
(Comment 136) At least one comment compliance policy for the submission of cigarettes to be safe tobacco products.
sought clarification as to why FDA SE reports, SE exemption requests, and (Comment 141) Many comments
expressed concern about quality control PMTAs for all manufacturers of deemed stated, but did not provide supporting
issues for e-cigarette products but not products is included in section IV.C. data, that e-cigarettes: (1) Are
for combusted products that contain (Comment 139) One comment approximately 99 percent less
thousands of toxic constituents. recommended that FDA collaborate hazardous than cigarettes; (2) are only
(Response) FDA is concerned about with other Federal Agencies, including consumed by smokers and former
quality control for all tobacco products the National Institutes of Health (NIH), smokers who quit by switching to e-
and will continue to monitor these CDC, and the Substance Abuse and cigarettes; and (3) have not been found
products to determine if there are Mental Health Services Administration to create nicotine dependence in any
quality control issues. FDA’s premarket (SAMHSA), as well as international nonsmoker. They also stated that there
review of the newly deemed products agencies including the EU, to continue is no evidence that ingesting e-liquid
will increase product consistency. For research on tobacco products and leads to fatalities.
example, FDA’s oversight of the increase surveillance and other (Response) As discussed throughout
constituents of e-cigarette cartridges enforcement of quality control and other this document, FDA agrees that use of
would help to ensure quality control issues. ENDS is likely less hazardous for an
related to the chemicals and their (Response) FDA agrees. FDA intends individual user than continued smoking
quantities being aerosolized and to continue to review available studies of traditional cigarettes. One self-
inhaled. Quality control issues will also and fund studies on tobacco products, selected comparison reported that
be addressed in a tobacco product including studies on ENDS initiation, across several Japanese brands, under
manufacturing practices regulation that use (including transitions to other some use conditions, ENDS released 1/
FDA intends to issue at a later date. tobacco products and multiple use), 50th of the level of formaldehyde
Also, FDA may take enforcement action perceptions, dependence, and toxicity released by cigarettes (Ref. 135). The
if an ENDS or any other tobacco product (Ref. 173). FDA also has been highest level detected was six times
is adulterated or misbranded within the conducting a series of public workshops lower than the level in cigarette smoke
meaning of the FD&C Act. to obtain additional information on e- (id.). But other research, published as a
(Comment 137) A few comments cigarettes and their impact on public letter to the editor of the New England
expressed concerns regarding the health (79 FR 55815). These workshops Journal of Medicine, reported that ENDS
quality of e-cigarettes manufactured will help to inform FDA’s development operated at 5 volts delivered a mean of
overseas. They stressed the importance of future rules and policies that have an 390+/¥90 mg per 10 puff sample which
of issuing regulations to require the impact on ENDS. Additional regulations is greater than 150 mg, the estimated
registration of foreign establishments so regarding ENDS will be subject to the average delivery of formaldehyde than
that FDA knows the identity of foreign requirements of the APA. conventional cigarettes (Ref. 128). No
manufacturers and the products they (Comment 140) Some comments formaldehyde-releasing agents were
import into the United States. stated that FDA should regulate detected when ENDS were operated at
3.3 volts (Ref. 128). A subsequent peer- affirmatively disregard available safety (Response) FDA is concerned that the
reviewed article on 5 variable-power information. growth in ENDS use, particularly among
ENDS devices found large variations in (Response) As FDA stated in its youth and young adults, could lead to
formaldehyde delivery across devices proposal, many people may believe that the re-normalization of cigarette
(Ref. 129). The first device yielded more certain tobacco products covered by this smoking. The Surgeon General
formaldehyde than combustible rule present fewer health risks when recognized that adolescents are
cigarettes at every power level tested, compared to that of cigarettes (79 FR particularly vulnerable to visual cues to
and the second device delivered more 23142 at 23158 and 23159), which is smoke and to social norms, making this
formaldehyde at the highest power level supported by some of the emerging an even greater concern (Ref. 49). FDA
tested; the remaining three devices scientific literature demonstrating that believes that subjecting ENDS to its
delivered less formaldehyde than some ENDS products, operated at some tobacco control authorities, and
combustible cigarettes at all power power levels, may have lower delivery requiring compliance with the various
levels tested (id.) The same research of harmful constituents and toxicants statutory and regulatory requirements
found that aldehyde delivery varied by than that of combusted cigarettes (see (e.g., ingredient listing and others), will
750-fold from one ENDS device to discussion on the health harms of ENDS help to address the common
another (id.). The article referenced in in response to Comment 117). In fact, a misunderstanding that these products
one comment (Ref. 67) reported that recent telephone survey of 1,014 adults are safe to use.
increasing the voltage from 3.2 to 4.8 indicates that a majority of American F. Use as a Cessation Product
volts increased formaldehyde, adults surveyed (nearly two-thirds, 65
acetaldehyde, and acetone levels from 4 percent) believe e-cigarettes are harmful In the preamble to the NPRM, FDA
to over 200-fold. to the health of the people who use recognized that some consumers may
Nevertheless, as discussed in section them and 23 percent believe that they use ENDS in tobacco cessation attempts.
VIII.F, evidence shows that while most are not harmful (Ref. 176). In addition, We note that if an ENDS product seeks
ENDS are consumed by smokers and to be marketed as a cessation product,
44 percent believe that electronic
former smokers (e.g., Refs. 109, 110), the manufacturer must file an
cigarettes are less harmful than
some consumers (including youth and application with FDA’s Center for Drug
combusted cigarettes while 32 percent
young adults) are initiating tobacco use Evaluation and Research (CDER) and no
thought they were equally harmful (id.).
with ENDS. Several studies have found ENDS have been approved by FDA as
Of particular note, the survey found that
that ENDS users, particularly effective cessation aids.
‘‘[t]hose who have ever used e-cigarettes Recently published population-wide
experienced ENDS users, are able to are significantly less likely than never-
achieve nicotine exposures similar to data from the CDC’s NCHS, which
users to believe that e-cigarettes and provides the first estimates of e-cigarette
cigarette smokers (Refs. 114, 148, 149, marijuana are harmful to the health of
150). Although no studies have been use among U.S. adults from a nationally
people who use them, and more likely representative household interview
done to-date assessing the development to believe in the benefits of e-cigarettes
of dependence among non-smokers, study, indicates that current cigarette
when it comes to smoking cessation’’ smokers and recent former smokers (i.e.,
several studies have found that ENDS
(id.). those individuals who quit smoking
users, particularly experienced ENDS
Although FDA expects that youth within the past year) were more likely
users, are able to achieve nicotine
understanding and appreciation of the to use e-cigarettes than long-term former
exposures similar to cigarette smokers
and that nicotine is a known addictive health effects and risks of certain newly smokers (i.e., those individuals who
substance. Fourth, as discussed in deemed tobacco products will be quit smoking more than one year ago)
section VIII.D, the incidence of nicotine improved if they are also FDA- and adults who had never smoked (Ref.
poisoning has been on the rise and has regulated, that is only one of the many 24). Among current cigarette smokers
resulted in severe poisonings and public health benefits that will accrue who had tried to quit smoking in the
hospitalization (Ref. 174). In December from deeming them subject to the FD&C past year, more than one-half had ever
2014, after the close of the comment Act, as discussed in the NPRM (79 FR tried an e-cigarette and 20.3 percent
period for the NPRM, media reported 23142 at 23148 and 23149). were current e-cigarette users (id.).
the first death of a toddler from (Comment 143) Some comments (Comment 144) Comments were
accidental poisoning from e-liquid (Ref. expressed concern that the increase in e- divided regarding the viability of e-
175). Regulation of ENDS will help to cigarette use in places where cigarette cigarettes as a smoking cessation
alleviate consumer misperceptions such smoking is not currently allowed creates product. Some comments contended
as those expressed in the comments. confusion, particularly among children, that the actual patterns of e-cigarette
(Comment 142) Many comments who often cannot tell the difference use, citing a meta-analysis showing the
stated that e-cigarettes should be between smoking and e-cigarette use. rapid penetration of the youth market
regulated given their appeal to youth They referred to unpublished research and high levels of dual use among both
and young adults and the belief that e- and anecdotal evidence indicating that adults and adolescents, will lead to a
cigarettes are less harmful than when children see pictures of people lower probability that smokers using e-
conventional cigarettes. They agreed using e-cigarettes they report that cigarettes will quit smoking cigarettes
with FDA’s concern that a failure to someone is smoking. (Ref. 16). They also cited another study
regulate the newly deemed products Other comments disagreed, stating in which, although 85 percent of e-
could reinforce consumers’ existing that e-cigarette use will more likely lead cigarette users reported that they were
confusion and misinformation about to normalization of e-cigarettes rather using e-cigarettes to quit smoking, they
these products. However, other than cigarettes (Ref. 110). They stated were no more likely to have quit
comments stated that FDA’s concerns that one study found that daily smokers smoking than nonusers of e-cigarette
about youth’s misperception of the (aged 18 to 35 years) who observed (Ref. 178).
safety of e-cigarettes should not be a individuals using e-cigarettes only However, consumers and
factor in FDA’s decision to regulate increased the smoker’s desire for an e- manufacturers of e-cigarettes provided
them. They stated that regulation cannot cigarette, and not for a conventional information showing positive impacts of
remedy the fact that many youth cigarette (Ref. 177). e-cigarettes on cessation, including
personal anecdotes from former smokers indicate that there is currently of designs as well as variable exposures
(Ref. 132). For example, they cited a 1- insufficient data to draw a conclusion and outcome definitions (id.). While
year multinational study where about the efficacy of e-cigarettes as a some potential confounders were
researchers found that among smokers cessation device (Refs. 185, 186). The controlled for in most of the studies, the
who were using e-cigarettes at the Cochrane Collaboration’s systematic investigators acknowledged that there
baseline, 22 percent had quit smoking review and meta-analysis assessed may be other unidentified confounders
after 1 month and 46 percent had quit approximately 600 scientific records to that could be a source of bias. This
smoking after 1 year (Ref. 179). In a include two randomized controlled potential bias as well as other
survey of adults in the United Kingdom trials and 11 cohort studies on e- limitations described may impact
who tried to quit smoking at least once cigarettes and smoking cessation in their interpretability of the overall findings
in the past year, respondents who used review (Ref. 186). As the Cochrane (id.).
e-cigarettes had a higher quit rate (20 review judged RCTs to be at low risk of We also note that ENDS have not been
percent) than those who used NRTs like bias, the investigators combined results approved as effective cessation aids.
patches or gum (10 percent) or those from two randomized controlled trials, FDA remains committed to supporting
that did not use a cessation aid (15 totaling over 600 people, and conducted long-term population-level research that
percent) (Ref. 180). These comments a quantitative meta-analysis. Results will help fill in current data gaps.
also asserted evidence that e-cigarette indicated that using e-cigarettes with (Comment 145) At least one comment
use, at a minimum, leads to decreased nicotine was associated with increased suggested that FDA provide physicians
cigarette use (e.g., Refs. 107, 181). One smoking cessation as compared with e- with guidelines about e-cigarette use,
comment also noted that tribes use e- cigarettes without nicotine. Investigators including its health impact and efficacy
cigarettes as an alternative to smoking also found evidence that using e- as a cessation tool.
and to promote cessation. cigarettes with nicotine also helped (Response) To the extent the comment
more smokers reduce the amount they is about ENDS products that are drugs
(Response) As we have stated because they are marketed for cessation,
throughout this document, we recognize smoked by at least half compared to e-
an ENDS product marketed for
that there is emerging data that some cigarettes without nicotine. However,
therapeutic purposes is a drug or device
individual smokers may potentially use the authors cautioned that ‘‘the small
subject to FDA’s regulations and laws
ENDS to transition away from number of trials, low event rates and
for those products.
combustible tobacco products. For wide confidence intervals around the (Comment 146) A few comments
instance, prospective studies of varying estimates mean that our confidence in expressed concern that FDA
duration examining the efficacy of e- the result is rated ‘low’.’’ (Ref. 186) In misrepresented certain studies in the
cigarettes as cessation devices suggest addition, the authors observed that ‘‘the NPRM and would not consider research
their potential to decrease combustible overall quality of the evidence for our released since the issuance of the
cigarette use as well as promote outcomes was rated ‘low’ or ‘very low’ NPRM, particularly regarding the
abstinence from combustible cigarettes because of imprecision due to the small effectiveness of e-cigarettes as a
(Refs. 107, 149, 182, 183, 184). Three number of trials’’ (id.). Another meta- cessation tool.
randomized controlled clinical trials analysis of the same two trials of e- (Response) FDA has considered the
(Ref. 107, 149, 184) report that e- cigarettes with and without nicotine preliminary evidence regarding the
cigarettes may help some smokers to found comparable results (Ref. 187). The effectiveness of ENDS to help smokers
stop smoking. The trial that compared e- authors also reported a pooled estimate quit or to reduce their consumption of
cigarettes to nicotine replacement of cessation among nicotine e-cigarette combusted tobacco products. There is
therapy found verified abstinence in all users, but the lack of non-e-cigarette some indication that such products may
experimental groups, but no significant control groups in the studies prevented have the potential to help some
difference among e-cigarettes, placebo e- them from comparing the efficacy of e- individual users to quit using
cigarettes (i.e., e-cigarettes with no cigarettes against no e-cigarette use and combusted tobacco products or to
nicotine), and nicotine patches in six- against standard interventions for reduce their use of such products, as
month abstinence rates (Ref. 184). cessation, such as nicotine patches (id.). reported by scientific literature
Achievement of abstinence was An alternate systematic review and describing a small number of
substantially lower than the optimistic meta-analysis of approximately 600 randomized controlled trials evaluating
estimates on which the power scientific records to include 15 cohort the impact of ENDS use on smoking
calculation and study sample size were studies, 3 cross-sectional studies, and outcomes (Refs. 137, 148, 184) and pilot
based, and thus, the researchers could two clinical trials (one RCT, one non- studies evaluating ENDS use on
conclude no more than that ‘‘among RCT) examined the association between smoking reduction and cessation (Refs.
smokers wanting to quit, nicotine e- e-cigarette use and cessation in 182, 183). But other evidence is to the
cigarettes might be as effective as observational epidemiological studies contrary. Beyond the meta-analysis
patches for achieving cessation at 6 and clinical trials; all 20 studies discussed in section V(B)(3), a year-long
months’’ (id.). It is possible that longer compared smoking cessation rates for e- study of over 5,000 20-year-old Swiss
term prospective studies may—or may cigarette users against control groups of men found that, even after adjusting for
not—demonstrate statistically smokers who did not use e-cigarettes nicotine dependence, individuals who
significant cessation outcomes for e- (Ref. 112). This meta-analysis found were smokers at the start of the study
cigarettes in relation to conventional overall that odds of quitting cigarettes and who reported e-cigarette use at the
nicotine replacement therapies (id). It is were on average 28 percent lower for end of the study were more likely to still
noteworthy that a third of the smokers who used e-cigarettes than be smoking and more likely to have
participants allocated to the e-cigarettes those who did not (odds ratio = 0.72, made one or more unsuccessful quit
groups in this study reported continued with 95 percent confidence interval 0.57 attempts at the end of the year than
product use at 6 months, suggesting that to 0.91) (Ref. 112). Of note, this meta- individuals who were smokers at the
they might have become long-term e- analysis included chiefly observational start and who reported no e-cigarette
cigarette users (id.). However, some studies whose control groups were not use (Ref. 188). The most important
systematic reviews of available evidence randomized, and included a wide range consideration is that ENDS are not an
FDA-approved cessation product. If an premarket applications containing data continuum of nicotine delivering
ENDS manufacturer wishes to make a and information establishing safety and products. For example, they suggested
cessation claim or otherwise market its effectiveness. No ENDS has yet been that FDA differentiate between
product for therapeutic purposes, the approved by CDER. substances that contain tobacco and
company must submit an application for (Comment 149) Comments in support those that are derived from tobacco and
their ENDS to be marketed as a medical of limited or no regulation of e- provide a separate regulatory approach
product. cigarettes stated that these products for each product category.
(Comment 147) Some comments have a positive impact on the public Some comments also suggested that
expressed concern that e-cigarette users health at the population level. They FDA tailor its regulatory approach based
are developing an addiction to nicotine cited online surveys and convenience on the type of electronic apparatus—
while seeking to overcome their store data showing that most e-cigarette e.g., advanced refillable personal
smoking addiction and that the lack of users do not use additional tobacco vaporizers (ARPVs) or open-system
regulation makes it difficult for users to products (see section VIII.H) and vapor products versus ‘‘cigalike’’
know the nicotine level that they need claimed that FDA cherry-picked the products (ready for use products that
in their e-cigarettes to overcome their evidence regarding dual use in the look like cigarettes and are sold in
addiction. They stated that for cigarette NPRM. They also claimed FDA did not convenience stores). These comments
smokers who are trying to replace their adequately assess the reduction in believed FDA should only deem
cigarette-derived nicotine with e- smoking that would result from ‘‘cigalike’’ products that are ready for
cigarettes, ingredient listing and other increased e-cigarette use and, as a result, consumption, because they are easily
requirements are vital to ensure that the Agency underestimated the accessible to youth and have been
users know how much nicotine they are potential positive impacts of e-cigarettes associated with quality control issues
ingesting. on the public health at the population (see section VIII.D). They noted that
(Response) By deeming ENDS, FDA level. ARPVs and other open systems are
has ensured that these products are now (Response) Many provisions of the significantly more expensive than
subject to requirements related to FD&C Act call for a population-level ‘‘cigalike’’ products and are only offered
ingredient and HPHC reporting, among public health analysis that takes into in vape or specialty shops. They
other requirements. In addition, the account the population as a whole, compared this to Option 1 (to deem all
registration and listing requirements including users and nonusers of tobacco cigars) and Option 2 (to deem all cigars
and premarket applications will provide products (e.g., section 906(d) of the except premium cigars) and suggested
FDA with vital information as to the FD&C Act). Even products that are less that FDA should have provided similar
extent of ENDS use and how many toxic than combusted tobacco products options for regulating different e-
ENDS products consumers are using on on an individual user basis may cigarettes. They also expressed the need
a daily basis. increase public health harms if, for for a different regulatory approach for
(Comment 148) Some comments example, they encourage nonusers to ARPVs because they provide users with
perceived the newer generation of e- start using tobacco products that can the best opportunity to cease using
cigarettes to be less addictive than lead to lifelong nicotine addiction. combusted tobacco products (Ref. 190).
combusted cigarettes and closer in As we have stated throughout the However, other comments provided
profile (including risk profile) to NRTs document, FDA has examined data focus group research in which smokers
(Ref. 76). They noted the limited regarding health harms generally rated cigalikes to be significantly more
number of significant adverse events associated with all of the categories of satisfying than ARPVs and asked for a
resulting from e-cigarette use and tobacco products regulated under this minimal regulatory approach for
claimed that such adverse events are not rule (including ENDS, which FDA cigalikes.
distinguishable from NRTs (Ref. 184). recognizes may potentially provide Further, some comments stated that it
Some comments also believed that FDA cessation benefits to some individual was not feasible to regulate ARPVs.
should consider the advantages that e- smokers). FDA is regulating these They stated that the wide varieties of e-
cigarettes have (as compared to NRTs) products in accordance with this liquids available at e-cigarette retail
when establishing the regulatory knowledge and will continue to regulate establishments and the ability of users
approach for these products, including as we learn more about the potential for to customize their experience, including
the fact that they offer appealing visual, product-specific health harms. FDA by altering the product’s voltage/
tactile, and gestural similarities to recognizes that some ENDS users report wattage, puff duration, coil resistance,
cigarettes, and that e-cigarettes provide that the products have the potential to cartridge/battery duration, and design
quicker nicotine delivery than NRTs help individual users to quit smoking. aesthetics, make oversight, application
(Ref. 189). However, FDA’s responsibility is to review, and other regulation untenable.
(Response) As we have stated assess the population health impact of Other comments stated that, instead
throughout this document, we recognize ENDS, including increasing youth use, of establishing a different regulatory
that individual smokers may report as well as the frequency of dual use of approach, FDA should ban ARPVs
cessation benefits from ENDS and that ENDS and combusted tobacco products. because there is greater risk associated
preliminary research outcomes from FDA believes that data from long-term with their use and children may tamper
randomized controlled trials indicate population level studies, such as the with them. They suggested that if FDA
that ENDS may decrease some PATH Study, will help to provide does not ban these products, FDA
individuals’ cigarette consumption and information about the overall should require the disclosure of all
promote cessation. However, the risk population health impacts of ENDS. ingredients in e-liquids and other
profile is likely to be different as (Comment 150) Many comments vaporized nicotine products in both
compared to NRTs, and the long-term provided personal stories and peer- their pre-use and vapor states.
risks associated with chronic use of reviewed studies to illustrate the (Response) To the extent that
ENDS are unknown. Finally, contrary to benefits of e-cigarettes as a cessation comments are asserting that FDA should
ENDS, the nicotine patch and other product and to request that FDA treat not regulate ENDS or subject them to
NRTs were found to be safe and this product category differently based certain provisions, FDA disagrees with
effective by FDA’s CDER after reviewing on where the product falls within the these comments, especially given that
ENDS use among youth and young regarding some appropriate means of unsubstantiated claims, as many had
adults is increasing. Although recent addressing the premarket authorization done with respect to their designation of
data on young adults and adults requirements for newly deemed ENDS cigarettes as ‘‘light,’’ ‘‘low,’’ or ‘‘mild.’’
indicate that ENDS users are more likely products, including recommendations The mistaken belief that ‘‘light’’ and
to be former cigarette smokers and for nicotine exposure warnings and ‘‘low-tar’’ cigarettes were safer than
current cigarette smokers who have child-resistant packaging that would other cigarettes prompted many smokers
tried to quit (e.g., Ref. 24), there is still help to support a showing that the to switch to such products instead of
some use among adult non-tobacco marketing of a product is appropriate for quitting altogether. Section 911 will
users, particularly among young adults. the protection of the public health. prevent consumers from being similarly
In addition, the rapid increase in use (Comment 152) Some comments misled by ensuring a manufacturer may
among adolescents is concerning. FDA stated that e-cigarettes should be subject not make unsubstantiated claims.
also remains concerned that ARPVs to little or no FDA regulation, because Manufacturers that have data to
present the risk of accidental nicotine e-cigarettes inhibit withdrawal substantiate modified risk claims for a
poisoning. In addition, researchers symptoms in users with a history of particular product can submit an MRTP
recently reported that the new relapse (Ref. 191) and lead to reduction application so that FDA can determine
generation of high voltage ENDS may and cessation in asthmatic smokers (Ref. that the product meets the statutory
put users at increased risk of negative 107). standard and can issue an order
health effects (Ref. 67) and that ARPVs (Response) FDA disagrees. Although authorizing it to be marketed as an
have the potential for increased abuse ENDS may potentially provide cessation MRTP.
liability (e.g., Refs. 109, 132, 171). FDA benefits to individual smokers, no ENDS As Congress recognized,
will continue to monitor research have been approved as effective
cessation aids. If an ENDS manufacturer [u]nless tobacco products that purport to
regarding the health effects of different reduce the risks to the public of tobacco use
types of ENDS and may tailor the wishes to make a cessation claim, the
actually reduce such risks, those products
regulatory requirements accordingly. company must submit an application for can cause substantial harm to the public
(Comment 151) Some comments their ENDS to be marketed as a medical health to the extent that the individuals, who
requested that FDA either exempt e- product. would otherwise not consume tobacco
cigarette products from the deeming G. Modified Risk Claims products or would consume such products
regulation or strike the entire proposal less, use tobacco products purporting to
for e-cigarettes and replace it with what In the NPRM, FDA noted that it reduce risk. Those who use products sold or
they considered a more science-based expects public health benefits through distributed as modified risk products that do
approach or with rules that address the application of section 911 of the not in fact reduce risk, rather than quitting
FD&C Act to the newly deemed tobacco or reducing their use of tobacco products,
good manufacturing practices and
products. Historically, certain users have a substantially increased likelihood of
consumer safety, given their potential suffering disability and premature death. The
for use as cessation products. have initiated and continued using
costs to society of the widespread use of
(Response) FDA disagrees. This final certain tobacco products based on products sold or distributed as modified risk
deeming rule is a foundational rule that unauthorized modified risk claims and products that do not in fact reduce risk or
will provide many public health consumers’ unsubstantiated beliefs. that increase risk include thousands of
benefits, as described in the NPRM (79 Application of section 911 will prohibit unnecessary deaths and injuries and huge
FR 23142 at 23148 and 23149), and will the introduction into interstate costs to our health care system.
provide FDA with critical information commerce of MRTPs unless FDA issues (section 2(37) of the Tobacco Control
about the health risks of ENDS and an order permitting their marketing. Act).
other newly deemed products, (Comment 153) A few comments
including data from ingredient listing expressed concern that imposition of (Comment 154) Some comments
submissions and reporting of HPHCs section 911 of the FD&C Act will force believed that e-cigarettes should only be
required under the FD&C Act. Also, e-cigarette manufacturers to implicitly authorized as MRTPs, rather than new
once this rule becomes effective, newly lie by not permitting them to tell tobacco products via the PMTA or SE
deemed products may be subject to consumers that their products are safer pathways, because that would allow
additional regulations. For example, alternatives to conventional cigarettes, them to meet the predominant
FDA has the authority under section to advertise that they do not contain expectations of consumers.
906(e) of the FD&C Act to issue a rule tobacco, and to state that they are (Response) FDA disagrees. The
establishing tobacco product ‘‘smoke free.’’ They added that the Tobacco Control Act requires all new
manufacturing practices, and this public already overwhelmingly believes tobacco products, including MRTPs, to
authority applies to deemed products. that e-cigarettes are reduced risk go through premarket review and obtain
FDA also has the authority under products and, therefore, the section 911 a marketing authorization order via the
section 907 of the FD&C Act to establish requirements are irrelevant (Refs. 178, PMTA, SE., or SE exemption pathways.
product standards for deemed products, 192). However, other comments stated A manufacturer who wants to sell a
including requirements with respect to that manufacturers should be prohibited product for use to reduce harm or risk
packaging. The Agency issued an from making cessation claims without of tobacco-related disease can also
ANPRM prior to this deeming rule, providing scientific evidence to support obtain authorization to market an MRTP
seeking comments, data, research, or their efficacy as a cessation mechanism. if the manufacturer submits an
other information that may inform (Response) FDA disagrees with application under section 911 of the
regulatory actions FDA might take with concerns that ENDS manufacturers will FD&C Act and FDA issues such an
respect to nicotine exposure warnings not be able to make claims that properly order.
and the use of child-resistant packaging. represent their products. Section 911 is (Comment 155) A comment suggested
In addition, elsewhere in this issue of one of the provisions of the statute that that to address unauthorized modified
the Federal Register, FDA has made applies automatically to deemed risk claims, we add the following
available a draft guidance for public products. It was included in the FD&C language to the final rule: No vapor
comment, which when final will Act to protect consumers from product or alternative nicotine product
describe FDA’s current thinking manufacturers making invalid or shall be considered to be ‘‘sold or
distributed for use to reduce harm or the recently in Cancer Prevention Research, nicotine addiction and cessation. FDA
risk of tobacco-related disease investigators evaluated users of a single also is concerned because this dual and
associated with commercially marketed brand of ‘‘cig-a-like’’ ENDS and found polytobacco use pattern appears to be
tobacco products’’ solely because its that both cigarette smokers who common among adolescents and young
label, labeling, or advertising uses the switched to using the evaluated ENDS adults (Ref. 197). However, recent CDC
following phrases to describe such products and those who switched to NCHS data on young adult and adult
product and its use: ‘‘not consumed by dual use of the evaluated ENDS and use patterns of e-cigarettes indicate that
smoking,’’ ‘‘does not produce smoke,’’ cigarettes all demonstrated significant former smokers and current smokers
‘‘smokefree,’’ ‘‘without smoke,’’ ‘‘no reductions in exposure to carbon trying to quit are more likely to use e-
smoke,’’ or ‘‘not smoke.’’ monoxide and the toxicant acrolein cigarettes than former smokers who quit
(Response) Section 911 of the FD&C (Ref. 194). smoking more than 1 year ago and those
Act requires FDA to assess MRTP claims (Comment 157) Many comments who had never smoked (Ref. 24). These
for specific products. Therefore, FDA expressed concern that the rate of dual results indicate that dual use of tobacco
will evaluate products on a case-by-case use of e-cigarettes and combusted may also be present during the
basis to determine whether they are tobacco products is high, particularly transitional phase when smokers of
‘‘sold or distributed for use to reduce among middle and high school students combusted tobacco products are
harm or the risk of tobacco-related (Ref. 16). They stated that adolescents attempting to quit, which is also
disease associated with commercially do not use e-cigarettes as cessation aids supported by personal stories included
marketed tobacco product’’ as stated in but rather use them in conjunction with in the comments. In addition, the largest
section 911. However, we note that e- conventional cigarettes (Ref. 193; see study to date in the EU found that e-
cigarettes and similar ENDS products Ref. 194). They also indicated that this cigarette use was more likely among
are not ‘‘smokeless’’ products, as the dual use and the fact that youth who smokers who had made a quit attempt
user is inhaling constituents (which are experiment with e-cigarettes are 7.7 during the past year as compared to
different from a smokeless tobacco times more likely to become established those who never smoked (Ref. 109).
product, as defined in the Tobacco smokers than those who do not Other studies illustrate that current or
Control Act). In addition, FDA is aware experiment (Ref. 116) suggest that e- former smokers have tried e-cigarettes
that some ENDS might heat their cigarette use leads to increased use of not intending to quit tobacco use, but
product to a level high enough to cause combusted tobacco products. However, instead, because they are ‘‘Easy to use
combustion. they noted that we need long-term when I can’t smoke’’ (Ref. 198) or can
(Comment 156) Many comments studies like FDA’s PATH Study to be used in places where conventional
stated that the NPRM may promote confirm that assertion. Some comments tobacco use is not allowed (Ref. 199).
conventional tobacco use because e- also stated that cigarette smokers who FDA remains committed to supporting
cigarette manufacturers will be unable use a second tobacco product even long-term population-level research,
to inform smokers that their products occasionally are at higher risk for such as the PATH Study, that will help
are safer alternatives or that they do not continued tobacco use (Ref. 195). elucidate reasons for and patterns in
contain tobacco. They believed the Other comments believed that dual tobacco initiation, product switching,
NPRM weakens the impact that the e- use should not be a concern, generally and dual use across the spectrum of
cigarette industry might otherwise exert relying upon an Internet study of more tobacco products on the U.S. market,
on the tobacco industry. than 19,000 e-cigarette users in which including ENDS and conventional
(Response) FDA disagrees. First, this dual users had decreased from 20 to 4 cigarettes.
final rule does not prohibit ENDS cigarettes per day by the end of the (Comment 158) Many comments
manufacturers from making claims that study (Ref. 109). Some comments also noted that almost all e-cigarettes contain
they are safer than conventional tobacco expressed the belief that, because nicotine (Ref. 192). This nicotine
products if they can provide evidence to clinical studies show that e-cigarettes delivery varies within and across brands
satisfy the requirements and obtain deliver only modest concentrations of (Refs. 200, 201) and by the user’s level
marketing authorization from FDA nicotine to novice e-cigarettes users of experience with these products (e.g.,
under section 911 of the FD&C Act. (Ref. 196), this would also be the case Ref. 202). While many comments
Second, FDA believes that ENDS could for nonsmoking youth and young adults expressed minimal concerns about
serve as alternatives to combusted and, therefore, would make the abuse liability of e-cigarettes, believing
tobacco products. possibility of addiction less likely. that users will eventually switch
Others argued that advanced e-cigarette entirely to e-cigarettes, others expressed
H. Dual and Polytobacco Use products deliver nicotine more the belief that long-term use of e-
In the NPRM, FDA noted its concerns effectively, making adult consumers less cigarettes may lead to addiction in
that adult consumers may use one or likely to dual use or revert back to youth and young adults.
more of the proposed deemed products smoking. In addition, they claimed that (Response) FDA shares similar
in conjunction with cigarettes or other if e-cigarettes were acting as a gateway concerns that youth may initiate tobacco
tobacco products. FDA also noted that to cigarette use, the current increase in use with ENDS, become addicted, and
studies suggest that some noncigarette e-cigarette use would lead to a then dual use or move on to traditional
tobacco users may go on to become corresponding increase in youth tobacco products. FDA discussed
addicted cigarette smokers (79 FR 23142 cigarette use (which has not occurred). available data regarding dual and
at 23159). In fact, they said an overlap of polytobacco use in the NPRM and is
It is also recognized that some dual combusted tobacco and e-cigarette use is unaware of long-term studies finding
users of ENDS and cigarettes may be necessary if a tobacco user begins e- that dual or polytobacco users
transitioning away from combustible cigarette use to transition away from eventually switch to using just one
tobacco use and that such transient combusted tobacco consumption. tobacco product (79 FR 23142 at 23159
periods of dual use may not present (Response) FDA is aware of dual use and 23160). However, findings from a
greater health risks than that observed of ENDS and combusted tobacco recent study of 694 participants aged 16
during sole use of combustible tobacco. products and is concerned about the to 26 years old suggest that youth e-
In a peer-reviewed study published potential impact of this practice on cigarette users might transition to
smoking traditional cigarettes (Ref. 203). (including ENDS and other products (Response) FDA continues to research
Therefore, FDA remains concerned that that meet the statutory definition of and fund studies regarding ENDS
youth may use one of the newly deemed ‘‘tobacco product’’). All tobacco initiation, use (including transitions to
products, whether it be an ENDS or any products, regardless of the category of other tobacco products and multiple
other tobacco product, and dual use products, pose a health risk. Further, at use), perceptions, dependence, and
with other tobacco products in the this time, only some of the restrictions toxicity (Ref. 195). FDA also has been
future. in part 1140 (which, prior to the rule, conducting a series of public workshops
(Comment 159) Some comments applied only to cigarettes and smokeless to obtain additional information on e-
urged FDA to evaluate e-cigarettes based tobacco) will apply to the newly cigarettes and their impact on public
on their scientific merit and deemed products. Specifically, while health (79 FR 55815). These workshops
contribution to public health. At least the minimum age and identification, are not necessary to inform this deeming
one comment felt that certain vending machine, and free sample rule; however, they may inform FDA’s
researchers in the tobacco field were provisions will apply to the newly development of future rules impacting
biased based on their connections to deemed products, additional provisions ENDS. Any additional regulations
public health advocates or what the in part 1140 (including minimum pack regarding ENDS will be subject to the
comment refers to as ‘‘big tobacco size and restrictions on self-service requirements of the APA.
companies.’’ Some comments stated that displays, sale and distribution of (Comment 164) Some comments
FDA only considered journal articles nontobacco items, and sponsorship of sought clarification as to FDA’s
when it should have considered other events) will not apply to the newly authority over e-liquids that do not
available information. deemed products at this time. contain nicotine or other chemicals
(Response) FDA uses the best (Comment 161) Many comments derived from tobacco plants and those e-
evidence available from peer reviewed expressed concern that Congress did not liquids that contain nicotine derived
journals and other reputable sources to wish to effectively ban e-cigarettes (as from a nontobacco source (e.g.,
support this rule and fulfill our public they claimed would occur as a result of eggplants or tomatoes). Others claimed
health mandate. In the context of deeming these products), because such that FDA does not have regulatory
rulemaking, FDA follows the a ban violates section 907(d)(3) of the authority over e-cigarettes that are
requirements of Executive Orders 12866 FD&C Act. They stated that if Congress refillable and do not contain nicotine,
and 13563 by basing its decisions ‘‘on wanted to ban them, they would have but does have authority over e-liquids if
the best reasonably obtainable scientific, the liquid contains nicotine. Yet, some
done so under their drug authority.
technical, economic and other said that e-liquids used in e-cigarettes
(Response) FDA is not banning any
information.’’ As stated in the NPRM, should have an entirely new
category of tobacco product by issuing
we will continue to fund research to classification, because use of the words
this final deeming rule.
help us determine the public health ‘‘tobacco product’’ in marketing
impacts of ENDS. Long-term studies are (Comment 162) Many comments
materials would cause undue confusion
not available to conclude that ENDS are claimed that Congress did not intend for
for consumers.
a proven cessation product or to FDA to strictly apply the Tobacco (Response) As stated in section 201(rr)
establish what effect e-cigarettes have Control Act requirements to all newly of the FD&C Act, the definition of
on users who might otherwise quit but deemed products, especially those that ‘‘tobacco product’’ includes any product
instead engage in dual use of ENDS and do not contain tobacco leaf. They made or derived from tobacco,
other tobacco products (79 FR 23142 at believed because e-liquids do not including any component, part, or
23152). contain tobacco leaf, such products accessory of a tobacco product. An e-
should be regulated differently than liquid made or derived from tobacco
I. Applicability of Section 901 cigarettes and traditional smokeless meets this definition and, therefore, is
In the preamble to the NPRM, FDA tobacco products. subject to FDA’s chapter IX authorities.
stated that the rule applies to all (Response) With this rule, FDA is E-liquids that do not contain nicotine or
products that meet the definition of deeming all products that meet the other substances derived from tobacco
‘‘tobacco product’’ under section 201(rr) definition of ‘‘tobacco product,’’ may still be components or parts and,
of the FD&C Act and any future including e-liquids, to be subject to the therefore, subject to FDA’s tobacco
products that meet the definition. FDA tobacco product authorities in chapter control authorities, if they are an
stated that e-cigarettes meet the IX of the FD&C Act, to address the assembly of materials intended or
definition of ‘‘tobacco product.’’ public health concerns associated with reasonably expected to be used with or
(Comment 160) Many comments them. The FD&C Act does not include for the human consumption of a tobacco
seeking to exclude e-cigarette products any requirement that a product contain product and do not meet the definition
from the scope of the deeming rule ‘‘tobacco leaf’’ to meet the definition of of accessory.
stated that Congress only meant for FDA ‘‘tobacco product’’ and be deemed (Comment 165) Some comments tried
to regulate products with the greatest under this final rule. As stated to compare pipes and rolling papers
threat (i.e., cigarettes and smokeless previously, FDA is not requiring that (which are required to smoke tobacco)
tobacco products). They stated that ENDS and the other newly deemed with e-cigarettes (which are required to
regulating all tobacco products as products comply with all of the ‘‘vape’’ e-liquids), stating that e-
strictly as cigarettes are regulated is not requirements of part 1140 at this time. cigarettes should not be regulated. They
warranted and that the rigid application (Comment 163) Some comments indicated that, unlike rolling paper
of the Tobacco Control Act is not suggested that we need more which is ‘‘intended for human
consistent with public health objectives. toxicological, epidemiological, and consumption’’ and therefore a tobacco
(Response) FDA disagrees. Congress behavioral studies before deeming e- product component, a pipe is ‘‘non-
gave FDA immediate authority over cigarettes under section 901. Other consumable’’ and should not be
certain tobacco products (i.e., cigarettes, comments stated that FDA must regulate considered a tobacco product
smokeless tobacco, cigarette tobacco, e-cigarettes despite not having the level component. They said that, like pipes,
and roll-your-own tobacco) and the of scientific evidence that is available e-cigarettes are ‘‘non-consumable
authority to deem other products for most conventional tobacco products. products’’ and, therefore, are not
components or parts of tobacco products tanks, and open systems) and other cannot use the Tobacco Control Act
and not subject to regulation. They also components or parts because framework to regulate them.
stated that only the e-liquid is the manufacturers of such products would (Response) FDA agrees that there are
consumable product and should be the not have adequate resources to comply many differences among the products in
only part of the e-cigarette subject to with the requirements of the law. the ENDS category. However, there are
regulation. (Response) FDA disagrees. FDA is not many differences among combusted
(Response) The definition of ‘‘tobacco banning any tobacco product under this tobacco products as well. For example,
product’’ as set forth in section 201(rr) final rule. Rather, FDA is extending its many cigars are wrapped in whole
of the FD&C Act includes all authority to regulate such products tobacco leaf, whereas cigarettes are not.
components, parts, and accessories of under section 901 of the FD&C Act. Waterpipe tobacco is consumed in a
tobacco products (except for raw Manufacturers of ENDS products were manner very different from the
materials other than tobacco used in on notice that they could be considered consumption of cigarettes and cigars.
manufacturing a component, part, or FDA-regulated tobacco products since The differences among these products
accessory of a tobacco product). FDA the enactment of the Tobacco Control do not affect the Agency’s ability to
interprets components and parts of a Act and the issuance of the Sottera regulate them in accordance with the
tobacco product to include any decision shortly thereafter. See section requirements of the Tobacco Control
assembly of materials intended or VIII.K for additional discussion Act.
reasonably expected: (1) To alter or regarding the Sottera case. Therefore, J. Definitions
affect the tobacco product’s FDA disagrees with any comments
performance, composition, constituents Several comments suggested that we
referring to this rule as banning any
or characteristics; or (2) to be used with add definitions specific to e-cigarettes
categories of tobacco products.
or for the human consumption of a and their components and parts.
(Comment 168) Some comments Comments stressed the importance of
tobacco product. Both e-cigarettes and stated that FDA does not have the
pipes meet this definition. Thus, such defining terms broadly enough to ensure
authority to regulate the ingredients that all manufacturers of the finished
products are subject to FDA’s chapter IX can be used in e-liquids.
authorities as a result of this rule. products or components and parts of the
(Response) FDA clarifies that, finished products are covered by the
(Comment 166) Many comments
stated that FDA lacks any type of although it will not be directly definitions.
meaningful justification for deeming e- regulating the individual ingredients in (Comment 170) Some comments
cigarettes because e-cigarettes do not e-liquids at this time, sections 905 and suggested that FDA clearly identify
represent the same level of public health 910 of the FD&C Act give FDA authority nomenclature and constituents of ENDS
threat as cigarettes. They claimed that to review and consider ingredients in products because ENDS is a much
FDA has the burden of showing a making determinations on SE reports broader category than e-cigarettes.
rational basis for regulation and that the and PMTAs (i.e., the Agency will look Similarly, some comments stated that
lack of data showing that these products at ingredients within a specific e-liquid not defining these products would fail
do not cause harm cannot serve as a and determine whether the overall to address the exploding market of e-
basis for regulating them. In addition, tobacco product meets the statutory cigarettes and their e-cigarette
some comments stated that FDA has no standard for marketing authorization). components and parts. They also stated
justification for regulating products In addition, section 904 requires that an ENDS definition is necessary so
simply because they may deliver manufacturers to submit a listing of all State and local governments can use
nicotine. They likened such authority to ingredients added by the manufacturer consistent definitions.
imposing onerous regulations on to the tobacco, paper, filter, or other part (Response) FDA agrees that there is an
caffeine, another plant-derived of each tobacco product by brand and by expanding market of tobacco products
chemical. quantity in each brand and subbrand, that meet the FD&C Act definition of
(Response) FDA disagrees. FDA is and section 915 of the FD&C Act ‘‘tobacco products.’’ However, FDA does
deeming these products to address authorizes FDA to issue a regulation to not believe it is necessary to define
public health concerns (79 FR 23142 at require that ‘‘tobacco product individual categories of tobacco
23148 and 23149). ENDS are tobacco manufacturers, packagers, or importers products for purposes of this rule. In
products. As stated throughout this make disclosures relating to the results fact, by deeming ‘‘tobacco products’’
document, FDA has determined that of the testing of tar and nicotine through generally, it will help ensure that novel
deeming all products meeting the labels or advertising or other and future tobacco products are
statutory definition of ‘‘tobacco appropriate means, and make introduced into the market in an
product’’ will significantly benefit disclosures regarding the results of the appropriate and efficient manner. FDA
public health. We also note that by testing of other constituents, including may issue specific definitions at a later
merely deeming ENDS to be tobacco smoke constituents, ingredients, or time if it determines that doing so is
products, FDA is not imposing the same additives, that the Secretary determines appropriate.
level of regulation as is currently should be disclosed to the public to (Comment 171) At least one comment
imposed on cigarettes. For example, protect the public health and will not recommended that we establish a
restrictions on self-service displays, sale mislead consumers about the risk of definition of ‘‘vapor product’’ and
and distribution of nontobacco items, tobacco-related disease’’ (emphasis define it as ‘‘any noncombustible
and sponsorship of events will not added). tobacco-derived product containing
apply to ENDS at this time. FDA will (Comment 169) A few comments nicotine that employs a heating element,
consider the health effects of all noted the differences among products in power source, electronic circuit, or
products before determining whether to the ENDS category in contrast to the other electronic, chemical or
issue additional regulations. relatively uniform category of mechanical means, regardless of shape
(Comment 167) Many comments combusted tobacco products. Given or size, including any component
stated that the NPRM would ban these differences and the rapid cycle of thereof, that can be used to produce
virtually all of the e-liquid products and innovation and product development vapor from nicotine in a solution or
premium vaporizers (including mods, for ENDS products, they stated that FDA other form.’’ The comment stated that
several States have adopted variations of and describes conventional cigarettes Drug Administration, 627 F.3d 891 (D.C.
this definition and that it would provide (section 900(3) of the FD&C Act). If FDA Cir. 2010), which formed part of the
necessary clarity. finds reason to differentiate between the basis for FDA’s decision to deem
Likewise, at least one comment combusted and vaporized products for ‘‘tobacco products’’ subject to FDA’s
suggested that we establish a definition the purpose of future regulations, FDA tobacco product authorities. They took
of ‘‘alternative nicotine product,’’ which will issue a new NPRM to propose such issue with FDA’s description of the key
would be defined as ‘‘any definitions. In addition, FDA is aware points of the case, stating that FDA is
noncombustible tobacco-derived that some e-cigarettes are heated to a misreading the holding of Sottera to
product containing nicotine that is high enough level to cause combustion conclude that the court there held that
intended for human consumption, of the e-liquid. FDA has jurisdiction over e-cigarettes as
whether chewed, absorbed, dissolved or (Comment 174) At least one comment tobacco products because that question
ingested by any other means.’’ The suggested that FDA alleviate any was not presented in the case.
comment stated that several States have potential confusion between (Response) FDA’s analysis of the
adopted variations of this definition and conventional cigarettes and e-cigarettes Sottera decision in the proposed
that it would provide necessary clarity. by adding a third subsection to the deeming rule (79 FR 23142 at 23149 and
(Response) For the reasons explained proposed definition of ‘‘cigarette’’ to 23150) was correct. On December 7,
previously, FDA finds that it is not read as follows: ‘‘ ‘Cigarette’ (1) Means a 2010, the D.C. Circuit held that FDA has
necessary to add these definitions to the product that: (i) Is a tobacco product the authority to regulate customarily
codified for this final rule. and (ii) meets the definition of the term marketed tobacco products under the
(Comment 172) A few comments ‘‘cigarette’’ in section 3(1) of the Federal Tobacco Control Act and products made
suggested that FDA clarify the Cigarette Labeling and Advertising Act; or derived from tobacco that are
differences between ‘‘liquid nicotine’’ (2) includes tobacco, in any form, that marketed for a therapeutic purpose
and ‘‘e-cigarette liquid (or e-liquid).’’ is functional in the product, which, under the medical product provisions of
They noted that, throughout the NPRM, because of its appearance, the type of the FD&C Act. (See Sottera, Inc. v. Food
FDA referred to the liquid component of tobacco used in the filler, or its & Drug Administration, 627 F.3d 891
e-cigarettes as ‘‘e-cigarette liquid,’’ packaging and labeling, is likely to be (D.C. Cir. 2010).) On January 24, 2011,
which contains nicotine, flavorings, and offered to, or purchased by, consumers the D.C. Circuit denied the
other ingredients. However, in a few as a cigarette or as roll-your-own government’s petitions for rehearing and
instances, FDA referred to ‘‘nicotine tobacco; and (3) does not include a rehearing en banc (by the full court).
solutions’’ or ‘‘nicotine liquids.’’ They product such as nicotine [or products (See Sottera, Inc. v. FDA, No. 10–5032
asked that we clarify the difference to containing nicotine] that is derived from (D.C. Cir. Jan. 24, 2011) (per curiam).)
avoid confusion and unintended tobacco but does not contain tobacco.’’ On April 25, 2011, FDA issued a letter
coverage under chapter IX of the FD&C (Response) FDA finds that this to stakeholders indicating its intent to
Act. addition to the cigarette definition is deem additional tobacco products,
(Response) FDA agrees that unnecessary to prevent confusion including e-cigarettes, to be subject to
clarification is necessary. Liquid between the two product categories. The FDA’s authorities in chapter IX of the
nicotine does not have flavorings or definition of ‘‘cigarette’’ in § 1140.3 of FD&C Act.
other ingredients added to it. E-cigarette this final rule conforms to the definition (Comment 177) A few comments
liquid (or ‘‘e-liquid’’) is a liquid in section 900(3) of the FD&C Act. claimed that FDA had attempted to ban
containing nicotine, flavorings, and/or (Comment 175) One comment e-cigarettes, the Sottera decision
other ingredients. This final rule requested that FDA establish one established the legality of e-cigarettes,
regulates e-liquid and liquid nicotine common name for all vapor products, so and FDA’s purported ban was unlawful.
that is made or derived from tobacco. the manufacturers, distributers, (Response) FDA disagrees. Prior to the
(Comment 173) Some comments importers, and retailers of these Sottera case, FDA did not seek to ban
requested that FDA refer to ENDS products can comply with section e-cigarettes. Instead, FDA had detained
products as vapor products and use 903(a)(4) of the FD&C Act, which several shipments of e-cigarettes and
definitions that differentiate between requires that the manufacturer include their accessories offered for import by
the products that use combustion and an established name on the product Smoking Everywhere and Sottera, Inc.
those that use vaporization. They stated labeling. (doing business as NJOY) and
that this distinction is necessary (Response) At this time, FDA has not eventually refused admission into the
because the potential harms posed by established a common nomenclature for United States to two of Smoking
these products are different and this group of products. FDA will Everywhere’s shipments on the ground
consumers may believe that vapor consider these comments in that the products appeared to be
products are as dangerous as combusted determining whether future regulatory unapproved drug/device combination
smoking products. One comment action is appropriate. products. FDA did not attempt to
provided an example as to how to categorically ban e-cigarettes for sale in
recategorize tobacco products based on K. Sottera Decision the United States but, instead, sought to
their delivery method and combustion. In the NPRM, FDA explained that, as regulate them under its drug/device
Another comment requested that FDA set forth in the Sottera decision, e- authorities.
add ‘‘combustion’’ to the current cigarettes that are ‘‘customarily (Comment 178) A few comments
definition of cigarette to differentiate marketed’’ are tobacco products over stated that manufacturers are marketing
between combusted and vaporized which the Agency cannot exercise its e-cigarettes as cessation products and,
products. tobacco product authority until it therefore, they should be regulated as
(Response) For purposes of this finalizes a regulation that deems them to cessation products.
deeming regulation, FDA does not be subject to chapter IX of the FD&C (Response) As stated in the D.C.
believe it is necessary to distinguish Act. Circuit’s decision in Sottera, e-cigarettes
between vapor products and combusted (Comment 176) Some comments that are customarily marketed tobacco
products. The statutory definition of provided analysis of the D.C. Circuit’s products are subject to FDA’s tobacco
‘‘cigarette’’ was established by Congress decision in Sottera, Inc. v. Food and product authorities. If an e-cigarette
manufacturer wishes to market its the United States after February 15, A. Premarket Requirements (Sections
product for a therapeutic purpose, the 2007.’’ Therefore, establishments 905 and 910)
company would be subject to FDA’s engaged in mixing or preparing e- As stated throughout the document,
drug/device authorities and must liquids or creating or modifying manufacturers of newly deemed
submit an application to be marketed as aerosolizing apparatus for direct sale to products that are not grandfathered will
a medical product. consumers for use in ENDS are tobacco be required to obtain premarket
IX. Effect of Deeming Rule on Vape product manufacturers and, authorization of their products through
Shop Manufacturers consequently, are subject to all of the one of three pathways—PMTA, SE or SE
statutory and regulatory requirements exemption (sections 905 and 910 of the
Some comments requested applicable to manufacturers. FD&C Act). Therefore, ENDS retailers
clarification regarding the regulatory
The statute authorizes FDA to regulate engaged in mixing or preparing e-
status of an ENDS retail establishment
that sells e-liquids (sometimes known as the manufacture of all new products, liquids or creating or modifying
a vape shop). Such establishments sell including those manufactured at the aerosolizing apparatus will be required
a variety of products including ENDS, retail level. This is important to FDA’s to obtain premarket authorization for
replacement pieces, hardware, custom ability to protect the public health since each non-grandfathered product that
mixed e-liquids, and other related products manufactured at the retail they prepare for sale or distribution to
accessories. level pose many of the same public consumers. However, under the
If an establishment mixes or prepares health risks as those manufactured compliance policy laid out in section
e-liquids or creates or modifies upstream and possibly additional risks V.A, FDA does not intend to enforce,
aerosolizing apparatus for direct sale to related to the lack of standard during specified compliance periods,
consumers for use in ENDS, the manufacturing practices and controls. the premarket review requirements
establishment fits within the definition The introduction of statutory controls including for ENDS retailers that mix or
of ‘‘tobacco product manufacturer’’ in and oversight into a historically prepare the same e-liquids they have
section 900(20) of the FD&C Act and the unregulated market inevitably will lead been preparing and offering for sale as
combinations it mixes and/or prepares to some market change and of the effective daterule, or that create
are new tobacco products within the consolidation. FDA recognizes that, or modify aerosolizing apparatus
meaning of section 910(a)(1). For with the implementation of this final resulting in the same products they have
requirements not covered by the rule, vape shops that meet the definition been creating as of the effective date. An
compliance policy set forth in this of tobacco product manufacturer may initial compliance period, the length of
section, ENDS retail establishments that cease engaging in manufacturing which is dependent on the type of
meet the definition of a manufacturer activities rather than comply with application to be submitted, is intended
should refer to the compliance periods requirements for manufacturers under to provide additional time to prepare
in tables 2 and 3. As discussed in the this final rule. However, FDA notes that and submit premarket applications. In
Analysis of Impacts (Ref. 204), FDA such entities will have the option to addition, for the 12 months following
expects that most vape shops will stop continue operating solely as retailers, as this initial compliance period, FDA
mixing e-liquids (and preparing other some vape shops currently do. In intends to continue the compliance
new tobacco products) to avoid being addition, as noted earlier, FDA believes policy and does not intend to enforce
‘‘manufacturers’’ under the Tobacco that this policy (and the deeming rule as the premarket review requirements if
Control Act. a whole) will not stifle innovation but the firm has a pending submission. This
The definition of ‘‘tobacco product could, instead, encourage it. Over time, means that, during this 12-month
manufacturer’’ in section 900(20) FDA expects that its premarket review continued compliance period of FDA
includes ‘‘any person, including any authorities will spur creative evolution review, FDA expects that ENDS retailers
repacker or relabeler, who of any kind will sell only those products
and help to create a market where
manufactures, fabricates, assembles, that are (1) grandfathered; (2) authorized
available products present a lower risk
processes, or labels a tobacco product.’’ by FDA; or (3) tobacco products for
of user and population harm, provide a
Additionally, for purposes of section which the ENDS retailer or another
more consistent delivery under varying
905, the FD&C Act defines (upstream) manufacturer has submitted
conditions of use, are less likely to lead
‘‘manufacturing, preparation, a marketing application/submission to
compounding, or processing’’ to include to initiation of tobacco use, and/or are
FDA during the initial compliance
‘‘repackaging, or otherwise changing the easier to quit. In recent years, ENDS
period. (For PMTAs, the initial
container, wrapper or labeling of any products have proliferated in the
compliance period to submit is 24
tobacco product package from the absence of regulation, in some cases
months after the final rule effective
original place of manufacture to the resulting in a lack of quality control and
date.)
person who makes the final delivery or consistency, consumer confusion and FDA expects that this 12-month
sale to the ultimate consumer or user.’’ even availability of acutely toxic continued compliance period of FDA
Section 910(a)(1) defines a ‘‘new products. In this context, we expect that review will benefit manufacturers and
tobacco product’’ as ‘‘any tobacco changes in the market in response to retailers of newly deemed products,
product (including those products in regulation will have significant benefits including ENDS retailers, since
test markets) that was not commercially for public health and will be a net upstream manufacturers that submit
marketed in the United States as of benefit overall. applications will have a significant
February 15, 2007; or any modification As the ENDS market continues to incentive to make retailers aware of
(including a change in design, any evolve, it is important that FDA exercise their pending applications/submissions.
component, any part, or any constituent, its authority to oversee all Specifically, we expect that upstream
including a smoke constituent, or in the establishments engaged in manufacturer suppliers will inform
content, delivery or form of nicotine, or manufacturing activities and their ENDS retailers selling their products
any other additive or ingredient) of a products, in order to protect consumers whether the upstream manufacturer has
tobacco product where the modified and to carry out the public health submitted a premarket application for
product was commercially marketed in objectives of the Tobacco Control Act. such e-liquids and other ENDS products
within the initial compliance period to know whether a marketing month continued compliance period),
such that the retailers can benefit from application has been submitted and FDA expects that all ENDS retailers will
the continued compliance period while whether FDA has acted on an sell only those products that are either
FDA reviews such applications. FDA application. In addition, retailers may grandfathered or for which they have, or
expects that manufacturers will have an contact suppliers for relevant product an upstream supplier has, received
incentive to make retailers aware of information. Therefore, after 36 months premarket authorization.
which products are the subject of from the effective date (i.e., at the end
applications, which will enable retailers of the initial compliance period plus 12-
TABLE 4—COMPLIANCE POLICY FOR PREMARKET REQUIREMENTS—ENDS RETAIL ESTABLISHMENTS

Beyond 36 months after the rule goes
0–24 months after the rule goes into effect 24–36 months after the rule goes into effect into effect
FDA does not intend to enforce premarket au- FDA does not intend to initiate enforcement The compliance period no longer applies,
thorization requirements for e-liquid products action for e-liquid products that retailers mix even if the final mixture has a pending mar-
that retailers mix and sell without marketing and sell where a marketing application has keting submission/application. All products
authorization, provided that final mixture is been submitted and is still pending for the for which a marketing submission/applica-
the same as a product the retailer was selling final mixture. tion is pending are subject to enforcement
or offered for sale as of the effective date. action.
As stated previously, because product is likely to be used alone or from significantly increased efficiencies
products manufactured at the retail together with other legally marketed and reduced costs for complying with
level pose many of the same public products and the public health the statute. Such a system prevents and
health risks as those manufactured implications of those likely uses. FDA reduces duplication and allows for
upstream, and possibly additional risks, has issued a draft guidance on PMTAs manufacturer reliance on confidential or
it is important to enforce the statutory for ENDS, published concurrently with sensitive non-public information while
requirements for all new products, even this final rule, which, when finalized, maintaining its confidentiality, thus
those currently manufactured by ENDS will explain FDA’s current thinking saving time and reducing burdens for
retailers. regarding some appropriate means of multiple manufacturers. Because of the
In general, the FD&C Act provides addressing the premarket authorization nature of upstream supply of many
three pathways that manufacturers may requirements for newly deemed e- components for ENDS products,
use to seek market authorization for a liquids and hardware/apparatus especially e-liquids, FDA anticipates
new product: The premarket tobacco components. FDA intends to act as that commercial incentives will be
product application pathway, the SE expeditiously as possible with respect to sufficient to drive manufacturer reliance
pathway, and the exemption from SE all new applications, while ensuring on the system of master files. We also
pathway. FDA anticipates that most that statutory standards are met. note that at present, FDA understands
manufacturers of e-liquids and To reduce research burdens and that, based on the Agency’s review of
apparatus components/complete increase efficiency for ENDS retail publically available information as
delivery systems will seek authorization establishments that file applications, discussed in section III.C of the Analysis
through the PMTA pathway. To obtain FDA suggests that ENDS retail of Impacts (Ref. 204), the number of
marketing authorization under the establishments use master files entities engaged in upstream production
PMTA pathway, manufacturers are whenever possible. By obtaining of liquid nicotine and flavors
required to establish, among other permission from a master file holder, specifically developed for use with e-
things, that permitting their product to manufacturers could reference extensive liquids is small, in the range of seven to
be marketed would be appropriate for ingredients lists and constituent testing thirteen entities (see earlier discussion
the protection of the public health. In that they otherwise would be required in response to comment 34). Given the
establishing this, manufacturers should to perform themselves for marketing current marketplace, the master file
take into account, and FDA will authorization. To facilitate this process, system is likely to prove widely
consider, the ways in which the new elsewhere in this issue of the Federal appealing and widely utilized by the
product is likely to be used. For Register, FDA is announcing the ENDS industry, reducing burden
example, PMTAs for these products availability of a final guidance to significantly.
should contain information on whether provide information on how to establish In addition, FDA intends to open
the product is likely to be used alone or and reference a TPMF. This information public dockets for uniquely identified
together with other legally marketed will help applicants of newly deemed compounds likely to be used in an e-
tobacco products (such as available products prepare premarket and other liquid product, such as propylene
delivery systems), as well as the type regulatory submissions because they can glycol, glycerin, nicotine, colorants, and
and range of the other products with reference information in TPMFs rather flavoring agents. FDA intends to invite
which it is likely to be used. than develop the information on their stakeholders to submit to the docket
While the statutory standard will own. information regarding specific
apply to all products for which a PMTA Given the anticipated availability and compounds, including data, studies, or
is filed, FDA expects that different use of master files (as discussed in a other files, such as data on individual
classes of products may have differing separate, final guidance published health effects of inhalation exposure,
likelihoods of success in meeting the concurrent with Deeming), which animal study data examining exposure
standard, by virtue of their expected allows manufacturers to rely on the data to varying levels of compounds within
use. As stated previously, to meet the and analysis submitted to FDA by e-liquids, or testing the impact of
statutory standard, PMTAs should separate entities, FDA anticipates that temperature on changes to the aerosol
contain information on whether a manufacturers will, over time, benefit constituents. This information could
then be used to help support 3-year compliance period, even if the for small-scale tobacco product
applications for premarket review, for HPHC guidance and the section 915 manufacturers), FDA, for an additional
example, generating information on regulation are issued well in advance of 6 months following the end of the
HPHCs in ENDS products that is then that time. generally applicable compliance period,
submitted as part of a PMTA. does not intend to enforce against those
C. Registration and Product Listing
small-scale tobacco product
B. Ingredient Listing and HPHC (Section 905)
manufacturers (including ENDS retail
Requirements (Section 904 and 915) Section 905 of the FD&C Act requires establishments) who submit the
As of the effective date of this rule, every person who owns or operates an required information.
the ingredient listing requirements of establishment engaged in the
section 904 of the FD&C Act will apply ‘‘manufacture, preparation, E. Office of Small Business Assistance
to manufacturers of the newly deemed compounding, or processing of a Under section 901(f) of the FD&C Act,
products, including ENDS retail tobacco product’’ to register its one of FDA’s initial activities upon
establishments that mix or prepare e- establishment with FDA and submit a passage of the Tobacco Control Act was
liquids or create or modify aerosolizing listing of its tobacco products to the to establish the OSBA within CTP to
apparatus for sale or distribution. At Agency. If an ENDS retail establishment assist small tobacco product
this time, FDA intends to limit engages in these activities, section 905 manufacturers and retailers in
enforcement to finished tobacco requires the establishment to register complying with the law. FDA
products. FDA does not at this time and list its products with FDA in recognizes that the issuance of this final
intend to enforce these requirements for accordance with this section. These deeming rule, including the clarifying
manufacturers of components and parts requirements apply under the statute for information noting that ENDS retail
of newly deemed products that are sold all distinct products manufactured, and establishments are manufacturers
or distributed solely for further they enable FDA to assess the landscape subject to this rule, may result in many
manufacturing into finished tobacco of products manufactured by these additional small tobacco product
products. This means that FDA entities. If ENDS retail establishments entities contacting OSBA for assistance.
generally intends to enforce these are mixing or preparing e-liquids or Accordingly, FDA intends to hire
requirements with respect to ENDS creating or modifying aerosolizing additional OSBA staff to provide
retail establishments that mix or prepare apparatus for direct sale to consumers, assistance to small tobacco product
e-liquids or create or modify then they will have to list each e-liquid entities wherever possible.
aerosolizing apparatus for sale or combination that they sell. It will be the
distribution directly to consumers but responsibility of the ENDS retail X. Regulation of Other Categories of
not to distributors who sell components establishment, as a manufacturer, to Products
for further manufacturing. However, if determine how many and which FDA is finalizing this rule to deem all
the upstream distributor submits an products they plan to manufacture. For products that meet the definition of
ingredient list for a particular product, shops that prepare an expansive array of tobacco product in section 201(rr) of the
FDA does not intend to enforce the custom mixes, with many gradations of FD&C Act (except accessories of newly
ingredient listing requirement against an flavor, nicotine strength or other deemed tobacco products) to be subject
ENDS retailer with respect to that characteristic, this would mean to FDA’s tobacco product authorities. In
particular product. We note that FDA identifying, listing, and reporting addition, as stated in the NPRM, any
also intends to issue a guidance ingredients for a large number of future tobacco product that meets the
regarding HPHC reporting under section distinct products. In reality, however, definition in section 201(rr) (except
904(a)(3), and later a testing regulation we expect that such entities will elect to accessories of newly deemed tobacco
as required by section 915, with enough narrow the list of combinations they sell products) will also be subject to FDA’s
time for manufacturers to report given (with more limited distinctions in authorities under chapter IX of the
the 3-year compliance period for HPHC strength and flavor, etc.), since such a FD&C Act. Regulation of the newly
reporting. Section 904 (a)(3) requires the narrowing will allow them to continue deemed tobacco products is intended to
submission of a report listing all providing custom products and a variety address the public health concerns
constituents, including smoke of options while simplifying their related to these products. A summary of
constituents, identified as harmful or reporting. However, since the time and the comments regarding dissolvables,
potentially harmful (HPHC) by the cost of listing each additional mixture is gels, pipe tobacco, waterpipe tobacco,
Secretary. Section 915 requires the expected to be very low, the reduction other alternative products, and future
testing and reporting of the constituents, will not necessarily be significant. In tobacco products is discussed as
ingredients, and additives the Secretary addition, any narrowing may reflect a follows. FDA’s responses to the
determines should be tested to protect reduction in products that are listed but comments are also included.
the public health. The section 915 are not actually sold.
testing and reporting requirements A. Nicotine in Newly Deemed Products
apply only after FDA issues a regulation D. Tobacco Health Document Comments were split as to the health
implementing that section, which it has Submissions (Section 904) risks of nicotine and its impact on adult
not yet done. Until these testing and Section 904(a)(4) of the FD&C Act tobacco product users.
reporting requirements have been requires each tobacco product (Comment 179) Many comments
established, newly deemed tobacco manufacturer or importer, or agent stated that nicotine is addictive, and all
products (and currently regulated thereof, to submit all documents that products containing nicotine pose a
tobacco products) are not subject to the relate to health, toxicological, health threat to youth. Some also stated
testing and reporting provisions found behavioral, or physiologic effects of that nicotine can have detrimental
under section 915. As noted elsewhere current or future products, their effects on the cardiovascular system and
in this document, FDA does not intend constituents (including smoke promotes lung carcinomas (Refs. 15,
to enforce the reporting requirements constituents), ingredients, components, 205). Other comments noted that it is
under section 904(a)(3) for newly and additives. As discussed in section generally accepted that nicotine is not
deemed products before the close of the IV.D (discussing the compliance policy directly responsible for tobacco-related
death and disease (Ref. 206) and that the may have lasting adverse consequences 5 years actually do quit. In high-income
Surgeon General has stated that it is the for brain development (id.). Some countries, about 7 out of 10 adult
toxic substances in tobacco products studies also have found that nicotine smokers say they regret initiating
(not the nicotine) that cause almost all can have detrimental effects on the smoking and would like to stop (Ref.
tobacco-related death and disease (Ref. cardiovascular system and potentially 213).
9). disrupt the central nervous system In addition, FDA agrees that there are
(Response) FDA agrees that nicotine is (Refs. 14, 15). (See also section VIII.C data suggesting that the adolescent brain
the primary addictive substance in discussing the increase in poisoning due is more vulnerable to developing
tobacco products, as stated in the to accidental nicotine ingestion.) nicotine dependence than the adult
proposed deeming rule (79 FR 23142 at (Comment 180) FDA received a large brain and that there is evidence to
23180). The Surgeon General has long number of comments discussing the suggest that these brain changes are
recognized that nicotine is the primary addictive nature of nicotine and the permanent (Refs. 49, 214). The Surgeon
pharmacologic agent of tobacco that can impact of nicotine on adolescents. General reported that ‘‘most people
be absorbed into the bloodstream and Several comments stated that research begin to smoke in adolescence and
cause addiction (Ref. 1 at 6–9). In indicates that the adolescent brain is develop characteristic patterns of
addition, the Surgeon General has stated more vulnerable to nicotine addiction nicotine dependence before adulthood’’
that addiction to nicotine is the than the adult brain. The comments (Ref. 3). These youth develop physical
‘‘fundamental reason that individuals noted that researchers have found that, dependence and experience withdrawal
persist in using tobacco products, and ‘‘most likely owing to its ongoing symptoms when they try to quit
this persistent use contributes to many development, the adolescent brain is smoking (id.). As a result, addiction to
diseases’’ (Ref. 2 at 105). While nicotine more vulnerable to the effects of nicotine is often lifelong (Ref. 4).
does not directly cause most smoking- nicotine than the adult brain. Additionally, youth and young adults
related diseases, addiction to the Adolescents progress faster to nicotine generally ‘‘underestimate the tenacity of
nicotine in tobacco products sustains dependence than adults, find nicotine nicotine addiction and overestimate
tobacco use, leading to the ingestion of more rewarding, underestimate the risks
their ability to stop smoking when they
the toxic substances in combusted of smoking, and are more influenced by
choose’’ (Ref. 5). For example, one
tobacco products and tobacco smoke smoking behavior in their social
survey revealed that ‘‘nearly 60 percent
(Ref. 14). However, nicotine, in low milieu.’’ (Refs. 207, 208). One comment
of adolescents believed that they could
doses, is given in different routes of noted that animal research showing the
smoke for a few years and then quit’’
administration as nicotine replacement adolescent brain is particularly
(Ref. 7). Research conducted in animal
therapies to help consumers to stop vulnerable to nicotine addiction, and
models have indicated that exposure to
smoking, when approved for such that adolescents are also less susceptible
substances such as nicotine can disrupt
purposes. to withdrawal symptoms, creating an
While the inhalation of nicotine (i.e., adolescent brain development and may
all-reward, no-regret system for
nicotine without the products of psychostimulant use (Refs. 209, 210, have long-term consequences on
combustion) is of less risk to overall 211). Another comment noted that the executive cognitive function and on the
public health than the inhalation of U.S. Surgeon General has found that key risk of developing a substance abuse
nicotine delivered by smoke from symptoms of nicotine dependence— disorder and various mental health
combusted tobacco products, limited such as withdrawal and tolerance— problems as an adult (Ref. 8). This
data suggests that the pharmacokinetic develop in adolescents following even exposure to nicotine can also have long-
properties of inhaled nicotine can be minimal exposure to nicotine. term results on decreasing attention
similar to nicotine delivered by Additionally, the comment stated that performance and increasing impulsivity
combusted tobacco products. Thus, the Surgeon General’s 2012 report cites which could in turn promote the
inhaled nicotine from a non- one study following occasional maintenance of nicotine use behavior
combustible product may be as adolescent smokers that found that a (id.).
addictive as inhaled nicotine delivered large proportion experienced at least B. Dissolvables
by combusted tobacco products. one symptom of nicotine dependence
Researchers recognize that the effects upon quitting, even in the first 4 weeks FDA noted in the NPRM that it was
from nicotine exposure by inhalation after initiating monthly smoking (at proposing to deem certain dissolvable
are likely not responsible for the high least two cigarettes within a 2-month products (i.e., those dissolvable
prevalence of tobacco-related death and period) (Ref. 49 at 24, citing Ref. 212). products that do not currently meet the
disease in this country (Refs. 10, 11). (Response) FDA agrees that given definition of ‘‘smokeless tobacco’’ in
Although nicotine has not been shown their developmental stage, and the fact section 900(18) of the FD&C Act because
to cause the chronic disease associated that brain maturation continues into the they do not contain cut, ground,
with tobacco use, the 2014 Surgeon mid-twenties, adolescents and young powdered, or leaf tobacco and instead
General’s report noted that there are adults are more uniquely susceptible to contain nicotine extracted from
risks associated with nicotine (Ref. 9 at biological, social, and environmental tobacco). We explained that little
111). For example, nicotine at high influences to use and become addicted evidence is available to ascertain the
enough doses has acute toxicity (id.). to tobacco products. If individuals do pharmacological properties and harmful
Nicotine exposure during fetal not start using cigarettes by age 26, they effects of dissolvable tobacco products
development has lasting adverse are unlikely ever to smoke (Ref. 3). or compare them with FDA-approved
consequences for brain development Research shows that 87 percent of nicotine replacement products or other
(id.). Nicotine also adversely affects established adult smokers began tobacco products. We also noted that
maternal and fetal health during smoking before the age of 18 (Ref. 9). An certain dissolvable smokeless tobacco
pregnancy, contributing to multiple analysis by the WHO of studies products, given their candy-like
adverse outcomes such as preterm performed among final-year high school appearance, have the potential for
delivery and stillbirth (id.). Further, students in the United States suggests unintended poisonings. FDA deems
data in animal models suggest that that fewer than two out of five smokers these dissolvable products with this
nicotine exposure during adolescence who believe that they will quit within final rule.
(Comment 181) Comments stated that promote and sustain addiction. They cigarette tobacco products are safe
FDA should not rely on a study also indicated that dissolvable tobacco alternatives to cigarettes.
investigating flavored tobacco products products have a higher average pH than
D. Pipe Tobacco
in young adults as evidence that other tobacco products, increasing the
dissolvables are more attractive to amount of absorbable nicotine. FDA proposed to cover pipe tobacco
children. They indicated that this study (Response) FDA acknowledges that with this deeming rule. FDA indicated
is inapplicable because it only looked at information about harmful or that pipe tobacco smokers have a risk of
behaviors of people 18 years or older. potentially harmful constituents in such tobacco-related disease similar to the
(Response) The cited study (Ref. 54) products is sparse, but studies indicate risk of those who inhale cigar smoke or
assessed the prevalence of flavored that the level of nicotine in dissolvable smoke cigarettes (Ref. 221). The Surgeon
tobacco products (including products may differ from cigarettes and General also found that pipe and cigar
dissolvables) in individuals 18 and may lead to nicotine addiction (Ref. smokers experience oral and laryngeal
older, which encompasses both young 217). These studies support the public cancer risks similar to that of cigarette
adults and adults. The study stated that health need to regulate all dissolvable smokers (Ref. 222). FDA is deeming
the products’ packaging looks like tobacco products. pipe tobacco with this final rule.
candy packaging and the products often (Comment 187) A few comments
(Comment 185) Comments stated that
are sold next to candy. FDA believes provided suggestions as to how FDA
dissolvable tobacco products are safer
that these factors cause confusion should define pipe tobacco in this final
than other tobacco products and have
regarding the safety of these novel rule to differentiate it from roll-your-
lower levels of nitrosamines than snus
tobacco products for adult consumers as own tobacco. For example, comments
or snuff and just slightly higher levels
well as children (Ref. 215). In addition, suggested FDA define pipe tobacco to
than some NRTs (Ref. 218). They also include the moisture measured at the
this study cited an additional study that provided information that evaluated
concluded that sugar preference is time of packing, the amount of reducing
plasma nicotine levels, heart rates, and sugars, and the fact that it does not use
greater in youth and young adults (Ref. reduction in cigarette cravings, and
53). Accordingly, FDA believes it was reconstituted sheet tobacco or expanded
found that the levels in certain leaf tobacco as part of the blend. Others
appropriate to cite to this study as dissolvables were similar to the levels in
evidence supporting FDA’s concerns suggested FDA define the term based on
NRTs (Ref. 219). the ‘‘consumer’s reasonable perception
with certain dissolvable products.
(Comment 182) Some comments (Response) While a continuum of of the product’’ or include language
expressed concerns regarding possible nicotine-delivering products exists, stating that it is ‘‘suitable for use and
confusion between dissolvable tobacco deeming all tobacco products will likely to be offered to, or purchased by,
products and candy and the possibility enable the Agency to collect information consumers as tobacco to be smoked in
of inadvertent poisonings. about the ingredients and the health and a pipe.’’ Comments also requested that
(Response) FDA agrees that the candy- behavioral effects of these products. FDA enforce against the misuse of pipe
like appearance of some dissolvable These products are ‘‘tobacco products’’ tobacco as roll-your-own tobacco,
products may result in accidental with the potential to addict users and regardless of whether it defines pipe
poisonings. As FDA discussed in the harm children, particularly given their tobacco, because mislabeled pipe
NPRM, data from 2010 indicates that candy-like appearance, and are subject tobacco already meets the definition of
13,705 tobacco product ingestion cases to FDA’s tobacco control authorities cigarette tobacco or roll-your-own
were reported and more than 70 percent upon the effective date of this final rule. tobacco.
of those cases involved infants under a FDA also notes that NRTs are regulated (Response) FDA disagrees. The
year old (Ref. 215). Although it is products and subject to premarket Agency finds that it is not necessary to
unclear exactly how many of these cases review by FDA. define pipe tobacco in this rule. FDA
involved dissolvables, smokeless C. Gels also notes that it has issued Warning
tobacco products (in all forms, Letters for products bearing the package
including dissolvables) were the second As proposed, FDA is deeming description of ‘‘pipe tobacco,’’ but that
most common tobacco product ingested nicotine gels with this final rule. are sold or distributed for use as
by children, after cigarettes (id.). (Comment 186) Some comments cigarettes for the purposes of chapter IX
(Comment 183) Some comments agreed that nicotine gels should be of the FD&C Act due to the fact that,
mentioned that dissolvable tobacco subject to FDA’s chapter IX authorities because of its appearance, the type of
products may be easily confused with under the FD&C Act. In support of their tobacco used in the filler, or its
NRTs and, therefore, should be argument, they provided studies packaging and labeling, it is suitable for
regulated. showing that children and young adults use and likely to be offered to
(Response) The Agency finds that are more susceptible than adults to consumers as cigarettes, and/or likely to
FDA regulation of all dissolvable nicotine poisoning through the skin be purchased by consumers for making
products under chapter IX of the FD&C (Ref. 220). cigarettes or intended for use in
Act will help to alleviate potential (Response) With this final rule, FDA cigarettes. FDA will continue to do so as
confusion about the safety and use of is finalizing its proposal to deem all circumstances warrant.
these products. Products that contain ‘‘tobacco products’’ including nicotine (Comment 188) Comments stated that
nicotine derived from tobacco, are gels, which are absorbed through the when consumers use pipe tobacco for its
intended for human consumption, and skin. In addition to meeting the intended use, it does not have the same
are not marketed for therapeutic definition of ‘‘tobacco product,’’ public health concerns as other tobacco
purposes, are subject to FDA’s tobacco nicotine gels can be addictive and lead products. They also stated that pipe
product authorities under chapter IX of to use of other tobacco products that tobacco users are only a small
the FD&C Act. have well-documented risks of tobacco- percentage of adults and that only 0.2
(Comment 184) Comments provided related death and disease. Regulating percent of minors indicate that they are
unpublished data (Ref. 216) indicating these products also will help, among dual users of pipe tobacco and cigarettes
that dissolvable tobacco products other things, to address consumers’ (Ref. 9). They stated that based on these
deliver nicotine levels sufficient to unsubstantiated beliefs that non- differences, some of the automatic
deeming provisions should not apply to E. Waterpipe Tobacco (Response) FDA remains concerned
pipe tobacco. For example, they claimed The NPRM included waterpipe about the potential for dual and
premarket review requirements should tobacco as an example of a tobacco polytobacco use, particularly among
not apply to pipe tobacco, because product that would be covered under youth and young adults. As the North
manufacturers make changes to this deeming rule. We noted concerns Carolina research shows, a noncigarette
maintain consistent taste for older regarding the safety of waterpipe tobacco product (like waterpipe
populations and not to create ‘‘new’’ tobacco given the nicotine and tobacco) can be the first product used by
products. carcinogens in waterpipe tobacco new tobacco users and there is concern
Other comments disagreed, citing smoke, and the availability of waterpipe such users could continue using the
evidence of the dangers of pipe tobacco, tobacco in a variety of flavors that could initial product or transition to cigarettes
as discussed in the NPRM (79 FR 23142 be appealing to youth and young adults. or other tobacco products. There is also
at 23156 and 23168). They also FDA’s final rule includes waterpipe the concern that existing users could
expressed concerns that extended use of tobacco in the scope of products subject become dual users. Accordingly, it is
pipe tobacco releases significant to FDA’s tobacco control authorities. critical to deem these noncigarette
amounts of secondhand smoke into the (Comment 190) One comment tobacco products and place restrictions
environment. requested that FDA clarify whether the upon them that are appropriate for the
term ‘‘hookah’’ refers to the waterpipe protection of the public health,
(Response) FDA disagrees that pipe including age and identification
or the tobacco used in the waterpipe.
smoking is not a public health issue. As (Response) In the NPRM, FDA restrictions to help prevent youth use of
we stated in the NPRM, studies of pipe generally used the term ‘‘hookah’’ to these products.
tobacco smokers have found that their mean waterpipe smoking and ‘‘hookah
risk of tobacco-related disease is similar 2. Popularity
tobacco’’ as the tobacco used in the
to the risk in those who inhale cigar waterpipe. Waterpipe smoking may also (Comment 193) Many comments
smoke or smoke cigarettes (Ref. 221). be referred to by other names such as expressed concern about the growing
The Surgeon General also previously shisha or narghile. To alleviate any use of waterpipe tobacco, particularly
found that pipe and cigar smokers confusion in this final rule, FDA has among young adults. For example, they
experience oral and laryngeal cancer referred to ‘‘waterpipe smoking’’ and noted that the percentage of young
risks similar to that of a cigarette smoker ‘‘waterpipe tobacco’’ to cover all types adults aged 18 to 24 who use waterpipe
(Ref. 222). While the Surgeon General’s of tobacco smoking using a waterpipe. tobacco (7.8 percent) is significantly
report does indicate that pipe tobacco (Comment 191) At least one comment higher than adult use (1.5 percent) (Ref.
smokers may have a lower risk of expressed concern about the public 224). A few comments suggested that
developing cardiovascular disease than health risk of herbal waterpipe tobacco, FDA overestimated this trend.
cigarette smokers, pipe tobacco users which they assert has the same levels of
still are at risk for these diseases, and (Response) FDA agrees with the many
toxicant exposure but without nicotine. comments that supported regulation of
those who use both cigarettes and pipe (Response) FDA’s tobacco product
tobacco may have even higher levels of waterpipe tobacco and noted the
authorities under chapter IX of the
risk due to their usage patterns (Ref. 9 increase in use among young adults.
FD&C Act do not extend to substances
at 428). Moreover, researchers have Waterpipe tobacco use continues to
that are not made or derived from
found that when compared with increase in popularity, particularly
tobacco (like herbal waterpipe tobacco),
individuals who have never used among college students, with as many as
because they do not meet the definition
tobacco, pipe smokers have an increased 40 percent reporting ever using
of ‘‘tobacco product’’ under section
risk of death from cancers of the lung, waterpipe tobacco and 20 percent
201(rr) of the FD&C Act.
oropharynx, esophagus, colorectum, reporting use (i.e., use within the past
1. Dual and Polytobacco Use 30 days) on some college campuses
pancreas, and larynx, and from coronary
heart disease, cerebrovascular disease, (Comment 192) Many comments (Refs. 25, 26).
and COPD (Refs. 32, 221). expressed concern about the growth in 3. Harms
dual and polytobacco use among youth
(Comment 189) A few comments (Comment 194) Many comments
and young adults. For example, the
expressed concern that retailers who supplemented the data in the NPRM
North Carolina Public Health
blend pipe tobacco would be subject to regarding the dangers of smoking
Association submitted a preliminary
all FD&C Act requirements for waterpipe tobacco. For example, they
analysis of the 2013 NCYTS, which
manufacturers, preparers, compounders, referred to several studies showing
indicated that 19.1 percent of high
or processors of tobacco products, such significant nicotine, carbon monoxide,
school students reported using two or
as premarket review, and registration more tobacco products and that 88.4 and other carcinogen intake during
and listing. These comments requested percent of high school students who waterpipe use (e.g., Refs. 225, 226, 227,
that retailers blending up to either 3,000 currently are using waterpipe tobacco 228). Further, in studies involving the
pounds or 5,000 pounds of pipe tobacco reported using at least one other tobacco use of waterpipes in a hospital research
per year be exempt from the product. Some comments noted that ward, researchers found greater carbon
requirements of the law that apply to dual use of waterpipe tobacco and monoxide exposure and a different
manufacturers. cigarettes is more prevalent than pattern of carcinogen exposure for
(Response) All entities that meet the exclusive waterpipe tobacco use and waterpipe tobacco smokers (when
definition of ‘‘tobacco product that waterpipe tobacco users typically compared to cigarette smokers), and
manufacturer’’ in section 900(20) of the smoke cigarettes with greater intensity concluded that exposure to tobacco
FD&C Act, including retail than nonwaterpipe tobacco users (Ref. smoke toxicants during waterpipe use is
establishments that blend pipe tobacco, 222). In fact, dual use of waterpipe similar qualitatively (though not
are subject to and must comply with all tobacco and cigarette use is one of the quantitatively) to cigarette smoke (Refs.
applicable statutory and regulatory most common tobacco use profiles 229, 230). Comments concluded that
requirements for tobacco product found in young adults age 18 to 24 years waterpipe users have a significant risk
manufacturers. (e.g., Ref. 223). of smoking-related diseases, but the
magnitude of the risk depends upon the day, the product presents significant contains many of the same carcinogens
extent of the use. health risks and is appropriately and heavy metals as cigarette smoke (79
(Response) FDA agrees with this included in the scope of this rule. FR 23142 at 23156 and 23157). In
assessment and that it supports addition, given that waterpipe tobacco
finalizing its proposal to include 4. Addiction
smoking sessions last significantly
waterpipe tobacco in the scope of this (Comment 196) Some comments longer than smoking a cigarette,
rule. claimed that waterpipe tobacco smokers smoking waterpipe tobacco could
(Comment 195) Many comments do not get addicted and, therefore, there potentially be even more dangerous
included data regarding the increased is no need for FDA to regulate waterpipe than smoking a cigarette (79 FR 23142
cancer risks associated with waterpipe tobacco. Others disagreed and claimed at 23156). Consequently, based on the
smoking. For example, researchers that waterpipe tobacco is addictive. various impacts on public health, FDA
identified significant associations These comments provided extensive believes regulation of waterpipe tobacco
between waterpipe tobacco use and data about the significant health effects is important.
esophageal squamous cell carcinoma (including nicotine and toxicant
and a 6-fold increase in risk of lung exposure) and the highly addictive F. Additional Novel and Future Tobacco
cancer from waterpipe tobacco use nature of waterpipe use (e.g., dual use) Products
(Refs. 231, 232). In addition, the (e.g., Ref. 233). In the NPRM, FDA proposed to deem
existence of tobacco-related toxicants in (Response) Waterpipe tobacco additional novel and future tobacco
waterpipe tobacco smoke may place contains nicotine, which is the primary products if the products meet the
users at risk for many of the same addictive chemical in tobacco products. definition of ‘‘tobacco product’’ in
diseases as cigarette smokers, including Researchers have observed nicotine section 201(rr) of the FD&C Act. FDA is
a risk of lung cancer and respiratory dependence characteristics in some finalizing this proposal here.
illness (e.g., Refs. 233, 234, 235, 236). users, including suppressed cravings to (Comment 198) Several comments
While some comments maintained that smoke and anxiousness (Refs. 238, 239, supported deeming all future tobacco
many of these users will use waterpipe 240), with one study showing that products. One comment requested that
tobacco only once in their lifetime, waterpipe tobacco use suppressed the future regulated products should
these products are growing in withdrawal symptoms just as cigarette include products that extend beyond
popularity with youth and young adults smoking suppresses withdrawal buccal or dermal absorption.
and cause tobacco-related death and symptoms (Ref. 240). (Response) Future products that meet
disease. 5. Misunderstanding the definition of ‘‘tobacco product’’
Other comments opposed FDA’s under section 201(rr) of the FD&C Act,
proposal to regulate waterpipe tobacco, (Comment 197) Consumers stated that including the requirement that they be
claiming that the dangers of waterpipe waterpipe tobacco should be regulated ‘‘intended for human consumption,’’ are
tobacco use are unsupported, that FDA given its appeal to youth and deemed subject to FDA’s chapter IX
has not adequately reviewed scientific adolescents’ belief that it is not as authorities as a result of this rule. A
studies, and that FDA ignored evidence. harmful as traditional cigarettes. They product may be intended for human
They also believed that use of agreed that a failure to regulate the consumption in a variety of ways, such
disposable mouth piece tips would proposed deemed products could as through the lungs or by buccal or
alleviate the risks of spreading reinforce consumers’ existing confusion dermal absorption. However, future
communicable diseases through and misinformation about these accessories of newly deemed products
waterpipe use. In addition, they products. However, other comments are not deemed subject to chapter IX as
indicated that FDA’s comparison of a stated that FDA’s concerns over youth’s a result of this rule.
waterpipe smoking session to smoking a misperception of the safety of certain (Comment 199) At least one comment
single cigarette is inherently flawed due tobacco products should not be a factor cautioned FDA that regulations for
to the different patterns of use of these that FDA should consider in deciding future products should be based on the
tobacco products. whether to regulate them. They stated continuum of risk to ensure that there
(Response) Although it is possible that regulation cannot remedy the fact is continued innovation to reduce harm.
that use of disposable mouth piece tips that certain youth affirmatively (Response) FDA recognizes the
could help alleviate the risks of disregard available safety information. existence of a continuum of nicotine-
spreading communicable diseases Comments noted that waterpipe tobacco delivering products and will continue to
through waterpipe use, the products users perceive this product to be much consider this continuum in regulating
nevertheless present a significant risk of less harmful that cigarette smoking (Ref. future tobacco products.
smoking-related diseases. Accordingly, 241), because they mistakenly think that (Comment 202) A few comments
FDA is finalizing its proposal to include the water filters out toxicants from the stated that FDA should not regulate
waterpipe tobacco in the scope of this smoke and the fact that waterpipe products with de minimis amounts of
rule. Further, although the products tobacco use is frequently exempted from nicotine derived from tobacco that may
have different use topographies, FDA clean indoor air laws. be used in cosmetics, food, animal feed,
continues to believe that a comparison (Response) While we continue to or other products, and for purposes not
between the toxicants emitted during a believe that alleviating misperceptions related to traditional tobacco use (such
waterpipe session and cigarette smoking is important, we note that the potential as protein). Additionally, they stated
is valid and indicative of the dangers to alleviate youth’s misperception that these types of products should not
associated with waterpipe use. In fact, regarding the toxicity of unregulated have to bear the warning, ‘‘This product
the WHO study group on tobacco tobacco products was only one of many is derived from tobacco.’’
regulation has found that a waterpipe public health benefits associated with (Response) With this final rule, FDA
session can be the equivalent of deeming tobacco products, as discussed deems all products meeting the
smoking more than 100 cigarettes (Ref. in the NPRM (79 FR 23142 at 23148 and definition of tobacco product, except for
237). Moreover, regardless of the 23149). Waterpipe smoking carries accessories of newly deemed products,
number of waterpipe tobacco users who health risks similar to smoking to be subject to FDA’s authorities under
use waterpipe tobacco for more than 1 cigarettes, and waterpipe smoke chapter IX of the FD&C Act.
Determinations about whether (2) Ingredient listing and HPHC provisions are applied mechanically
particular products meet this definition reporting requirements (sections 904 across all product categories. At least
would be made on a case-by-case basis. and 915 of the FD&C Act); one comment stated that the
However, animal feed is a veterinary (3) Registration and product listing adulteration and misbranding
product and not for human requirements (section 905 of the FD&C provisions should not apply to e-
consumption and, therefore, would not Act); cigarettes because there is no evidence
be a tobacco product. Products that (4) Prohibition against the use of that adulteration and misbranding
contain nicotine derived from tobacco ‘‘light,’’ ‘‘low,’’ and ‘‘mild’’ descriptors currently occurs with those products or
meet the definition of a tobacco product and products with other unauthorized causes any harm.
under the FD&C Act and are required to modified risk claims (section 911 of the (Response) The adulteration and
bear a health warning on packages and FD&C Act); and misbranding provisions of sections 902
in advertisements stating: ‘‘WARNING: (5) Prohibition of free samples of the and 903 of the FD&C Act will
This product contains nicotine. Nicotine proposed deemed products (21 CFR automatically subject all tobacco
is an addictive chemical.’’ For products 1140.16(d)). products to certain basic requirements.
that are made or derived from tobacco Comments regarding these provisions, For example, their labeling and
(but do not contain nicotine), and FDA’s responses to comments, are advertising cannot be false or
manufacturers may submit a as follows. misleading, which will help reduce
certification to FDA and, instead, bear (Comment 204) In the proposed consumer confusion and misperception.
the statement ‘‘This product is made deeming rule, FDA noted that it was FDA will be able to take enforcement
from tobacco.’’ See section XVI.H for taking this action to address the public action against any tobacco product that
additional information regarding this health concerns associated with the use does not meet these basic requirements.
certification. of tobacco products. Some comments For example, if a product is produced in
stated that health policies based on insanitary conditions or is
(Comment 203) One comment stated
tobacco use prevention and cessation contaminated, or if its labeling contains
that alternative nicotine products, such
are not sufficient to protect the public a misleading claim, it will be subject to
as nicotine toothpicks, have a net
health. enforcement action, including seizure
positive impact on the public health (Response) FDA is deeming products
because they pose fewer health and and injunction.
that meet the definition of ‘‘tobacco
safety risks than conventional cigarettes product,’’ except accessories of newly B. Sections 904 and 915—Ingredient
and could help addicted smokers deemed tobacco products, to address the Listing and Reporting of HPHCs
transition to less toxic tobacco products. public health concerns with these As stated in the NPRM, the newly
The comment argued that the regulatory products. In the NPRM, FDA included deemed products will be required to
burden for such products should be discussion of public health benefits to comply with the ingredient listing and
proportionately reduced. better inform the public about the likely HPHC reporting requirements of
(Response) While FDA recognizes the results of deeming these tobacco sections 904 and 915 of the FD&C Act.
existence of a continuum of nicotine- products. FDA intends to supplement FDA intends to issue a guidance
delivering products, all tobacco this final rule with regulations as regarding HPHC reporting, and later a
products are addictive and potentially appropriate to protect the public health. testing and reporting regulation as
dangerous and, therefore, should be required by section 915, with enough
subject to FDA regulation. Therefore, A. Sections 902 and 903—Adulteration time for manufacturers to report given
FDA is deeming all tobacco products and Misbranding the 3-year compliance period for HPHC
(except accessories of newly deemed In the proposed deeming rule, we reporting. As noted elsewhere in this
tobacco products) subject to the explained that the adulteration and document, FDA does not intend to
requirements of chapter IX of the FD&C misbranding provisions of sections 902 enforce the reporting requirements for
Act and requiring certain additional and 903 of the FD&C Act would subject newly deemed products before the close
provisions (i.e., minimum age and all tobacco products to certain basic of the 3-year compliance period, even if
identification, vending machine, and requirements. For example, their the guidance is issued well in advance
health warnings) for covered tobacco labeling and advertising cannot be false of that time.
products. FDA will continue to take this or misleading, which will help reduce (Comment 206) A couple of comments
continuum of nicotine-delivering consumer confusion and misperception. urged FDA not to require newly deemed
products into consideration as it The Agency can take enforcement action products to comply with the ingredient
contemplates future regulations of the against any tobacco product that did not and HPHC listing requirements. One
newly deemed products. meet these basic requirements. comment argued that such reports are
(Comment 205) A large number of useless for educating consumers, who
XI. Additional Automatic Provisions
comments discussed the applicability of will invariably use them in an attempt
Applicable to Newly Deemed Products
sections 902 and 903 of the FD&C Act to determine the relative risk of each
In addition to the requirement that to the newly deemed tobacco products. product. Another comment claimed that
non-grandfathered tobacco products Most comments expressed general the HPHC and ingredient listing
obtain authorization through one of the support for applying adulteration and requirements should be abandoned
three marketing pathways, several misbranding provisions to the newly because they are not helpful and the
provisions in the Tobacco Control Act deemed tobacco products. Others cost of producing these reports would
and its implementing regulations will supported the application of the destroy industry.
automatically apply to the newly provisions based on concerns that some (Response) FDA disagrees with these
deemed products as of the effective date e-cigarette manufacturers may not be comments. Ingredient and HPHC
of this final rule (79 FR 23142 at 23148 producing their products in sterile reporting assist FDA in better
and 23149). These provisions include: conditions. Several comments cautioned understanding the contents of regulated
(1) Adulteration and misbranding that the differences between the newly products. This information will assist
provisions (sections 902 and 903 of the deemed tobacco products might result FDA in assessing potential health risks
FD&C Act); in unwarranted restrictions if the and determining if future regulations to
address these health risks would be for currently regulated tobacco for cigars should require analysis of
appropriate. The FD&C Act directs FDA products, including holding public HPHCs in the tobacco (rather than the
to make certain HPHC information workshops, requesting and considering smoke) in a manner similar to that for
publicly available, but it must do so in Tobacco Products Scientific Advisory hand-rolling tobacco. They stated that
a way that is understandable and not Committee recommendations, HPHC smoke analysis is neither
misleading to lay persons. publishing draft and final lists in the available nor readily producible for
(Comment 207) Several comments Federal Register for public comment, most cigars. They also stated that
discussed ingredient and HPHC listing and providing a reasonable compliance smoking regimens recommended for
requirements in the context of small period for e-cigarette manufacturers. A collecting HPHC data for tobacco smoke
businesses and particular products. A few comments expressed the opinion were developed for cigarettes and
few comments urged FDA to exempt that FDA should establish separate lists suggested that cigars are inherently
small businesses that manufacture e- of HPHCs for each category of newly more variable than cigarettes. Finally,
cigarettes from the HPHC reporting deemed tobacco products and not they stated that the cigar smoke test
requirement because the testing would require HPHC reporting until the lists method recommended by the Centre de
impose a large financial burden on them and corresponding testing Coopération pour les Recherches
and would likely drive them out of methodologies are created and Scientifiques Relatives au Tabac in 2005
business. One comment countered these validated. Other comments stated that has produced more variable data than
arguments, urging FDA to require because not all deemed products are that obtained using the comparable test
manufacturers of all products to comply likely to have the same HPHCs as method for cigarettes, making it difficult
with the ingredient and HPHC listing currently regulated products, testing for to compare consistent test results for
requirements and not provide an all of the constituents would be cigars.
exemption for small businesses. The wasteful. (Response) FDA disagrees with the
comment argued that the size of a (Response) As discussed elsewhere in comments. In order to determine the
business does not change a product’s this document, the compliance period HPHC deliveries that each cigar
potential health impact and that the for HPHC reporting and testing is the provides, it is important that
health benefits of regulation far exceed effective date of this rule plus 3 years. manufacturers submit HPHC data on
the costs. FDA intends to issue a guidance smoke yields for cigars. HPHC
Other comments focused on regarding HPHC reporting, and later a quantities in cigar tobacco only would
ingredient and HPHC listing testing and reporting regulation as not provide a complete understanding
requirements for specific product required by section 915 of the FD&C of the toxicity of each cigar. As stated
categories. At least one comment Act, with enough time for by the comments, Centre de Coopération
expressed concern that HPHC testing manufacturers to report given this pour les Recherches Scientifiques
would disproportionately affect the compliance period. As noted elsewhere Relatives au Tabac (CORESTA)
premium cigar industry, which has a in this document, FDA does not intend published method 64 in 2005 that
high number of low-volume products, to enforce the reporting requirements for describes a smoking regimen for cigars.
and requested that the requirements not newly deemed products before the close It is not clear that the variability in cigar
apply to small batch or special release of the 3-year compliance period, even if HPHC yields will be greater than that for
products. One comment claimed that the guidance is issued well in advance cigarette yields. Variability in HPHC
many of the new tobacco products on of that time. smoke yields is dependent on the
the market, such as e-cigarettes, are (Comment 209) Several comments smoking regimen, analytical method,
virtually identical with the exception of suggested that manufacturers should be and batch-to-batch consistency in
flavoring and nicotine levels and required under section 904 of the FD&C product composition. Therefore, it is
recommended that FDA allow for these Act to include a statement of the expected that the variability in HPHC
products to be grouped together for the ingredients and/or nicotine smoke yields from some cigarettes will
purposes of HPHC testing. concentration on their product labeling exceed that for cigars. In any case, as
(Response) With respect to HPHC as a condition of sale. These comments with cigarettes, it is important to
testing of similar products, FDA indicated that consumers could use this understand the HPHC deliveries in cigar
recognizes that some manufacturers of information to select e-cigarette liquids smoke.
newly deemed products sell products in with decreasing nicotine content levels
various flavors or with varying levels of as part of a nicotine replacement C. Section 905—Registration and Listing
nicotine. Manufacturers of these therapy to quit smoking. As stated in the NPRM, manufacturers
products will be required to test each (Response) Sections 915(b) of the of the newly deemed products will be
variation for HPHCs, even where the FD&C Act and 206 of the Tobacco required to comply with section 905(b)
products are otherwise the same. At this Control Act give FDA authority to of the FD&C Act, which requires the
time, there is little known about the require the disclosure of nicotine and registration of any establishment
constituents of some newly deemed certain other information on labeling engaged in the manufacture,
products. HPHC testing will allow FDA and by other means. FDA has not issued preparation, compounding, or
to track the level of HPHCs across regulations for the currently regulated processing of a tobacco product. In
different categories of flavors and by tobacco products and did not propose addition, they must comply with section
nicotine level. FDA’s compliance this in the proposed deeming rule. FDA 905(i) of the FD&C Act, which requires
policies for the HPHC requirements are will consider whether it should do so in registrants to submit a list of all tobacco
described elsewhere in this document. the future. To the extent the comment products that are being manufactured,
(Comment 208) Several comments is about ENDS marketed for smoking prepared, compounded, or processed for
stated that FDA should establish HPHC cessation, such a product would be commercial distribution. FDA must
lists and testing methodology before subject to FDA’s drug/device authorities issue a regulation before foreign
requiring HPHC testing. One comment and not subject to FDA’s tobacco establishments are required to comply
requested that FDA establish an HPHC product authorities. with these requirements.
list and testing methodology for e- (Comment 210) Some comments (Comment 211) Several comments
cigarettes in the same manner that it did suggested that any HPHC requirement stated that FDA should apply the same
requirements to both foreign and demonstrated that restricting modified advertising implies FDA approval or
domestic manufacturers of tobacco risk claims for these products would endorsement (e.g., use of the FDA logo
products, including manufacturers of advance its substantial interest in on labels or statements such as ‘‘made
the newly deemed products. They protecting the public health. A couple of in an FDA-approved facility’’) (Ref.
expressed concern that FDA has not yet comments argued that the brand names 151). As a result, the comments
issued a proposed registration and of newly deemed products that contain suggested a number of different actions
listing rule and has not provided a the descriptor ‘‘low,’’ ‘‘light,’’ or ‘‘mild’’ to curb these unsubstantiated or
timeframe for a final rule that would should be prohibited only where the misleading claims, including: (1)
apply these requirements to foreign descriptors specifically convey a Prohibiting direct and implied
establishments. They also stated that the modified risk claim. These comments therapeutic claims that e-cigarettes are
absence of registration and listing stated that where ‘‘low,’’ ‘‘light,’’ or effective cessation products unless there
requirements for foreign establishments ‘‘mild’’ is used and understood by is evidence; (2) using existing
creates incentives for manufacturers of consumers to describe something other enforcement authority to prohibit
the newly deemed products to move than a modified risk (such as the therapeutic, health, and cessation
their facilities overseas. product’s taste), restricting the use of a claims unless there is evidence of safety
(Response) As indicated in the brand name containing one of these and efficacy; (3) working with the FTC
Unified Agenda of Spring 2015 (Ref. terms would be unconstitutional, to prohibit such claims as false
242), FDA plans to issue a proposed arbitrary, and capricious because the advertising until such time as there is
registration and listing rule that would government does not advance any evidence of safety and efficacy; (4)
extend these requirements to foreign substantial interest by doing so. Other working with the FTC to introduce or
tobacco product establishments. In comments supported the application of strengthen disclosure rules on the
addition, upon the effective date of this section 911 to all newly deemed tobacco Internet (e.g., product reviews) to
final deeming rule, both foreign and products, with some comments promote transparency; and (5)
domestic manufacturers will be subject maintaining that certain e-cigarette prohibiting explicit or implicit
to, among other things, adulteration and companies are currently marketing their statements that e-cigarettes are approved
misbranding restrictions (sections 902 products using unauthorized modified or endorsed by FDA.
and 903 of the FD&C Act); requirements risk claims. (Response) Under section 911 of the
for ingredient listing and reporting of (Response) FDA disagrees with the FD&C Act, no person may introduce or
HPHCs for all tobacco products (section suggestion that subjecting the newly deliver for introduction into interstate
904 of the FD&C Act); and premarket deemed products to section 911 would commerce any MRTP without an order
authorization requirements (sections be an unconstitutional restriction of free in effect under section 911(g). Also, a
905 and 910 of the FD&C Act). speech. The Sixth Circuit upheld the tobacco product is misbranded if its
modified risk provisions against a First label, labeling, or advertising is false or
D. Section 911—Elimination of Low,
Amendment challenge to the facial misleading in any particular. Therefore,
Light, and Mild, and Other
validity of the statute in Discount by deeming ENDS and other tobacco
Unauthorized Modified Risk Claims
Tobacco v. FDA, 674 F.3d 509, 531–37 products, FDA is now authorized to take
Section 911 of the FD&C Act is one of (6th Cir. 2012). We discuss this issue in enforcement action against
the automatic statutory provisions that depth in section II.B.3.b. FDA has and manufacturers who sell and distribute
will apply to the newly deemed will continue to apply section 911 of the products with unsubstantiated MRTP
products on the effective date of this FD&C Act consistent with the First claims, or false or misleading claims on
regulation. The purpose of this section Amendment and will take all relevant their label, labeling, or advertising.
is to prohibit the introduction into facts into account on a case-by-case Additionally, under section 301(tt) of
interstate commerce of MRTPs, basis. the FD&C Act, anyone making explicit
including products the label, labeling, FDA agrees with comments that or implicit statements that a product is,
or advertising of which uses ‘‘low,’’ supported the application of section 911 among other things, ‘‘approved’’ or
‘‘light,’’ or ‘‘mild,’’ or other modified to all newly deemed products. ‘‘endorsed by FDA’’ is committing a
risk claims unless FDA issues an order Historically, certain users have initiated prohibited act. An ENDS product
authorizing their marketing. This and continued using certain tobacco claiming to be an NRT or otherwise
requirement will help consumers better products based on unauthorized marketed for therapeutic purposes is a
understand and appreciate the health modified risk claims and consumers’ drug or device subject to FDA’s
risks of the newly deemed products. In unsubstantiated beliefs about the regulations and laws for those products.
addition to any applicable premarket relative safety of these products. Section Additionally, the Agency will consider
review under section 910 of the FD&C 911 will prevent the use of these comments in the future, and, if
Act, if a manufacturer wishes to sell a unsubstantiated modified risk claims, FDA determines that it is appropriate,
MRTP, the company must submit an which may mislead consumers and lead will issue additional regulations.
MRTP application under section 911 them to initiate tobacco product use or
and receive an FDA order to legally to continue using tobacco when they E. Section 919—User Fees
market an MRTP. would otherwise quit. This will allow In 2014, FDA issued a final rule
(Comment 212) A number of for better-informed consumers and help regarding user fees for cigarettes, snuff,
comments discussed the application of to prevent the use of misleading chewing tobacco, and roll-your-own
the MRTP restrictions to the newly marketing targeted to youth tobacco, including the submission of
deemed products. Several comments populations. information needed to calculate and

argued, as a general matter, that (Comment 213) Many comments assess those user fees (79 FR 39302, July
subjecting the newly deemed products stated that e-cigarette companies make 10, 2014). In that final rule, FDA stated
to section 911 would be an direct and indirect health claims in the that if it deems cigars or pipe tobacco,
unconstitutional restriction of free marketing and promotion of their FDA would respond to the NPRM
speech because FDA either has no products (e.g., by posting customer comments regarding user fee provisions
substantial interest that would be comments and testimonials on their for cigars and pipes, and revise the user
advanced by such restrictions or has not Web sites) and that some e-cigarette fee regulations (79 FR 39302 at 39305).
Accordingly, elsewhere in this issue of leaves the retail establishment with a speech that is protected by the First
the Federal Register, FDA is issuing a free cigar (partially used or intact Amendment. The comment stated that
final rule revising the current user fee whole), this would constitute a ‘‘free while the court in Discount Tobacco
regulations. sample’’ in violation of the restriction City & Lottery v. United States upheld
(Comment 214) Some comments on free samples mandated by section the Tobacco Control Act’s sampling ban
supported applying the user fee 102 of the Tobacco Control Act. We on cigarettes, the evidence the court
provisions of the Tobacco Control Act to believe that, in most circumstances, used to uphold that ban does not
all tobacco products, explaining that other retail facilities, including ENDS support the same ban for the newly
application of user fee provisions to all retail establishments, can similarly deemed tobacco products. The comment
products is essential to ensure allow customers to touch, hold, and argued that FDA has presented no
uniformity and fairness across the smell their products without violating evidence that samples of these products
regulated entities. They also noted that the free sample ban. We note that lead to youth initiation and, therefore,
section 919(b)(3) of the FD&C Act states nothing in this policy should be the Agency would not be advancing a
that no manufacturer or importer of construed to alter or amend the legitimate government interest with this
tobacco products shall be required to regulation implementing the free sample ban. Additionally, the comment
pay a user fee in excess of the ban at § 1140.16. suggested that even if the ban did
percentage share of such manufacturer (Comment 215) A large number of advance a legitimate government
or importer. Accordingly, they argued comments discussed whether FDA interest, FDA could achieve the same
that FDA cannot assess user fees based should allow the continued distribution results through less restrictive means,
on the continuum of nicotine-delivering of free samples of the newly deemed such as by allowing samples in qualified
products. tobacco products. Most comments adult-only facilities, as FDA does with
(Response) Elsewhere in this issue of expressed general support for the ban on smokeless tobacco.
the Federal Register, FDA is issuing a free samples, citing concerns that such (Response) FDA disagrees with the
final rule regarding user fees for cigars samples serve as a gateway for youth assertions that the proposed ban on free
and pipe tobacco, including the tobacco initiation. Several comments samples would hurt businesses without
submission of information needed to argued that there is no reason to believe corresponding public health benefits or
calculate their user fee assessments. that free samples of pipe tobacco and that this prohibition impermissibly
These comments are addressed in that premium cigars encourage youth restricts commercial speech. This
rule. initiation because the samples are prohibition will eliminate a pathway for
F. Tobacco Control Act, Section 102— distributed almost exclusively in adult- youth to access tobacco products, which
Prohibition Against Free Samples only retail operations. One comment can help reduce youth initiation and
claimed that because epidemiological therefore short-term and long-term
In this final rule, FDA is not data suggest that the majority of morbidity and mortality resulting from
modifying the existing restriction on premium cigar smokers fall into a these products. The IOM has stated that
distributing free samples of tobacco category where there is no significant free samples of cigarettes ‘‘encourage
products (21 CFR 1140.16(d)). As a difference in the incidence of disease experimentation by minors with a risk
result, this restriction will prohibit the compared to never-smokers, banning free and cost-free way to satisfy their
distribution of free samples of newly free samples of premium cigars would curiosity’’ (Ref. 30). While the IOM was
deemed tobacco products, as required have no corresponding benefit even if it speaking in the context of cigarettes,
by section 102 of the Tobacco Control did reduce youth initiation. This FDA believes that the same rationale
Act. See section II.B.3.a for discussion comment also claimed that it would applies to the newly deemed products.
regarding the constitutionality of this similarly not help prevent youth access In addition, the U.S. Court of Appeals
free sample prohibition. because they assert that, as indicated in for the Sixth Circuit held that the free
FDA understands concerns from some a recent SAMHSA survey, there is no sample ban as applied to cigarettes does
retailers about the effect that a ban on evidence that youth obtain premium not violate the First Amendment. The
free samples would have on their ability cigars at all, let alone as free samples court recognized that FDA has provided
to promote new products. FDA wishes from retailers. ‘‘extensive’’ evidence that free tobacco
to clarify that allowing prospective Several comments, referring samples constitute an ‘‘easily accessible
adult buyers to smell or handle one of specifically to pipe tobacco, premium source’’ for youth (Discount Tobacco
the newly deemed products is not cigars, and e-cigarettes, stated that, in City & Lottery, Inc. v. United States, 674
considered distribution of a ‘‘free light of the lack of evidence that youth F.3d 509, 541 (6th Cir. 2012) (citing 61
sample’’ as long as the free product is obtain free samples of their products, FR 44396 at 44460, August 28, 1996),
not actually consumed, in whole or in banning these samples, which are a vital cert. denied sub nom. Am. Snuff Co.,
part, in the retail facility and the part of their industries, would only hurt LLC v. United States, 133 S. Ct. 1966
prospective buyer does not leave the sales and small businesses without a (2013)). Moreover, the panel
facility with a free tobacco product. For corresponding public health benefit. unanimously found that the ban
example, affording adult consumers the Comments referring to premium cigars ‘‘embodie[d] a narrow fit between the
opportunity to handle a cigar will give and pipe tobacco stated that free harm articulated and the restrictions
them the ability to feel the resistance of samples of these products are necessary employed’’ (id.). See section II.B.3.a for
the cigar’s structure and allow them to to entice adult consumers to purchase more detailed discussion of the
clearly see the color of the product, what are frequently unique and constitutionality of the free sample
which is an indication of the sometimes expensive products. prohibition.

fermentation period for the tobacco. Comments on e-cigarettes argued that, FDA understands concerns from cigar
Handling the product also will allow because their products are new, free retailers about the effect that a ban on
users to capture the aroma of a cigar and samples are necessary to convince free samples would have on their ability
the box (if the cigar is sold in a package). cigarette users to switch to them. to promote new products. FDA wishes
However, if the prospective buyer lights One comment argued that FDA’s to clarify that allowing prospective
and draws or puffs on the cigar to keep proposed ban on free samples adult buyers to smell or handle a cigar
it lit, or otherwise uses the free cigar or impermissibly restricts commercial is not considered the distribution of a
‘‘free sample’’ as long as the product is possible ban on flavored tobacco additional evidence emerges that
not actually consumed, in whole or in products are included below. flavored ENDS make it more likely that
part, in the retail facility and the (Comment 216) Many comments smokers switch completely to ENDS,
prospective buyer does not leave the suggested that FDA include a ban on such evidence submitted as part of a
facility with a free tobacco product. flavored tobacco products with this final PMTA would help support that
Affording adult consumers the rule. Other comments suggested that application, as part of the analysis of
opportunity to handle the product will FDA continue to allow the sale of fruit whether the marketing of the product is
give them the ability to feel the or candy-flavored e-cigarettes, because appropriate for the protection of public
resistance of the cigar’s structure, and they aid cigarette smokers in decreasing health.
allow them to clearly see the color of the cigarette use and in smoking cessation. Further, new data shows continued
product, which is an indication of the These comments generally relied on a growth in youth and young adult usage
fermentation period for the tobacco. It research article that found that most e- of flavored tobacco products. FDA has
also will allow users to capture the cigarette users switched between flavors balanced those concerns with
aroma of the cigar and the box (if the on a daily basis or within the day, with preliminary data showing that some
cigar is sold in a package). However, if former smokers switching more adults may potentially use flavored
the prospective buyer lights and draws frequently than current smokers, and ENDS to transition from combusted
or puffs on the free cigar or otherwise that respondents indicated that flavor tobacco use when developing the
uses the free cigar or leaves the retail variety was ‘‘very important’’ in compliance policy for premarket review.
establishment with a free cigar (partially reducing or quitting smoking (Ref. 62). (Comment 217) Many comments
used or intact whole), this would This survey also noted that almost half responded to FDA’s request for data,
constitute a ‘‘free sample’’ in violation of respondents indicated that a research, and information regarding the
of the ban on free samples mandated by reduction in available flavors would characteristics or factors it should
section 102 of the Tobacco Control Act. ‘‘increase craving[s] for tobacco consider in determining whether a
We believe that, in most circumstances, cigarettes and would make reducing or particular tobacco product is a
other retail facilities, including ENDS completely substituting smoking less ‘‘cigarette’’ as defined in section 900(3)
retail establishments, can similarly likely’’ (id.). Therefore, they believed of the FD&C Act and, consequently,
allow customers to touch, hold, and that FDA should not sacrifice adults’ subject to the prohibition against
smell their products without violating use of flavored tobacco products in an characterizing flavors, despite being
the free sample ban. attempt to prevent children from using labeled as a little cigar or other
flavored tobacco products. These
XII. Requests for Additional noncigarette tobacco product. Several
comments also noted that flavors are
Regulations Applicable to Newly comments stated that little cigars are
used in other legally marketed products
Deemed Products being marketed and used as cigarettes
including nicotine replacement
and, therefore, FDA should
therapies (NRTs), which are FDA-
In the NPRM, FDA noted that certain communicate that such products are
approved products.
provisions would automatically apply to (Response) FDA is not banning subject to the cigarette flavor ban. Other
the newly deemed products and that the flavored tobacco products with this final comments provided information
Agency was proposing additional deeming rule. To address concerns with regarding the differences between
restrictions that also would apply to the growing flavored cigar market and cigarettes and little cigars or other
covered tobacco products. FDA also its impact on youth and young adult noncigarette tobacco products and
noted that after the final rule becomes initiation with tobacco products, FDA is indicated that such products should not
effective, the Agency would have the announcing here that it intends to issue be subject to the cigarette flavor ban.
authority to issue additional regulations in the future a proposed product (Response) FDA understands and
applicable to the newly deemed standard that would prohibit appreciates comments regarding the role
products, including product standards characterizing flavors in all cigars, that flavored little cigars, or similar
under section 907 of the FD&C Act. including cigarillos and little cigars. products, might play on initiation of
Many stakeholders submitted comments As discussed in section VIII.F of this tobacco product use and dual use. FDA
and data regarding the need for document, we recognize that there is will continue to determine whether a
additional requirements and restrictions evidence that some individual former product is a ‘‘cigarette’’ under the FD&C
for the newly deemed products. Some of smokers may now report using ENDS Act and subject to the statutory flavor
these requests would require a separate (Ref. 24). However, the study referred to ban on a case-by-case basis.
NPRM, and they will help inform FDA in the comments (Ref. 62) examined (Comment 218) One comment stated
as it considers additional regulations for self-selected research subjects who were that section 907(d)(3) of the FD&C Act,
newly deemed products. recruited through an e-cigarette Web which prohibits FDA from banning
A. Ban on Flavored Tobacco Products site. All respondents were either former certain enumerated tobacco products,
smokers (91.2 percent) or current demonstrates that Congress did not
FDA received numerous comments smokers (8.8 percent); both groups had intend to grant FDA the power to ban
regarding flavored tobacco products, smoked on average 22 years before any tobacco product by any means,
including comments expressing beginning to use ENDS. The article did including by enacting a product
concerns regarding the impact of flavors not consider whether either the self- standard that would be a tantamount
on youth and young adults and selection or the demographic profile of ban of newly deemed products,
preliminary data regarding some the respondents might affect the especially when some of these products
individuals’ use of flavored ENDS applicability of its results to any larger present lower risks of death and disease
products to transition away from population. Moreover, the study did not than the specifically enumerated ones.
combusted tobacco use. FDA’s summary address the question of whether study Some comments also referred to the
of comments and data regarding participants would have increased difficulty in defining ‘‘characterizing
flavored tobacco products is included in cigarette use if there were no available flavor’’ in the context of instituting a
section V.B of this document. FDA’s flavored ENDS or if the variety of ban on flavored newly deemed tobacco
responses to comments regarding a flavored ENDS were limited. If products.
(Response) If FDA decides to issue a requirements of the APA when or suspend any provision of this final
product standard, it will do so in implementing such restrictions. rule, FDA would conclude that the
accordance with section 907 of the remaining parts continue to be valid. As
C. Nicotine Exposure Warnings
FD&C Act. Because FDA is not banning stated in section 5 of the Tobacco
flavored tobacco products with this final (Comment 222) Many comments Control Act, if certain applications of
deeming rule, it is not necessary to expressed concern about the increase in this rule to persons or circumstances
consider whether and how to define nicotine poisonings due to accidental (discussed in the preamble or otherwise)
‘‘characterizing flavor.’’ ingestion of e-liquids and offered are held to be invalid, application of
suggestions to address this issue: (1) Set such provisions to any other person or
B. Additional Access Restrictions a maximum nicotine content level for e- circumstance will not be affected and
(Comment 219) Some comments liquids; (2) require the use of child- will continue to be enforced to the
suggested that FDA require face-to-face resistant containers; (3) require a poison fullest extent possible. Each provision of
sales for all covered tobacco products, warning on the packaging and point of the rule is independently supported by
as it does for sales of cigarettes and sale for liquid-based products; and (4) data and analysis as described or
smokeless tobacco, as provided in set a limit on the allowable speed of referenced in this preamble and, if
§ 1140.14(a)(3). For example, they flow of the product from its container issued separately, would remain a
suggested that FDA ban self-service (e.g., by requiring a flow-restricting proper exercise of FDA authority.
displays for newly deemed tobacco apparatus on the opening of the
products. They expressed concern that container or requiring a rigid container XIV. Description of the Final Rule—
treating cigarettes and smokeless to prevent quick dispensing of product Part 1100
tobacco differently from other tobacco by squeezing the container). In the NPRM, FDA explained that
products would lead to confusion for (Response) FDA expressed similar new part 1100 would describe the scope
retailers and complicate retailer training concerns about the increase in nicotine of FDA’s authority over tobacco
programs. poisonings in the NPRM and section products, the requirements that would
(Response) FDA will continue to VIII.D. Once this final rule becomes apply to tobacco products, applicable
monitor this issue and, if it determines effective, FDA has authority to issue definitions, and the effective date of the
that it is appropriate for the protection additional regulations to address these rule. We consider and intend the
of public health to extend the self- concerns. In addition, FDA has issued extension of our authorities over
service display prohibition to newly an ANPRM prior to this deeming rule, tobacco products and the various
deemed tobacco products, the Agency seeking comments, data, research, or requirements and prohibitions
will issue a new NPRM in accordance other information that may inform established by this rule to be severable.
with the APA. regulatory actions FDA might take with
(Comment 220) Some comments respect to nicotine exposure warnings A. Section 1100.1—Scope
suggested that we simultaneously issue and the use of child-resistant packaging. FDA selects Option 1 with this final
this final rule with an ANPRM seeking Moreover, elsewhere in this issue of the rule, deeming all cigars (rather than a
additional information to draft a Federal Register, FDA has made subset), which has been applied
proposal that would apply the available draft guidance, which when throughout the codified text for parts
additional restrictions in part 1140 (e.g., final will describe FDA’s current 1100, 1140, and 1143. Therefore, this
ban on self-service displays, the sale thinking regarding some appropriate section now states that in addition to
and distribution of nontobacco items, means of addressing the premarket FDA’s authority over cigarettes, cigarette
and the sponsorship of events) to newly authorization requirements for newly tobacco, roll-your-own tobacco, and
deemed products. deemed ENDS products, including smokeless tobacco, FDA deems all other
(Response) FDA is taking this recommendations for nicotine exposure products meeting the definition of
comment under advisement. If FDA warnings and child-resistant packaging ‘‘tobacco product’’ under section 201(rr)
decides to issue such a proposal, the that would help to support a showing of the FD&C Act, except accessories of
Agency will comply with the that the marketing of a product is such other tobacco products, to be
requirements of the APA. appropriate for the protection of the subject to chapter IX of the FD&C Act.
(Comment 221) A few comments public health. The definition of ‘‘accessory’’ is now
requested that FDA regulate all included in § 1100.3 (as discussed in
dissolvables and other newly deemed XIII. Severability
section VI.A).
products in the same manner it This rule is being finalized with
regulates other tobacco products, several changes from the NPRM. B. Section 1100.2—Requirements
including application of all of the Specific comments regarding proposed Because FDA selected Option 1 for
marketing and advertising restrictions in codified language, and FDA’s responses the scope of the deeming rule, § 1100.2
part 1140. to those comments, are included in states that cigarettes, cigarette tobacco,
(Response) At this time, FDA is section VII. roll-your-own tobacco, smokeless
subjecting newly deemed products to In accordance with section 5 of the tobacco are subject to chapter IX of the
the automatic requirements and covered Tobacco Control Act, FDA considers FD&C Act and its implementing
tobacco products to the additional and intends the extension of its regulations. In addition, this section
provisions (i.e., age and identification authorities over all tobacco products states that FDA has deemed all other
requirements, vending machine and the various requirements and tobacco products, except accessories of
restrictions, and health warning prohibitions established by this rule to such other tobacco products, subject to
requirements) discussed in this final be severable. It is FDA’s interpretation chapter IX of the FD&C Act and its
rule. However, if FDA later determines and position that the invalidity of any implementing regulations.
that extending such marketing and provision of this rule shall not affect the
advertising restrictions to the newly validity of any other part of this rule. In C. Section 1100.3—Definitions
deemed products is appropriate and the event any court or other lawful FDA requested comment on
meets the applicable standard in section authority were to temporarily or definitions for cigar, covered cigar, and
906(d), FDA will comply with the permanently invalidate, restrain, enjoin, tobacco product. Because we are
selecting Option 1 deeming all cigars purpose of this part is to establish import, sell, or otherwise hold for sale
(rather than a subset) with this final restrictions on the sale, distribution, and comply with all applicable requirements
rule, comments regarding the definition access to covered tobacco products in in part 1140. The revisions to §§ 1140.10
of covered cigar are no longer relevant addition to those restrictions in place and 1140.14 clarify that the minimum
to this rulemaking. In addition, FDA for cigarettes and smokeless tobacco. age and identification requirements and
received many comments regarding Therefore, the final rule states that vending machine restrictions apply to
components, parts, and accessories, retailers of the newly deemed covered the newly deemed covered tobacco
including how they should be defined tobacco products may not sell them to products.
and the application of requirements to individuals under 18 years of age and Previously, § 1140.10 stated that each
these objects. We have added requires retailers of covered tobacco manufacturer, distributor, importer, and
definitions of ‘‘component or part’’ and products to verify the purchaser’s birth retailer is responsible for ensuring that
‘‘accessory’’ to this section. The date by reviewing the individual’s its products comply with all applicable
discussion of this language is included photographic identification. However, requirements under part 1140. FDA
in section VI.A. as noted in § 1140.14(b)(2)(ii), a retailer proposed to add ‘‘and covered tobacco
is not required to verify the age of any products’’ to the existing language of
XV. Description of the Final Rule—Part this section to clarify that the provision
person who is more than 26 years of age.
1140 also applies to ‘‘covered tobacco
In addition, § 1140.14(b)(3) prohibits the
Currently, part 1140 generally applies sale of covered tobacco products using products’’ as defined in § 1140.3. In
to cigarettes, cigarette tobacco, roll-your- an electronic or mechanical device such addition, FDA proposed that § 1140.10
own tobacco, and smokeless tobacco. as a vending machine, unless it is cover importers, because the Tobacco
FDA proposed additional provisions to located in a facility where the retailer Control Act defines ‘‘tobacco product
apply to ‘‘covered tobacco products’’ ensures that no person younger than 18 manufacturer’’ to include importers
(namely, the requirement to prohibit the years of age is present, or permitted to (section 900(20) of the FD&C Act),
sale and distribution of products to enter, at any time. FDA does not intend signaling Congress’ intent for tobacco
individuals under 18 years of age and for section 1140.14(b)(3) to prohibit the product importers to be subject to
the prohibition on vending machine sale of tobacco products via the Internet, requirements like those in § 1140.10.
sales except in adult-only facilities). As but the sale of covered tobacco products FDA is finalizing this section as drafted
stated elsewhere in this document, via any medium, including the Internet, in the NPRM.
‘‘covered tobacco product’’ means any must only be to persons 18 years of age E. Section 1140.14—Additional
tobacco product deemed to be subject to or older. Therefore, any sale of covered Responsibilities of Retailers
the FD&C Act pursuant to § 1100.2, but tobacco products over the Internet must
excludes any component or part that is comply with the minimum age and FDA proposed to divide this section
not made or derived from tobacco. FDA identification requirements in this rule. into responsibilities for retailers of
is finalizing these requirements without cigarettes and smokeless tobacco
substantive change. FDA intends to C. Section 1140.3—Definitions products and responsibilities for
update the current guidance documents In the NPRM, we sought comments on retailers of covered tobacco products.
for civil money penalties and frequently definitions of the following terms: Cigar, FDA is finalizing this section as drafted
asked questions to reflect that violations cigarette, cigarette tobacco, covered in the NPRM. Therefore, upon the
of health warning requirements may tobacco product, distributor, importer, effective date of this final rule,
lead to the issuance of civil money nicotine, package, point of sale, retailer, § 1140.14(a)(1) through (a)(5) will
penalties. We consider and intend the smokeless tobacco, and tobacco product. provide the retailer’s responsibilities for
extension of our authorities over FDA received many comments the sale of cigarettes and smokeless
tobacco products and the various regarding whether e-liquids and tobacco. Section 1140.14(b)(1) through
requirements and prohibitions components, parts, and accessories are (b)(3) will provide the retailer’s
established by this rule to be severable. tobacco products. FDA also received responsibilities for the sale of newly
many comments regarding the need to deemed products.
A. Section 1140.1—Scope define components, parts, and
F. Comments and Responses Regarding
The NPRM offered several accessories, which resulted in the
Minimum Age and Identification
amendments to part 1140 in order to addition of definitions of ‘‘component
Requirements
apply select existing sale and or part’’ and ‘‘accessory’’ in § 1140.3.
distribution restrictions, including age, The discussion of this language in In the NPRM, FDA sought comment
identification, and vending machine included in section VI.A. Further, we regarding whether to prohibit the sale of
provisions, to address youth access to revised the definition of ‘‘package’’ to newly deemed products to individuals
the deemed tobacco products. As refer to ‘‘package or packaging.’’ We also under 18 years of age and to require
currently written, part 1140 generally added a definition of ‘‘roll-your-own’’ to photographic identification for
applies to cigarettes, cigarette tobacco, provide further clarity to the definition individuals aged 26 and under (which
roll-your-own tobacco, and smokeless of ‘‘cigarette.’’ are the same requirements that currently
tobacco products. Accordingly, FDA is apply to cigarettes and smokeless
D. Section 1140.10—General tobacco). FDA discussed the benefits of
finalizing this rule to add the phrase
Responsibilities of Manufacturers, a uniform minimum age and
‘‘and covered tobacco products’’ to
Distributors, and Retailers identification requirement, including:
§ 1140.1(a) and (b) to ensure the
products are subject to select existing With the selection of Option 1, (1) Decreasing youth access to tobacco
restrictions and access provisions. We § 1140.10 now provides that products in another jurisdiction with
also have added language to § 1140.1(a) manufacturers, distributors, importers, less stringent requirements; (2)
to clarify the scope of § 1140.16(d). and retailers are responsible for addressing youth misperceptions that
ensuring that the covered tobacco tobacco products without minimum age
B. Section 1140.2—Purpose products (in addition to cigarettes and or identification requirements are safer;
This final rule adds ‘‘and covered smokeless tobacco) they manufacture, and (3) increasing the ease with which
tobacco products’’ to indicate that the label, advertise, package, distribute, retailers can comply with minimum age
and identification requirements for identification requirements for covered sales. FDA will consider these
covered tobacco products (79 FR 23142 tobacco products vary among the states, comments in the future and continue to
at 23160 23162). In addition, we a uniform age requirement would help assess whether additional access
expressed our intention to use an prevent youth from accessing tobacco restrictions would be appropriate.
aggressive nationwide enforcement products in a neighboring state with less (Comment 227) Several comments
program to increase compliance and stringent requirements. recommended that FDA impose stiff
deter youth consumption of tobacco (Response) FDA agrees with penalties for noncompliance with
products (79 FR 23142 at 23160). comments supporting the minimum age and identification
Nearly all comments supported a implementation of minimum age and requirements and institute youth
minimum age and identification identification requirements for covered tobacco prevention campaigns and other
requirement for the newly deemed tobacco products. As we noted in the actions to effectively reduce youth
tobacco products. FDA is finalizing NPRM, the goal of the minimum age access to tobacco products.
these requirements without change. restriction is to limit youth access to the (Response) As noted in the NPRM,
FDA also intends to update the current newly deemed tobacco products. FDA FDA believes that combining the
guidance documents for civil money concludes that the restrictions included minimum age and identification
penalties and frequently asked with this final deeming rule are restriction with comprehensive and
questions to reflect that violation of appropriate for the protection of the consistent enforcement, both at the
these provisions may lead to the public health because they will reduce Federal level and in partnership with
imposition of civil money penalties. A youth access to and, therefore, likely States, will decrease the likelihood of
summary of comments regarding these limit use of tobacco products. youth smoking initiation (79 FR 23142
provisions, and FDA’s responses, is (Comment 225) Several comments at 23161). In addition, FDA will
included in the following paragraphs. recommended that FDA raise the continue to invest in a number of public
(Comment 223) Many comments minimum age to purchase tobacco education campaigns to help educate
supported FDA’s proposal due to the products to 21 years old. They claimed the public—especially youth—about the
fact that many of the newly deemed that a higher minimum age would dangers of tobacco products.
products are easily available. For restrict youth access to social sources of (Comment 228) Several comments
example, they noted that tobacco tobacco products because minors tend recommended that FDA prohibit the
industry documents refer to the to have less contact in their social sale of tobacco product components,
increased frequency with which self- network with 21-year-olds than with 18- parts, and accessories (not just covered
service tobacco products are stolen, and year-olds (Ref. 244). They also suggested tobacco products), including ENDS, to
some of the proposed deemed products that the minimum age and identification minors under 18 years of age to provide
(e.g., cigars) are frequently sold in self- requirement should mirror the consistency across the country.
service displays (Ref. 243). They minimum age requirement for alcohol (Response) FDA disagrees. FDA
expressed concern that self-service and marijuana purchases in some States. concludes that the application of
displays increase the likelihood that (Response) FDA has determined that minimum age requirements and vending
minors will have access to tobacco minimum age and identification machine requirements to covered
products. restrictions, which will apply to all tobacco products, together with its
(Response) FDA agrees that the newly covered tobacco products, are regulation of components and parts of
deemed tobacco products are readily appropriate for the protection of public newly deemed products, will protect the
available to consumers. FDA finds that health. FDA also will continue to public from the dangers of tobacco use,
the age and identification restrictions provide prevention and tobacco product discourage initiation, and encourage
that are included in this final rule risk awareness campaigns targeted to cessation of use of such products.
(§ 1140.14) will help to limit youth youth and young adults. Although (Comment 229) A few comments
access to the newly deemed tobacco section 906(d)(3)(ii) precludes FDA from suggested that FDA prohibit cigar sales
products. In the event that FDA raising the minimum age of sale of to individuals under 18 years of age,
determines that extending the tobacco products, section 104 of the except for minors serving in the U.S.
prohibition on self-service displays Tobacco Control Act required FDA to military. They argued that there are
(§ 1140.16(c)) to the newly deemed conduct a study on the public health greater health hazards for military
products is appropriate and meets the implications of raising the minimum age personnel than using tobacco products.
applicable standard in section 906(d), of sale of tobacco products. This study’s (Response) We disagree with the
FDA will issue a new NPRM and seek report was published (Ref. 245) and can suggestion that we provide an exception
comment. be found at: http://www.iom.edu/ for minors in the military. Military
(Comment 224) Many comments Reports/2015/ personnel face the same risk of tobacco-
supported the minimum age and TobaccoMinimumAgeReport.aspx. related death and disease as civilians.
identification requirements for covered (Comment 226) Several comments As FDA stated in the preamble, cigars
tobacco products based on increased discussed Internet sales of tobacco can contain greater levels of nicotine
youth use of newly deemed products products. Some comments favored a ban than cigarettes; cigar smoking is strongly
and the impact of nicotine on youth. on Internet sales for all tobacco related to certain cancers; and in certain
They noted that, according to the CDC, products, some supported a ban on only circumstances, cigars may be as harmful
e-cigarette use among youth doubled certain tobacco products, and others to a person’s health as cigarettes (79 FR
from 2011 to 2012, with 1.78 million opposed a ban on Internet sales of any 23142 at 23151, 23156).
high school and middle school students tobacco products. (Comment 230) Some comments
having ever used e-cigarettes (Ref. 108). (Response) As explained elsewhere, suggested that retailers record and retain
Others noted that the 2012 Surgeon under this rule, retailers may not sell copies of each purchaser’s unexpired
General’s report stated that youth are covered tobacco products (through any driver’s license (if the document
more sensitive to developing nicotine medium, including the Internet) to includes a photo), an armed forces
dependence than adults (Ref. 49). In individuals under 18 years of age. FDA identification card, or a valid passport
addition, other comments stated that will continue to actively enforce the as an acceptable identification to verify
because minimum age and minimum age restriction for Internet a purchaser’s minimum age. Other
comments recommended that FDA preventing youth from gaining access to deemed tobacco products using
implement a registration requirement these products. methods similar to those found in the
for mail order sale of tobacco products (Comment 232) Several comments Prevent All Cigarette Trafficking (PACT)
and require carriers to verify that the suggested that FDA prohibit all vending Act of 2009 (which ensures the
seller sending out packages is registered machine sales of all tobacco products. collection of Federal, State, and local
before accepting the packages for (Response) FDA disagrees with tobacco taxes on cigarettes and
delivery. prohibiting all vending machine sales of smokeless tobacco sold via the Internet
(Response) The requirements for all tobacco products. Sections or mail order sales). Other comments
photo identification are included in 1140.14(a)(3) and 1140.14(b)(3) permit opined that neither the PACT Act nor
§ 1140.14(b)(2). Retailers may choose the sale of cigarettes and smokeless State laws have been effective in
any method of identification verification tobacco products and covered tobacco preventing youth access to tobacco
that complies with this provision. FDA products, respectively, in a non-face-to- products.
finds that these requirements are face exchange with the assistance of a (Response) Under this rule, retailers
appropriate for the protection of the mechanical device as long as the retailer may not sell covered tobacco products
public health and declines to adopt the ensures that no person younger than 18 (through any medium) to individuals
recommendations for additional years of age is present, or permitted to under 18 years of age. FDA will
requirements at this time. However, we enter, at any time. FDA is permitting continue to actively enforce the
will continue to assess whether adult-only facilities to sell tobacco minimum age restriction for mail order
additional requirements regarding products in a vending machine because sales and Internet sales. FDA will
identification are appropriate. these locations employ safeguards to continue to assess whether additional
prohibit entry to individuals less than access restrictions would be
G. Comments and Responses Regarding 18 years of age. FDA is not seeking to appropriate.
Vending Machines ban adult access to legally marketed (Comment 235) A few comments
Consistent with the minimum age and tobacco products. stated that because newly deemed
identification provisions, FDA proposed (Comment 233) Several comments tobacco products are generally not sold
to ban the sale of covered tobacco recommended that FDA subject tobacco in vending machines, there will be little
products in vending machines (i.e., product components, parts, and impact from the proposed vending
requiring face-to-face transactions in accessories (particularly e-cigarettes) to machine restrictions.
retail facilities) unless the vending the proposed vending machine (Response) FDA disagrees. As
machine is located in a facility where restrictions. These comments expressed discussed in the NPRM (79 FR 23142 at
the retailer ensures that individuals concern regarding exploding tanks and 23162), FDA expects that the vending
under 18 years of age are prohibited nicotine poisoning due to accidental e- machine restrictions will have a positive
from entering at any time. FDA is liquid exposure. impact by preventing some youth from
finalizing this requirement without (Response) FDA agrees that these accessing tobacco products. Therefore,
change in § 1140.14. Therefore, upon tobacco product components and parts FDA concludes that this restriction is
the effective date of this final rule, can pose public health concerns. At this appropriate for the protection of the
covered tobacco products, including time, FDA has determined that it is public health.
ENDS and cigars, may not be sold in appropriate for the protection of the (Comment 236) A few comments
electronic or mechanical devices such public health to restrict impersonal stated that FDA should permit tobacco
as vending machines unless the device modes of sale of nicotine-containing product sales through vending machines
is in an adult-only facility. This components and parts in vending in all locations. They noted that
restriction is appropriate for the machines. However, FDA has concluded technological advancements now allow
protection of the public health because that it is not warranted at this time to for accurate non-face-to-face age
it will eliminate one more method of impose the vending machine verification, including electronic age
youth access to tobacco products. restrictions on components or parts that and identity verification (EAIV)
A summary of the comments are not made or derived from tobacco as technology and that the PACT Act
regarding these provisions, and FDA’s they will only be able to deliver nicotine already requires retailers to verify a
responses to them, is included in the to users by combining them with tobacco product purchaser’s name, birth
following paragraphs. covered tobacco products that are date, and address through an EAIV
(Comment 231) Multiple comments subject to the vending machine database prior to accepting a delivery
supported restricting vending machines restriction (and, therefore, youth cannot order.
sales to adult-only facilities. They access). Accordingly, FDA believes that (Response) FDA disagrees. We
asserted that FDA’s discussion of this the public health will be protected by explained in the NPRM that other types
issue demonstrates that the vending applying the vending machine of vending machine restrictions, such as
machine restriction serves the stated restrictions to components and parts electronic locking devices on vending
public health purpose of the regulation. that contain nicotine or tobacco in order machines, have not sufficiently limited
Other comments stated that FDA’s to prevent youth access to these youth access to tobacco products (79 FR
rationale for this restriction for products. 23142 at 23162). In addition, vending
cigarettes and smokeless tobacco also (Comment 234) Some comments machines may be located in facilities
applies to the newly deemed tobacco suggested that the deeming rule include that are not as sophisticated as the
products. a ban on Internet sales. These comments common carriers or Internet sellers that
(Response) FDA agrees that there is a asserted that manufacturers and retailers are subject to the PACT Act, or these
public health benefit to limiting vending are not enforcing age verification retailers may not have the financial
machines to adult-only facilities. As we effectively and that youth are able to resources to update their vending
stated in the NPRM, studies show that purchase tobacco products when they machines to incorporate EAIV
youth are able to access tobacco are not in the physical presence of the technology. Therefore, FDA concludes
products in vending machines (79 FR seller. Several comments also that the vending machine restriction is
23142 at 23162). Therefore, the vending recommended that FDA require retailers appropriate for the protection of public
machine restrictions are important in to verify the age of purchasers of newly health.
XVI. Description of the Final Rule— cigarette tobacco, roll-your-own tobacco in this section to further clarify this
Part 1143 and covered tobacco products other process. This section now provides that
In the proposed deeming rule, FDA than cigars must include the following the certification statement can be
proposed to add part 1143, which warning statement on each product submitted by the tobacco product
would mandate the use of ‘‘required package and in each advertisement: manufacturer to FDA. FDA recommends
‘‘WARNING: This product contains that all data used to support the self-
warning statements’’ for covered
nicotine derived from tobacco. Nicotine certification, or copies of the data, be
tobacco products, as well as for roll-
is an addictive chemical.’’ The NPRM maintained at the manufacturing facility
your-own and cigarette tobacco, for
provided that a manufacturer could or another location that is reasonably
which health warnings are not already
submit a certification that its tobacco accessible to the manufacturer and to
required by Federal statutes or
product does not contain nicotine and any officers or employees duly
regulations. As stated throughout this
notify FDA that it intends to use the designated by the Secretary, which
document, FDA has selected Option 1
alternative warning statement: ‘‘This includes FDA employees. These data,
with this final rule. Therefore, these
product is derived from tobacco.’’ FDA including data not stored at the
requirements apply to all newly deemed
also proposed size and placement inspected facility, should be made
covered tobacco products, including requirements for the use of this warning
premium and other types of cigars. We readily available for copying or
statement on packages and in inspection by an officer or employee
consider and intend the extension of our advertisements.
authorities over tobacco products and duly designated by the Secretary.
Upon review of the comments, FDA is Manufacturers interested in submitting
the various requirements and revising the language of this warning to
prohibitions established by this rule to a certification statement may contact
read: ‘‘WARNING: This product CTP at 1–877–CTP–1373 for more
be severable. contains nicotine. Nicotine is an information regarding this submission.
A. Section 1143.1—Definitions addictive chemical.’’ The alternative Further, in response to comments, we
warning statement is also revised to added § 1143.3(d), which states that, if
In the NPRM, FDA sought comment read: ‘‘This product is made from
on definitions for the following terms: a product package is too small or
tobacco.’’ This warning will be required otherwise unable to accommodate a
Cigar, covered cigar, covered tobacco to appear on at least 30 percent of the
product, package, required warning label with sufficient space to bear such
two principal display panels of the information, it will be exempt from the
statement, and roll-your-own tobacco. package and at least 20 percent of the
As stated throughout this document, requirement to place the warning
area of the advertisement. We also
FDA has selected Option 1 as the scope statement directly on the product
added language to § 1143.3(a) to clarify
of this rule. Therefore, the definition of package if the warning appears on the
that the warning statement must be
covered cigar is unnecessary and has outer carton or other outer container or
printed in at least 12-point font size in
been removed from this section. We also wrapper or on a tag otherwise
order to be clear and legible.
added definitions of point-of-sale, Further, we added language to permanently affixed to the tobacco
retailer, and tobacco product. These § 1143.3(a)(3)(ii) to clarify when a product package. Under this provision,
terms are used in part 1143 and were retailer of any tobacco product covered the warning statement must be printed
already included in parts 1100 and by paragraphs (a)(1) and (2) of this using the specifications required in
1140. section will not be in violation of this § 1143.3(a)(1) and (a)(2). In these cases,
FDA received many comments section for packaging that does not the outer carton, outer container,
regarding the need to define comply with these requirements. This wrapper, or tag would serve as the
components, parts, and accessories, final rule provides that a retailer will location for the principal display
which resulted in the addition of not be in violation if the package: (1) panels. If a tag is used for the principal
definitions of ‘‘component or part’’ and Contains a health warning; (2) is display panels, both sides of the tag
‘‘accessory’’ in § 1140.3. The discussion supplied to the retailer by a tobacco must be visible to the consumer. The
of this language in included in section product manufacturer, importer, or warning statements must be printed on
VI.A. In addition, we included a distributor, who has the required state, both sides of the tag to comply with
definition of ‘‘cigarette tobacco’’ given local, or TTB-issued license or permit, § 1143.3(a)(2).
that the health warning requirements if applicable (consistent with the We also note that this requirement in
apply to covered tobacco products, roll- language in § 1143.5(a)(4)(ii)); and (3) is § 1143.3 applies to cigarette tobacco,
your-own tobacco, and cigarette not altered by the retailer in a way that roll-your-own tobacco, and covered
tobacco. We also have added a is material to the requirements of this tobacco products other than cigars. Both
definition of ‘‘principal display panels’’ section. cigarette tobacco and roll-your-own
to address comments suggesting that a In addition, in response to comments tobacco are defined in § 1143.1. This
definition was necessary to comply with regarding minimum font size for warning requirement does not apply to
this part. The term ‘‘principal display advertisements, we have revised smokeless tobacco products. Smokeless
panels’’ is defined as the panels of a § 1143.3(b)(2)(ii) to include a 12-point tobacco products must meet the
package that are most likely to be minimum font size for the warnings on warnings requirements in CSTHEA (15
displayed, presented, shown, or advertisements. We note that the U.S.C. 4401 et seq.).
examined by the consumer. warning also needs to occupy ‘‘the C. Section 1143.5—Required Warning
greatest possible portion of the warning Statements for Cigars
B. Section 1143.3—Required Warning
area set aside for the required text.’’

Statement Regarding Addictiveness of In § 1143.5, FDA proposed warnings
Therefore, a print advertisement would
Nicotine for the cigars that would be covered
require a much larger font size in order
Proposed § 1143.3 included a to comply with this requirement. under this final rule. In addition to the
requirement that any person who Given that comments expressed addictiveness warning, FDA proposed
manufactures, sells, offers to sell, uncertainty as to how the self- that all cigars (except those sold
distributes, or imports for sale or certification process in § 1143.3(c) individually and not in product
distribution within the United States, would work, we also included language packages) would be required to include
the following warnings on packages and larger font size in order to comply with required to place warnings directly on
in advertisements: this requirement. these product packages, retailers will be
• WARNING: Cigar smoking can For packages, the six warnings for required to post signage at the point of
cause cancers of the mouth and throat, cigars (five specifically for cigars and sale listing the six warnings (five
even if you do not inhale. the one addictiveness warning) will be specifically for cigars and one
• WARNING: Cigar smoking can required to be randomly displayed in addictiveness warning) on a minimum
cause lung cancer and heart disease. each 12-month period, in as equal a of 8.5 x 11 inch sign. The rule requires
• WARNING: Cigars are not a safe number of times as is possible on each that the sign be placed on or within 3
alternative to cigarettes. brand of cigar sold in product packaging inches of each cash register where
• WARNING: Tobacco smoke and randomly distributed in all areas of payment is made and the sign is
increases the risk of lung cancer and the United States. This random display unobstructed in its entirety and can be
heart disease, even in nonsmokers. and distribution must be done in easily read by each consumer making a
FDA also proposed size and placement accordance with a warning plan purchase.
requirements for the warning statements submitted to, and approved by, FDA.
on packages and in advertisements. FDA For advertisements, the warnings must D. Section 1143.7—Language
is finalizing these warning requirements be rotated quarterly in alternating Requirements for Required Warning
in accordance with Option 1 deeming sequence in each advertisement for each Statements
all cigars (rather than a subset). Further, brand of cigar in accordance with a
warning plan submitted to, and Consistent with section 3(b) of
FDA is adding an additional warning CSTHEA (15 U.S.C. 4402(b)), FDA
statement (WARNING: Cigar use while approved by, FDA. Warning plans must
be submitted for FDA review and proposed in § 1143.7 that the warning
pregnant can harm you and your baby.) statement appear in the English
with an optional alternative statement approval by responsible manufacturers,
distributors, importers, and retailers by language, with two exceptions. First,
(SURGEON GENERAL WARNING: under § 1143.7(a), if an advertisement
Tobacco Use Increases the Risk of 1 year after the date of publication of the
final rule (however, all other part 1143 appears in a non-English language
Infertility, Stillbirth and Low Birth publication, the required warning
Weight) as discussed in section requirements shall take effect 2 years
after the publication date of this final statement would be required to appear
XVI.H.16. in the predominant language (i.e., the
Therefore, the full list of required rule).
In the NPRM, FDA did not have a primary language used in the
warnings for use on cigar packages and
separate section (with its own effective nonsponsored content) of the
in cigar advertisements is as follows:
date) explicitly requiring the submission publication. Second, under § 1143.7(b),
• WARNING: This product contains
of warning plans with its own effective if an advertisement is in an English
nicotine. Nicotine is an addictive
date. Rather, the sections of part 1143 language publication but the
chemical.
requiring random display and advertisement is presented in a language
• WARNING: Cigar smoking can
distribution of warning statements for other than English, the required warning
cause cancers of the mouth and throat,
packaging and quarterly rotation of statement would be required to appear
even if you do not inhale. warning statements for advertisements
• WARNING: Cigar smoking can in the same foreign language as that
(for which FDA proposed a 2-year principally used in the advertisement.
cause lung cancer and heart disease. effective date) stated that such random
• WARNING: Cigars are not a safe FDA is finalizing this section as
display and distribution and quarterly proposed in the NPRM with one change;
alternative to cigarettes. rotation be done in accordance with a
• WARNING: Tobacco smoke given that FDA has noted throughout
warning plan submitted to and this document that the health warning
increases the risk of lung cancer and approved by FDA. Thus, those
heart disease, even in nonsmokers. requirements apply to advertisements in
provisions implicitly required that any medium, we have changed the
• WARNING: Cigar use while submission of the warning plan and
pregnant can harm you and your baby. references from ‘‘publication’’ to
approval by FDA be done prior to the ‘‘medium’’ in this section.
(Or, as an optional alternative statement: 2-year effective date by which
SURGEON GENERAL WARNING: manufacturers must comply with the E. Section 1143.9—Irremovable or
Tobacco Use Increases the Risk of plan. FDA has added § 1143.5(c)(3) to Permanent Required Warning
Infertility, Stillbirth and Low Birth specifically include the requirement to Statements
Weight.) submit a proposed warning plan. (See
The health warnings are required to FDA proposed that the warning
section XVI.H.17 for additional
appear on at least 30 percent of each of information regarding the warning plan statements for covered tobacco products
the two principal display panels of the requirement and timeframe for be indelibly printed on or permanently
package and on at least 20 percent of the submission.) affixed to packages and advertisements.
area of the print advertisements and The same warning statement FDA is finalizing this requirement
other advertisements with a visual requirements will apply to cigars sold without change.
component. As we did for individually and not in product F. Section 1143.11—Does Not Apply to
§ 1143.3(a)(2)(ii) and (b)(2)(ii), we added packages.15 However, instead of being Foreign Distribution
language to § 1143.5(a)(2)(ii) and
(b)(2)(ii) to clarify that the font used for 15 In general, pursuant to the Internal Revenue FDA proposed to limit the
warnings on packaging and Code at 26 U.S.C. 5751, a tobacco product cannot applicability of the health warning
be sold at retail unless it is in the package in which
advertisements must be at least 12-point the product is removed, upon payment of Federal
requirements by clarifying that they
font size in order to be clear and legible. excise tax, from the factory or from customs would not apply to manufacturers or
We note that the warning also must custody. Section 5751(a)(3) and TTB regulations at distributors of tobacco products that do
occupy ‘‘the greatest possible portion of 27 CFR 46.166(a) state that tobacco products may not manufacture, package, or import the
be sold, or offered for sale, at retail from such
the warning area set aside for the packages, provided the products remain in the
products for sale or distribution within
required text.’’ Therefore, a print packages until removed by the customer or in the the United States. FDA is finalizing this
advertisement would require a much presence of the customer. requirement.
G. Section 1143.13—Effective Date compliance with the warning label currently required to use them under
In the NPRM, FDA sought comment requirements under section 1143 is the FTC consent decrees, by providing
regarding the effective date of the health implemented as of the effective date of for random display on cigar packages
warning requirements. FDA proposed 24 months after the publication of the and rotation in advertisements, and by
that these requirements would take final rule. FDA intends to work with requiring point-of-sale warnings for
effect 24 months after the date that the manufacturers, importers, distributors, cigars sold individually that are not
final rule publishes in the Federal and retailers to get an approved warning packaged. The comment also noted that
Register and all products manufactured plan in place. Cigar entities may wish to the substance of each warning is
contact FDA to discuss the submission strongly supported by the available
on or after the effective date must
of their warning plans in order to make scientific evidence. However, several
include the required warning statements
the subsequent approval process more comments took issue with the proposed
on their labels.
orderly and efficient. See section warnings for premium cigars, claiming
This means that:
• After the effective date, no XVI.H.17 for additional information that they lack a sound scientific basis.
regarding the warning plan requirement. (Response) FDA finds there is a strong
manufacturer, packager, importer,
scientific basis to require health
distributor, or retailer of cigarette H. Comments and Responses Regarding warnings on cigar packages and in cigar
tobacco, roll-your-own tobacco, cigars, Required Warning Statements advertisements (as well as on signs for
or other covered tobacco products may unpackaged cigars), which was
advertise any such product if the 1. General
extensively discussed in the NPRM (79
advertisement does not comply with (Comment 237) Several comments FR 23142 at 23167 through 23170).
this rule; urged FDA to clearly define (Comment 239) Several comments
• After the effective date, no person ‘‘advertisement’’ in the final rule as it is stated that the NPRM is unclear
may manufacture for sale or distribution unclear what constitutes an regarding the requirement to develop
within the United States any such advertisement that must contain the and submit rotation plans for warnings
product the package of which does not required warning statements. At least signs required where cigars are sold
comply with this rule; one comment suggested that the final individually and not in a product
• Beginning 30 days after the effective rule contain language explaining that package. One comment stated that the
date, a manufacturer may not introduce any statement regarding the availability final rule should make clear that this
into domestic commerce, any such of tobacco products in a store does not obligation falls on cigar manufacturers
product, irrespective of the date of by itself constitute an advertisement. and not on retailers that sell cigars.
manufacture, if its package does not (Response) FDA does not believe it is Another comment stated that retailers
comply with this rule; necessary to include a definition of should be responsible for creating and
• After the effective date, a distributor ‘‘advertisement’’ in this final rule, but posting the point of sale signs.
or retailer may not sell, offer to sell, notes that for purposes of this rule, the (Response) To clarify, retailers of
distribute, or import for sale or term ‘‘advertisement’’ should be cigars sold individually and not in
distribution within the United States interpreted broadly and should be product packaging are not required to
any such product the package of which interpreted to include statements submit a warning plan for warnings on
does not comply with this regulation, regarding the availability of tobacco packages, because the warning signs
unless the covered tobacco product was products. posted at a retailer’s point-of-sale would
manufactured prior to the effective date; In addition, advertisements subject to include all six warnings applicable to
and this final rule may appear in or on, for cigars, as we have noted above in our
• After the effective date, however, a example, promotional materials (point- discussion of § 1143.5(c)(1). Cigar
retailer may sell covered tobacco of-sale or non-point-of-sale), billboards, retailers would be responsible for
products in packages of which do not posters, placards, published journals, creating and posting these signs in
have a required warning if the retailer newspapers, magazines, other accordance with § 1143.5(a)(3)(i)–(iv).
demonstrates it falls outside the scope periodicals, catalogues, leaflets, Therefore, there is no need to rotate
of this rule as described in brochures, direct mail, shelf-talkers, these health warnings, nor is it
§§ 1143.3(a)(3) and 1143.5(a)(4). display racks, Internet Web pages, necessary to submit a rotational warning
In addition to proposed § 1143.13, we television, electronic mail plan for them. However, manufacturers
added paragraph (b) indicating that the correspondence, and also include those must submit a warning plan for
requirement to submit a warning plan communicated via mobile telephone, advertisements, as the rule requires
pursuant to § 1143.5(c)(3), describing smartphone, microblog, social media manufacturers of all cigars to include
the random display and distribution of Web site, or other communication tool; warnings in advertisements that must be
warning statements on cigar packages Web sites, applications, or other rotated quarterly in alternating sequence
and the quarterly rotation of warning programs that allow for the sharing of in each advertisement for each brand of
statements in cigar advertisements, will audio, video, or photography files; video cigar. Similarly, retailers who are
take effect 12 months after the date of and audio promotions; and items not responsible for or direct their own cigar
publication of this final rule. FDA is subject to the sale or distribution ban in advertising must submit a warning plan
establishing this effective date at 12 § 1140.34. FDA intends to provide for those advertisements.
months before the effective date of the guidance on how to comply with the (Comment 240) One comment
required warnings for cigars described health warning requirements on unique suggested that FDA adopt labeling rules,
under part 1143 (24 months after the types of media. similar to those proposed for premium
publication of the final rule) because the (Comment 238) Several comments cigars, for e-cigarette products that are
Agency anticipates that there will be a noted that the proposed cigar warnings sold without packaging (i.e., require
need for communication with are appropriate for the protection of signage at the point of sale for stores
submitters during its review of the public health. The comments noted that selling e-cigarettes rather than require
warning plan submissions. This the rule would enhance public health by labels on their packages).
submission deadline also helps FDA to extending the labeling requirements (Response) Unlike cigars sold
ensure that its surveillance program for beyond the seven manufacturers individually and not in product
packages, ENDS and any e-liquids the health effects of different types of due to the presence of nicotine, which
containing nicotine that are sold ENDS. is highly addictive and can be absorbed
separately are sold in some sort of As to the comment that e-cigarette into the bloodstream (Ref. 1). Congress
packaging on which the addictiveness warnings should be no larger or more also expressed concern about the
warning can be provided. Therefore, it prominently located than currently addictiveness of these ‘‘inherently
is not necessary at this time to instead required for cigarettes, the final rule dangerous products’’ (section 2(2) of the
require warnings at the point-of-sale. requires the warnings to appear on at Tobacco Control Act). Because the
The warning requirements in this final least 30 percent of the two principal covered tobacco products are made or
rule are appropriate for the protection of display panels of the package, and at derived from tobacco and most (if not
the public health because they provide least 20 percent of the area of all) contain nicotine, they are likely
information to the consumers each time advertisements. These are the same addictive (Refs. 14, 246, 247, 248, 249).
they use the product. warning sizes that Congress established For products that do not contain
for smokeless tobacco in the Tobacco nicotine (i.e., no nicotine at detectable
2. Continuum of Risk Control Act. 15 U.S.C. 4402(a)(2)(A), levels), the rule provides for an
(Comment 241) Several comments (b)(2)(A). In the same Act, Congress alternative warning statement, ‘‘This
asserted that different product prescribed an even larger size for product is made from tobacco.’’
categories should carry different health cigarette warnings: 50 percent on the Consumers, especially youth and
warnings relative to the health risk the front and rear panels of cigarette young adults, wrongly believe that
products present to adult consumers. packaging (and the same 20 percent size many tobacco products covered by this
They also thought that, in view of the for cigarette advertisements) (id. rule are less addictive than cigarettes;
continuum of risk, the size of the § 1333(a)(2), (b)(2)). However, the larger systematically underestimate their
proposed addictiveness warning on e- warning sizes required for cigarettes vulnerability to becoming addicted to
cigarettes and other noncombusted have not yet been implemented because nicotine and the use of tobacco
products is too large and the location the final rule was challenged in court, products; and overestimate their ability
too prominent. For example, one and on August 24, 2012, the United to stop using tobacco products when
comment suggested that FDA require States Court of Appeals for the District they choose (79 FR at 23158–59, 23166).
that this warning be smaller for these of Columbia Circuit vacated the rule and The addictiveness warning will help
products than for smokeless tobacco remanded the matter to the Agency. R.J. consumers understand and appreciate
products (i.e., 20 percent of the Reynolds Tobacco Co., v. Food & Drug the consequences of using tobacco
principal display panel) and it should Administration, 696 F.3d 1205 (D.C. products. The addictiveness warning
appear only on one of the principal Circuit 2012), overruled on other will help ensure that youth and young
display panels of the package. Another grounds by Am. Meat Inst. v. U.S. Dep’t adults, who may be more susceptible to
comment noted that, because of its of Agric., 760 F.3d 18, 25 (D.C. Cir. the addictiveness of nicotine, have a
relative size and placement, the 2014) (en banc). On December 5, 2012, greater awareness of the presence of
proposed e-cigarette warning could the Court denied the government’s nicotine and the addictiveness of these
deter combusted cigarette smokers from petition for panel rehearing and products before they might become
switching to a noncombusted product rehearing en banc, and FDA decided not addicted.
based on a misunderstanding of the to seek further review of the Court’s Additionally, any manufacturer that
relative risks of smoking versus ruling. FDA is conducting research that wishes can submit an MRTP application
electronic and noncombusted products. aims to support a new rulemaking to FDA to show that its product is less
This comment suggested that the consistent with the Tobacco Control Act hazardous than another tobacco
warning on e-cigarettes should be no (see Generic Clearance for the Collection product. When the Tobacco Control Act
larger or more prominently located than of Qualitative Data on Tobacco Products was passed, Congress found that unless
the currently required cigarette and Communications (OMB Control tobacco products that purport to reduce
warnings. Number 0910–0796) and Pretesting of the risks to the public of tobacco use
(Response) FDA disagrees. As Tobacco Communications (OMB Control actually reduce such risks, those
discussed in section VIII, though FDA Number 0910–0674)). For smokeless products can cause substantial harm to
recognizes the existence of a continuum tobacco packaging, the warning labels the public health (section 2(37) of the
of nicotine-delivering products, all must be located on the two principal Tobacco Control Act). Furthermore,
tobacco products are addictive and display panels and cover at least 30 Congress noted that the dangers of
potentially dangerous. There is a public percent of each panel (15 U.S.C. products sold or distributed as MRTPs
health benefit to warning consumers 4402(a)(2)(A)), which is consistent with that do not in fact reduce risk are so
regarding the addictiveness of nicotine, the warning labels required for newly high that FDA must ensure that
regardless of how it is delivered. deemed tobacco products. statements about MRTPs are complete,
Numerous studies show that the (Comment 242) Several comments accurate, and relate to the overall
likelihood that warnings are seen and stated that informing consumers that disease risk of the product (section 2(40)
noticed depends upon their size and tobacco products are addictive by of the Tobacco Control Act).
position. (Refs. 36, 37, 38, 39; see requiring an addictiveness warning does Accordingly, Congress determined that
section II.B.4). In addition, as not fulfill any useful public health goal. manufacturers must demonstrate that
mentioned in section VIII.C, study These comments believed that it is such products meet a series of rigorous
results have been inconclusive about the misleading to describe all nicotine- criteria, and will benefit the health of
effects of ENDS products on the containing products as addictive the population as a whole before they
population. FDA does not believe, at without describing the relative risk of may be marketed to reduce the harm or
this time, that it has sufficient evidence the products. the risk of tobacco-related disease or to
about the risks of ENDS products to (Response) FDA disagrees. The reduce exposures to harmful substances
justify the use of different warnings addictive nature of tobacco products has associated with tobacco products
sizes and to determine the appropriate been well documented. The Surgeon (section 911 of the FD&C Act (21 U.S.C.
size for each product category. FDA will General has long recognized the 387k)). If new research on the relative
continue to monitor research regarding addictive nature of tobacco products risks presented by the use of smokeless
tobacco products and ENDS products § 1140.34. Accordingly, the language of risks of tobacco use and have a number
emerges, FDA may consider proposing §§ 1143.3(b)(2) and 1143.5(b)(2) have of advantages. The frequency of
changes to the warning label been changed to clarify that the exposure is high. In addition, package
requirements. If it does, the Agency will formatting requirements only apply to warnings are delivered both at the time
initiate a new rulemaking in accordance print advertisements and other of tobacco product use and at the point
with the APA. advertisements with a visual of purchase. Thus, the messages are
component. FDA intends to provide delivered to tobacco users at the two
3. Warning Requirements for Other
guidance on how to comply with the most important times—when users are
Media
health warning requirements on unique considering using or purchasing the
(Comment 243) Several comments types of media. tobacco product. The messages on
stated that FDA should clarify the packages also help the public at large,
application of the proposed warnings to 4. Appropriateness of Required
including potential tobacco users, better
television and radio advertisements, as Warnings To Protect Public Health
understand and appreciate the health
well as in catalogs, on Internet sites, and (Comment 244) In response to FDA’s and addictiveness risks of using the
on social media. One comment request in the NPRM, comments products. (See In re Lorillard et al., 80
recommended that advertisers be included data and research regarding FTC 455 (1972); FCLAA; CSTHEA.)
required to include a voiceover stating the effectiveness of health warnings.
the warning out loud, in a clear, They submitted research indicating a 5. Staleness of Warnings
conspicuous, and neutral manner. need for accurate health warnings that (Comment 246) Several comments
Another comment suggested that FDA are large enough to be readable (Refs. 3, noted that requiring only a single health
clarify in the final regulation that 40) and grab the consumer’s attention warning for some newly deemed
§ 1143.3(b) applies only to print (Ref. 40). Comments also submitted tobacco products does not allow for
advertising and not to radio and research indicating that warning labels rotation and the warning will likely
broadcast advertising. influence and increase awareness of the grow stale, resulting in little to no effect
(Response) FDA clarifies that health risks associated with tobacco on consumers. They argued that FDA
§ 1143.3(b)(1) applies to cigarette (Ref. 36, 37, 250) and discourage should require multiple warnings for
tobacco, roll-your-own tobacco, and initiation in nonsmoking youth (Ref. the newly deemed products to allow for
covered tobacco products except for 251). One comment cited other research rotation and to maintain their
cigars as they have their own warning which found that novel information effectiveness. Additionally, comments
requirements as enumerated in presented to smokers was associated urged FDA to revise this warning and
§ 1143.5(b)(1). The FCLAA (15 U.S.C. with greater relevance of the message the other required health warnings as
1331 et seq.), as modified by the Little and motivation to quit (Ref. 252). new evidence emerges on the health
Cigar Act of 1973 (Pub. L. 93–109), (Response) FDA agrees that health risks associated with tobacco products.
makes it unlawful to advertise warnings are an effective means to help (Response) FDA acknowledges that
‘‘cigarettes’’ and ‘‘little cigars’’ on any consumers understand and appreciate the use of a single health warning for
medium of electronic communication the risks of using tobacco products. some newly deemed tobacco products
subject to the jurisdiction of the Federal (Comment 245) Many comments could allow the warning to grow stale
Communications Commission (15 supported the requirement for all over time. While FDA declines to add
U.S.C. 1333). In 1986, Congress enacted tobacco products to contain health additional warnings at this time, FDA
CSTHEA (15 U.S.C. 4401 et seq.), warnings. For example, one comment issued an ANPRM prior to this deeming
extending the broadcast ban to include cited WHO’s 2011 report on the Global rule, seeking comments, data, research,
advertisements for smokeless tobacco Tobacco Epidemic, which states that or other information that may inform
products. effective warning labels increase regulatory actions FDA might take with
FDA further clarifies that the smokers’ awareness of health risks and respect to nicotine exposure warnings.
requirements to include a warning in increase the likelihood they will think FDA also intends to conduct research
§ 1143.3(b)(1) and § 1143.5(b)(1) apply about reducing tobacco consumption and keep abreast of scientific
to all forms of advertising, regardless of and quitting (Ref. 253). The comment developments regarding the efficacy of
the medium in which it appears, for also cited a cohort study of textual the final health warnings and the ways
cigarette tobacco, roll-your-own tobacco, warnings in the United Kingdom, before in which their efficacy could be
and covered tobacco products, and after they were enhanced in 2003 to improved. FDA will use the results of
including cigars. This final rule applies meet the minimum FCTC standard (Ref. this monitoring and research to help
to advertisements appearing in or on, for 37). This study found that, after the determine whether any of the warning
example, promotional materials (point- enhanced warnings were implemented, statements should be revised, or if any
of-sale and non-point-of-sale), UK smokers were more likely to think additional warning statements should
billboards, posters, placards, published about quitting, to think about the health be added, in a future rulemaking.
journals, newspapers, magazines, other risks of smoking, and to be deterred
periodicals, catalogues, leaflets, from having a cigarette compared to 6. Other Format Issues
brochures, direct mail, shelf-talkers, smokers in Australia and the United (Comment 247) There were several
display racks, Internet Web pages, States where smaller warnings did not comments on the general format of the
television, electronic mail conform to FCTC standards. Another health warnings. One comment stated
correspondence, or be communicated comment stated that required warning that the warning provisions should
via mobile telephone, smartphone, statements on packages and require black text on a bright yellow
microblog, social media Web site, or advertisements should provide needed background. According to the comment,
other communication tool; Web sites, information to consumers in a researchers have found that yellow
applications, or other programs that conspicuous and clear manner. seizes attention, is the most noticeable,
allow for the sharing of audio, video, or (Response) FDA agrees. Health is the color the eye perceives fastest,
photography files; video and audio warnings on packages and and universally signals warning or
promotions; and items not subject to the advertisements help consumers to danger (Refs. 254, 255). Another
sale or distribution restriction in understand and appreciate the health comment suggested that the front of the
package should include a short and modification of the format requirements surface, a standard adopted by a number
explicit warning statement that is large is appropriate, we will consider of countries.
enough to be readily visible and changing these requirements in a future (Response) FDA finds that the
readable, and the back of the package rulemaking. required size of the health warnings is
should contain a warning large enough (Comment 248) FDA received a large appropriate for the protection of public
to more fully develop the basis for the number of comments regarding the size health. The IOM, Congress, and Article
front warning statement. The comment of the required health warnings. Several 11 of the FCTC recognize the
noted that the combination of short and comments agreed with the format importance of having the warnings
salient health claims on the front of the requirements proposed in the rule. One cover at least 30 percent of the area of
package with more fully developed comment cited a study concluding that the principal display panels, and users
health information on the back would youth and adults are more likely to are more likely to recall warnings that
produce better consumer awareness and recall larger warnings, rate larger are a larger size and that appear on the
understanding, and greater believability warnings as having greater impact, and front/major surfaces of the tobacco
of the health claim in the mind of the often equate the size of the warning package (Ref. 7). The 30-percent
consumer. Finally, several comments with the magnitude of the risk (Ref. 36). warning label area requirement for
stated that newly deemed products The comment also stated that requiring product packages is also consistent with
should be required to display large health warnings that cover at least 30 the size requirements for similar text-
graphic warnings. percent of the front and back of cigarette only warnings for smokeless tobacco
(Response) FDA declines to make packages is consistent with the FCTC. mandated by Congress in CSTHEA (15
these suggested changes at this time. Several comments argued that the U.S.C. 4402(a)(2)(A)). FDA does not
The format requirements included with required health warnings are too large. believe that the 30-percent warning
this final rule are similar to those One comment stated that if the warnings label area requirement will make
included in a 2001 EU directive, which are too large, they could have the consumers numb to the warning
have been shown to increase the unintended effect of making consumers message. Rather, FDA believes that the
effectiveness of health warnings. EU numb to the warning message or size of the warnings will be effective in
Directive 2001/37/EC requires that otherwise lead to consumers ignoring helping consumers better understand
tobacco warnings in all member the warning. Another comment stated and appreciate the critical information
countries meet certain minimum that the size of FDA’s proposed presented by the health warning.
standards that are similar to those that FDA also believes that the 30-percent
addictiveness warning should be
FDA is finalizing here (i.e., the EU warning label area requirement is
evaluated in the context of the other
required health warnings comprise 30 consistent with the First Amendment
information that already appears on the (as discussed in section II.B). Although
percent of the area on the front of
packaging of noncombusted tobacco the warning will occupy at least 30
package and 40 percent on the back of
products. This comment asserted that percent of the packaging, there will
the package; are in black Helvetica bold
packaging for certain newly deemed remain sufficient space for additional
type on a white background; occupy the
products includes detailed warnings warnings, manufacturer instructions,
greatest possible proportion of the
and other information important to and branding. However, FDA intends to
warning area set aside for the text
reduce risks from inappropriate use or conduct research and keep abreast of
required; and messages are centered in
handling of the product and that such scientific developments regarding the
the warning area and surrounded by a
black border of 3 to 4 millimeters (mm) information may not fit on the package efficacy of the health warnings in the
in width). Before the 2001 Directive, if the proposed health warning occupies final rule and the ways in which their
warnings in most EU countries were 30 percent of the principal display. efficacy could be improved. If FDA
very small and general. In one study Several comments stated that the determines that larger warnings would
conducted for the European proposed warning statement should not be more effective for these newly
Commission, a majority of respondents be required on cigars sold individually deemed products, the Agency will issue
stated that the Directive’s new warning and not in product packages. One cigar a new NPRM in accordance with the
format was more effective and more retailer stated that requiring warnings APA.
credible than the previous format (Ref. on 30 percent of the principal display (Comment 249) Comments stated that
256). A study of Spanish university panels would be excessive. The FDA should not require manufacturers
students also concluded that text comment believed that a health warning to use a font size that occupies the
warnings based on the Directive covering 30 percent of each cigar box greatest possible proportion of the
significantly increased perceptions of would be excessive when there are warning area because that would leave
the risk of tobacco products (Ref. 257). multiple boxes, particularly when limited, if any, white space and may
Additionally, studies showed that the combined with the requirement for a prove to be illegible. These comments
requirement that the warnings appear in warning sign at the point of sale. suggested that FDA reduce the font size
black text on a white background or Another comment asserted that the size requirement to be consistent with
white text on a black background of the proposed health warnings would smokeless tobacco warnings, which are
improved the legibility and noticeability be inconsistent with the First required to take up 60 to 70 percent of
of the warnings (Refs. 7, 38). Amendment. the warning area.
FDA believes that the prescribed Other comments argued that FDA (Response) FDA disagrees. Newly
format of the health warnings will be should require larger health warnings. deemed tobacco products are sold in a
effective in helping consumers better One comment stated that numerous variety of packaging sizes. By requiring
understand and appreciate the risks of studies show that youth and adults are the font size to be at least 12-point font,
these products. However, FDA intends more likely to recall larger warning FDA is ensuring that the required
to conduct research and keep abreast of messages and rate larger messages as warning statement will be noticed by
scientific developments regarding the having a greater impact (Ref. 37). consumers regardless of the package
efficacy of the final health warnings and Another comment stated that the FCTC size. Further, FDA believes that this
the ways in which their efficacy could suggests that warnings should cover 50 requirement will leave adequate
be improved. If FDA determines that percent or more of a pack’s principal background space so that the warning is
legible. The format requirements are (Response) FDA disagrees. Both 7. Waterpipe Tobacco
similar to those included in a 2001 EU Helvetica and Arial fonts are included (Comment 253) One comment argued
directive (requiring warnings to occupy in common printing software. Thus, the that the required warning should not be
the greatest possible portion of the requirement that manufacturers use applied to hookah (or waterpipe
warning area set aside for the required Helvetica or Arial font should not cause tobacco) because there is a lack of
text), which have been shown to them to incur any additional costs. substantial scientific evidence of the
increase the effectiveness of health However, we also have included addictiveness of this product. The
warnings, as further discussed in this language throughout part 1143, which comment expressed the belief that the
section of the document. FDA is not allows manufacturers to use other majority of waterpipe tobacco smokers
aware of any legibility issues with the similar sans serif fonts in order to in the United States use the product
EU health warnings and does not expect provide additional flexibility while still once a week or less. Another comment
any legibility issues with the health ensuring that the warnings are asserted that studies of noncigarette
warnings included in this final rule. conspicuous and legible to consumers. products, including waterpipe tobacco,
The size of the warning clearly
(Comment 252) Many comments show that these products are perceived
matters, as recall increases significantly
argued for different formatting to present less risk of harm and
with font size (Ref. 258). In a study on
requirements for the health warnings. addictiveness, thereby encouraging use
recall of health warnings in smokeless
Some suggested that they should be among young adults. The comment
tobacco ads, conducted with 895 young
males, 63 percent of participants consistent with the current FTC Consent added that strong warnings regarding
recalled a high contrast warning in 10- Decree, which requires that health the addictiveness of all tobacco
point font; doubling the font size for the warnings be clear and conspicuous in products may reduce trial and use in
warning to a 20-point font increased relation to the other communications on vulnerable populations (Ref. 259).
(Response) FDA disagrees that the
recall from 63 percent to 76 percent the packaging and be presented in a
addictiveness warning should not be
representing a 20 percent improvement black box format to attract consumer
applied to waterpipe tobacco. Waterpipe
in recall (id.). Research on cigarette attention. One comment stated that FDA
package warnings confirms that larger tobacco contains nicotine, which is the
should accept alternative warning sizes,
warnings are better noticed and more primary addictive chemical in tobacco
placements, and font sizes for different products. Researchers have observed
likely to be recalled (Ref. 7 at App. C– packaging sizes and configurations, as
3; Refs. 38, 49). These studies support nicotine dependence characteristics in
long as the warning is clear and some users (Refs. 238, 239, 240), with
FDA’s conclusion that requiring the conspicuous. This comment urged FDA
proposed warnings to appear in at least one study showing that waterpipe
to be flexible about the size and tobacco use suppressed withdrawal
12-point font size will improve their placement of the warnings on deemed
noticeability. symptoms just as cigarette smoking
products, some of which are offered in suppresses withdrawal symptoms (Ref.
(Comment 250) At least one comment packaging sizes and configurations very
believed that requiring warnings to 240). Because waterpipe smoking
different from cigarette and smokeless sessions last longer than smoking a
occupy at least 20 percent of the area of
tobacco packaging. This comment also cigarette and there is increased smoke
an advertisement would result in
noted that it can be difficult to identify volume, a single session of waterpipe
warning statements that, while visible,
the two principal display panels. smoking (which typically lasts 20 to 80
are more likely to be ignored. This
comment suggested that appropriate (Response) FDA disagrees. FDA has minutes) likely exposes users to more
warning statements be presented in a concluded that the formatting nicotine than smoking a cigarette
minimum font size (e.g., no smaller than requirements for the health warnings, (which typically takes 5 to 7 minutes).
11-point type). which are similar to the requirements Indeed, a meta-analysis of studies
(Response) FDA is unaware of any for smokeless products and similar to regarding waterpipe use showed that a
evidence stating that a health warning those suggested by FCTC, are single episode of waterpipe use is
occupying at least 20 percent of the area appropriate for the protection of the associated with exposure to 1.7 times
of an advertisement is likely to be public health. In addition, we have the nicotine in a single cigarette.
ignored. Nevertheless, to ensure that the added language to this final rule which FDA agrees that there is consumer
statements are visible and effectively recognizes that if a product package is confusion about the addictiveness of
conveying information, FDA is too small to bear the required warning waterpipe tobacco. Whereas studies
finalizing §§ 1143.3(b)(2)(ii) and statement, the manufacturer of the have shown that cigarette and waterpipe
1143.5(b)(2)(ii) to require a minimum product can include the warning tobacco smoking deliver similar
12-point font size for the health statement on the outer carton or on a nicotine levels, one study showed that
warnings on advertisements. Moreover, hang tag attached to the product 46.3 percent of high school students
the requirement that the warning package. wrongly believed that waterpipe tobacco
statement occupy at least 20 percent of is less addictive or less harmful than
the area of the advertisement is the same To clarify how to determine the cigarettes, and one-third of these
as the statutory requirement for press principal display panels, FDA is students wrongly believed that the
and poster advertisements for smokeless defining ‘‘principal display panels’’ of a product had less nicotine, no nicotine,
tobacco products (section 3(b)(2)(B) of product package as the panels of a or was generally less addictive than
CSTHEA (15 U.S.C. 4402(b)(2)(B))). package that are most likely to be cigarettes (Ref. 260). Mistaken beliefs
(Comment 251) At least one comment displayed, presented, shown or that waterpipe tobacco smoking is ‘‘safer
expressed concern with the font examined by the consumer. In addition, or less addictive than cigarettes’’ were
requirements of the labeling provisions the principal display panels should be more prevalent among those who had
because they require businesses to large enough to accommodate all ever used waterpipe tobacco (78.2
purchase a software package that mandatory label information in a clear percent) compared to nonusers (31.6
provides either or both of the prescribed and conspicuous manner. The principal percent) (Ref. 260). A study of nearly
fonts (Helvetica and Arial), and these display panels may be on an outer 2,000 university students found that
are proprietary fonts. carton for small vials holding e-liquids. waterpipe tobacco was considered by
those students to be less addictive than warning requirements in CSTHEA (as are sold and in a way that is clearly
e-cigarettes, marijuana, cigar products, amended by the Tobacco Control Act) as visible to potential purchasers.
smokeless tobacco, and cigarettes (Ref. ‘‘any tobacco product that consists of (Response) FDA understands these
261). Research found that college cut, ground, powdered, or leaf tobacco concerns. However, for those cigars sold
students who had used waterpipes and that is intended to be placed in the individually and not in a product
within the past 30 days considered them oral or nasal cavity.’’ Some dissolvable package, the placement of warnings at
less addictive and less harmful than tobacco products do not meet the the point of sale will be adequate to
never-users did (Ref. 26). Similarly, definition of ‘‘smokeless tobacco disseminate the required health
another study found that ‘‘[freshmen product’’ because they do not contain information and is appropriate for the
college] students who used waterpipes cut, ground, powdered, or leaf tobacco; protection of the public health. For
and cigars perceived them as less instead, these products contain nicotine cigars that are sold in cellophane
harmful than regular cigarettes’’ (Ref. extracted from tobacco. These products wrappers, these wrappers are
262). Moreover, research has shown that are the dissolvable products covered by considered packaging and, under this
such false beliefs about product risks this final rule. Because they do not meet final rule, must include the required
can be a significant predictor of the statutory definition of a smokeless cigar warnings. In addition, FDA notes
subsequent use behavior (Refs. 263, tobacco product, FDA cannot recognize that youth attempting to purchase these
264). For instance, adolescents with the them as such, as suggested by the cigars would be prohibited from doing
lowest perceptions of short-term risks comments. If FDA determines that the so under the minimum age requirements
related to smoking were 2.68 times more warning statements for any type of included in this final rule.
likely to initiate smoking (Ref. 264). We dissolvable product should be revised, (Comment 258) One comment
note that the Surgeon General’s 2014 or if any additional warning statements expressed concern that the NPRM did
Report provides an objective discussion should be added to them, the Agency not provide for warnings where
of nicotine and addiction, where will initiate a new rulemaking in premium cigars and cigars sold
‘‘nicotine addiction develops as a accordance with APA requirements. individually and without product
neurobiologic adaptation to chronic packaging are sold online. The comment
(Comment 256) One comment stated
nicotine exposure. However, all forms of suggested that these cigars should either
that the use of an addictiveness warning
nicotine delivery do not pose an equal not be allowed to be sold individually
would serve to protect the public health
risk in establishing or maintaining or that individual cigars should be
by more clearly identifying dissolvable
nicotine addiction’’ (Ref. 9 at 112). required to be packaged and include a
products as addictive tobacco products
Thus, pattern of use is a factor in the warning label.
and differentiating them from candy. (Response) Under the Internal
facilitation of addiction.
(Comment 254) One comment stated (Response) FDA agrees. Certain Revenue Code and TTB regulations,
that FDA should require the tobacco products have a candy-like cigars that are taxpaid upon removal
addictiveness warning on all appearance, frequently are sold next to from the factory or release from customs
components of waterpipe tobacco use, candy, and are packaged in a way that custody must be in the packages in
including those products without makes them more attractive to children, which they will be delivered to the
nicotine or tobacco. which can mislead consumers to think ultimate consumer (bearing any marks
(Response) FDA disagrees. FDA finds that they are, in fact, candy (Refs. 54, or notices required by the Internal
that requiring health warnings on 215). The addictiveness warning will Revenue Code and TTB regulations) at
covered tobacco products only (and not clearly identify these products as the time of removal, and must remain in
on the components and parts that are tobacco products and help differentiate those consumer packages until taken
not made or derived from tobacco) is them from candy. from the package by the consumer or in
appropriate to protect the public health, 9. Premium Cigars and Unpackaged the presence of the consumer. Removing
because youth and young adults will not Cigars taxpaid cigars from the package, other
be able to use such components and than in the presence of the waiting
parts, and potentially suffer the (Comment 257) Several comments consumer, is a violation of the Internal
consequences of tobacco use, without stated that not requiring warnings on Revenue Code. Cigars may nonetheless
also using the covered tobacco product. premium cigars and those sold be sold individually, provided that the
In the event that FDA later determines individually and without product individual product packaging meets the
it is appropriate for the protection of the packages would greatly diminish the requirements of the IRC and TTB
public health to extend the warning effectiveness of the cigar warnings. One regulations. An online retailer sending
requirements to components and parts comment stated there are many such individual cigars purchased online
that are not made or derived from instances where cigars are purchased as can comply with FDA’s requirements by
tobacco, the Agency will initiate a new gifts and, in those instances, the placing the warning statement on the
rulemaking in accordance with APA recipients would not see these box or container that is used to ship the
requirements. warnings. One comment also stated that product. In addition, FDA clarifies that
if a purchaser receives with the the warning requirements apply to all
8. Dissolvable Products premium cigar any wrapper, container, forms of advertising, regardless of the
(Comment 255) One comment pack or bag, then FDA should require medium in which they appear. As stated
suggested that FDA recognize all that it include a health warning. This previously, advertisements subject to
dissolvable tobacco products as would ensure that if the premium cigar this final rule may appear in or on, for
smokeless tobacco products for the is given for a celebratory occasion, or if example, promotional materials (point-
purpose of warning label regulation and, a minor obtained a premium cigar from of-sale and non-point-of-sale),
as a result, subject all dissolvables to the an adult and did not see the point-of- billboards, posters, placards, published
smokeless warning requirements in sale warning, the user would be warned journals, newspapers, magazines, other
section 204 of the Tobacco Control Act. of the health risks. Another comment periodicals, catalogues, leaflets,
(Response) ‘‘Smokeless tobacco stated that the warning labels should be brochures, direct mail, shelf-talkers,
product’’ is defined in section 900(18) of permanently affixed to or inside the display racks, Internet Web pages,
the FD&C Act and for purposes of the cellophane wrappers in which the cigars television, electronic mail
correspondence, or be communicated appropriate for the protection of public FDA mandates for cigarettes in the
via mobile telephone, smartphone, health. FDA notes that the requirement future.
microblog, social media Web site, or only applies where cigars are sold (Response) FDA disagrees. Cigarette
other communication tool; Web sites, individually and unpackaged, and will tobacco and roll-your-own tobacco do
applications, or other programs that ensure that consumers of these products not meet the definition of the term
allow for the sharing of audio, video, or are exposed to the same health warnings ‘‘cigarette’’ in section 3(1) of FCLAA.
photography files; video and audio as consumers of other cigar products. Because cigarette tobacco and roll-your-
promotions; and items subject to the FDA also believes the point-of-sale own tobacco are not cigarettes as
sale or distribution restriction in warnings are necessary to prevent defined by FCLAA, they do not need to
§ 1140.34. As stated in § 1143.5(b)(2), manufacturers and retailers of cigars comply with section 4 of FCLAA
the formatting requirements only apply from circumventing the warning requiring cigarette warnings and,
to advertisements with a visual requirement by selling their products therefore, do not contain any warning to
component. FDA intends to provide without packaging. alert consumers of the health effects of
guidance on how to comply with the Moreover, the United States v. Philip these products. Instead, the Tobacco
health warning requirements on unique Morris holding cited in the comment Control Act defines cigarette tobacco
types of media. was not on the merits and in any event and roll-your-own tobacco in sections
(Comment 259) One comment stated is not applicable here. That case 900(4) and 900(15) of the FD&C Act,
that premium cigars sold individually involved corrective statements respectively. The lack of a warning on
should include a health warning on the mandated in a civil Racketeer these tobacco products may lead
cigar tube, if applicable, or FDA should Influenced and Corrupt Organizations consumers to believe that they are safe
require retailers to provide a paper Act (RICO) case brought against the products. Therefore, with this final rule,
warning to the purchaser or put cigars United States’ major cigarette FDA is requiring that manufacturers of
in bags that are pre-printed with the companies. After finding the defendants such products comply with the
warning labels. liable for racketeering and fraud, the addiction warning in § 1143.3 and any
(Response) It is unclear exactly how lower court issued an injunction that other future health warnings that FDA
this comment intends to affix the required the defendants to disseminate mandates for these products, where
warning to the premium cigar. If this public statements in order to prevent appropriate.
comment is referring to affixing a and restrain future fraud. The (Comment 262) Some comments
warning to the cigar tube, this may statements were required to appear in expressed concern about the following
damage the cigar and, therefore, is various types of media—including large- warning as applied to pipe tobacco
impractical. If this comment is seeking point-of-sale signs present at the products: ‘‘WARNING: This product
to add the warning to the tube that checkout counter of retailers that contains nicotine derived from tobacco.
packages some individual cigars, FDA participated in defendants’ Nicotine is an addictive chemical.’’
does not believe this is appropriate. ‘‘participating retailer’’ programs. On They stated that this warning is not
Cigars sold individually in product appeal, noting that the retailers were not appropriate for these products because
packages, including cigars sold in tubes, involved in the RICO litigation but were the first sentence of the warning
must comply with the warning negatively affected by the injunctive suggests that it is targeted at e-cigarettes
statement requirements for packaging. remedy, and had not had the whose nicotine is derived from tobacco,
For cigars sold individually and not in opportunity to present arguments not tobacco itself. Other comments
product packages, the required warning against the point-of-sale location before expressed concern that the word
statements must instead be posted at the the lower court ruled, the appellate ‘‘derived’’ would not be well
retailer’s point of sale. FDA believes that court vacated the point-of-sale understood by the majority of
the point of sale signage requirement requirement on due process grounds, consumers and introduced unnecessary
will ensure that premium cigar and remanded for further consideration complexity. They also noted that the
purchasers, as well as purchasers of by the lower court. Philip Morris USA statement that the nicotine is derived
other individual cigars, receive the Inc., 566 F.3d at 1141–42. The appellate from tobacco does not provide
required health warnings while court did not rule on whether information that is relevant to the user’s
allowing persons selling or distributing mandatory point-of-sale corrective health. One comment suggested a
the cigars to maintain existing business statements in valuable retail space are number of changes to the proposed
practices. permissible under the RICO statute, but addiction warning, including a simpler
(Comment 260) One comment simply ruled that before the district alternative: ‘‘WARNING: This product
expressed concern about retailers court could impose such a requirement, contains nicotine. Nicotine is an
having to forfeit counter space for the the RICO statute required ‘‘considering addictive chemical.’’
placement of health warnings for cigars the rights of third parties and existing (Response) FDA agrees with concerns
sold individually and not in product contracts’’ (id. at 1145). By contrast, using the word ‘‘derived.’’ FDA has
packages. The comment stated that this these warning requirements are being concluded that the suggested warning
space is reserved for some of the most issued under the Tobacco Control Act, statement ‘‘WARNING: This product
profitable items for sale in convenience not the RICO statute; and are the contains nicotine. Nicotine is an
stores. The comment also stated that the product of notice-and-comment addictive chemical’’ is a more
U.S. Circuit Court of Appeals for the rulemaking. appropriate warning label because it
District of Columbia struck down a provides an accurate warning for both
similar, judicially imposed warning 10. Cigarettes and Roll-Your-Own products that contain leaf tobacco and
requirement that required retailers to set (Comment 261) Some comments products that contain nicotine derived
aside valuable retail space to display a stated that FDA should conform the from tobacco. It is also clearer and does
point-of-sale sign. (United States v. proposed health warnings for cigarette not introduce unnecessarily complex
Philip Morris USA Inc., 566 F.3d 1095 tobacco and roll-your-own tobacco to terms that may make it more difficult for
(D.C. Cir. 2009).) the federally mandated health warnings consumers to understand and appreciate
(Response) FDA believes that the for cigarettes required by section 4(s) of the risks of addiction. Similarly, FDA is
point-of-sale warnings are necessary and FCLAA and to health warnings that revising the alternative statement to
read ‘‘This product is made from cigars can become addicted to cigars statement does not use the term
tobacco.’’ to remove use of the word given the absorption of nicotine. ‘‘tobacco product’’ and does not state
‘‘derived,’’ which may not be easily Accordingly, FDA finds that it is that any ENDS product contains
understood. However, FDA disagrees appropriate for the protection of the tobacco. Instead, the alternative
with comments stating that this warning public health to require this warning on statement included with this final rule
should not be required on pipe tobacco all cigars. states: ‘‘This product is made from
packages because pipe tobacco contains tobacco.’’
12. Alternative Statement/Certification
nicotine, which is the primary addictive
for Products Without Nicotine: ‘‘This FDA is not aware of any currently
constituent in tobacco products.
Thus, FDA has changed § 1143.3(a)(1) Product Is Derived From Tobacco.’’ marketed tobacco product that does not
to require that for cigarette tobacco, roll- (Comment 265) Several comments contain nicotine. If such a product is
your-own tobacco, and covered tobacco expressed concern about requiring a introduced in the future, FDA believes
products other than cigars, it is tobacco product that does not contain it is important that both consumers and
unlawful for any person to manufacture, nicotine to have an alternate health retailers be alerted that, although it may
package, sell, offer to sell, distribute, or warning stating that, ‘‘this product is not contain nicotine, it is nevertheless a
import for sale or distribution within derived from tobacco.’’ These comments tobacco product. From a public health
the United States such product unless stated that future products that are not perspective, FDA believes that it is
the tobacco product bears the following derived from tobacco would fall outside important to convey this factual
required warning statement on each of FDA’s jurisdiction and, therefore, information to consumers because
product package label: ‘‘WARNING: would not be required to include this tobacco products (i.e., products made or
This product contains nicotine. Nicotine statement on product packages. derived from tobacco) could contain
is an addictive chemical.’’ (Response) FDA agrees. If a product is
other addictive chemicals (like
not made or derived from tobacco, it
11. Addictiveness Warning would not be required to bear the anabasine or nornicotine) and/or
(Comment 263) One comment stated alternative statement. However, if a dangerous toxicants and can be
that the need to inform consumers about product is made or derived from tobacco psychologically addictive as well. For
the addictiveness of nicotine has been but does not contain nicotine, the example, users of de-nicotinized
implicitly recognized by a number of product is required to bear the cigarettes consistently report a
manufacturers of e-cigarette products. alternative statement. As discussed in significant degree of subjective
The comment stated that a recent section XVI.B, FDA is revising this satisfaction (Refs. 265, 266, 267). The
investigation by the staff of 11 U.S. alternative statement to read ‘‘This alternative warning statement is
Senators and Representatives of the product is made from tobacco.’’ especially important in light of the
practices of 9 of the largest e-cigarette (Comment 266) Several comments recent proliferation of novel tobacco
manufacturers revealed that, although stated that FDA should not permit use products (e.g., dissolvables that may
their product warning labels ‘‘lack of the alternate statement ‘‘This product appear like candy) that do not resemble
uniformity and may confuse is derived from tobacco’’ because there traditional tobacco products, and
consumers,’’ 6 of the 9 companies are studies showing instances of e- therefore, which consumers may not
included some form of nicotine warning cigarette products being labeled as zero know are made from tobacco. As the
as part of their packaging or instructions nicotine and actually containing comments noted, some consumers are
for use, in addition to the nicotine nicotine (Refs. 20, 170). not even aware that e-cigarettes are
warning these companies included to (Response) FDA disagrees. If a tobacco
tobacco products.
satisfy California’s Proposition 65 (see product manufacturer has mislabeled its
Ref. 31). Although the warnings are not product to indicate that it does not FDA believes that the fact that a
as comprehensive as FDA’s required contain nicotine when in fact it actually product without nicotine is made from
health warnings in terms of size and does, the manufacturer will be subject to tobacco is important factual information
prominence, they reflect the companies’ enforcement action for misbranding and that should be conveyed to both
own recognition that their products are the product will be required to bear the consumers and retailers. In addition to
addictive and that consumers should be addictiveness warning (instead of the providing consumers with significant
informed of their addictive properties. alternative statement). information that could affect their
(Response) Requiring health warnings (Comment 267) A few comments health, the statement will help ensure
on all newly deemed tobacco products suggested that the alternative warning that retailers are aware that the product
will help consumers better understand statement will cause consumer is and must be treated as a tobacco
and appreciate the addictive properties confusion because most people believe product. This will result in increased
of these products. nicotine causes cancer and the retailer compliance with the minimum
(Comment 264) Some comments alternative statement suggests there is a age and photo identification
questioned whether large cigars, difference in the health risks based on requirements, as well as other
particularly premium cigars, should be solely the presence of nicotine. Other applicable requirements. FDA believes
required to carry an addiction warning comments stated that the alternative
that this factual alternative statement is
because users do not inhale the cigar statement should not use the term
the simplest, least burdensome, and yet
smoke. ‘‘tobacco product’’ because e-cigarettes
(Response) Regardless of whether effective way to inform both consumers
do not contain tobacco leaf. These
cigar smokers inhale, they are still comments also stated that the words and retailers that, despite the absence of
subject to the addictive effects through ‘‘tobacco product’’ could also nicotine, the product is still a tobacco
nicotine absorption (Refs. 32, 34). Cigar potentially cause confusion because product that, like other tobacco
smoke dissolves in saliva, allowing the consumers do not consider e-cigarettes products, may not be purchased by or
smoker to absorb sufficient nicotine to to be tobacco products. sold to persons under the age of 18 and
create dependence, even if the smoke is (Response) FDA disagrees that the requires the presentation and
not inhaled (Refs. 34, 35). Therefore, language in the alternative statement examination of a photo identification
consumers using premium or other will cause confusion. The alternative card.
13. Warning: Cigars Are Not a Safe than cigarette smoke, the science clearly contain higher levels of certain
Alternative to Cigarettes supports the proposed warning. nitrosamines in sidestream smoke than
However, several other comments do filtered tip cigarettes (Ref. 69 at 81).
(Comment 268) A few comments stated that the scientific evidence does The Surgeon General has reiterated
noted that evidence indicates there is a not support the claim that ‘‘secondhand that there is considerable evidence that
widespread perception, particularly smoke causes premature death and certain nitrosamines are major factors in
among young people, that cigars are less disease in youth and in adults who do the development of lung cancer (Ref.
hazardous than cigarettes and this not smoke.’’ One of these comments 272 at 30). According to the Surgeon
perception may be contributing to the stated that the epidemiological links General, the evidence is sufficient to
increased incidence of cigar smoking. between ‘‘being married to a smoker’’ infer a causal relationship between
According to the comments, one study and increased disease are tenuous at secondhand smoke exposure and lung
found that adult cigar smokers in best. While these comments agreed that cancer among lifetime nonsmokers (Ref.
general are three times more likely to on a per-stick basis, cigars can produce 272 at 434). Individuals living with
believe cigars are a safe alternative to larger amounts of environmental smokers have a 20 to 30 percent
cigarettes compared to those who do not tobacco smoke than do cigarettes, they increase in risk of developing lung
smoke cigars (Ref. 268). They also cited stated that it is not accurate to conclude cancer from secondhand exposure (id. at
an online survey of college students at that this exposes household members to 445). Although data particular to cigars
six colleges in the southeastern United a considerable involuntary health risk. are not available, FDA believes it is
States, which found that smokers of (Response) FDA agrees with the reasonable to expect that cigar smoke
little cigars and cigarillos ‘‘were more comments stating that this warning is would produce similar effects as
likely to report perceiving the harm of appropriate for the protection of the cigarette smoke, given that data from the
little cigars, cigarillos, and cigars to be public health. It is well established that National Cancer Institute (NCI) cigar
less than that of cigarettes’’ when secondhand smoke causes premature monograph shows that some
compared to nonusers (Ref. 269). In death and disease in youth and in adults carcinogens determined to cause lung
addition, a study of middle school and who do not smoke (Ref. 272 at 445, 532). cancer are present at higher levels in
high school students in Massachusetts Adult exposure to secondhand smoke cigar smoke than in cigarette smoke and
found that 34.9 percent of current youth has immediate adverse effects on the are present at levels comparable to other
cigar users agreed that ‘‘cigars are not as cardiovascular system and causes lung carcinogens linked to lung cancer (Ref.
bad for you as cigarettes,’’ while only cancer and coronary heart disease (id.). 69 at 76–93).
12.2 percent of the total study Tobacco smoke contains over 7,000 There is also a causal relationship
population of students agreed with the compounds, and there are more than 70 between secondhand smoke and heart
statement (Ref. 270). The comments also carcinogens in sidestream and disease. The health warning statement
cited a similar study that included a mainstream smoke generated from indicating that tobacco smoke can cause
focus group study of 230 middle school, cigars (Refs. 9, 70, 273). Mainstream heart disease is thoroughly supported by
high school, and college students, cigar smoke is the smoke that one draws the evidence reiterated in reports from
which found that 30 percent of teen into his or her mouth from the butt end the Surgeon General. FDA believes it is
cigar users made the statement that, or mouthpiece of a cigar; whereas reasonable to conclude that this finding
compared to cigarettes, cigars are less sidestream cigar smoke is the smoke would produce similar effects with
risky, and only 10 percent of teens with emitted from the burning cone of a cigar respect to secondhand cigar smoke
no cigar experience made that statement during the interval between puffs (Ref. exposure based on the similar smoke
(Ref. 271). 69 at 65). Cigar smoke ‘‘tar’’ appears to profiles for cigars and cigarettes, the risk
be at least as carcinogenic as cigarette of coronary heart disease associated
(Response) FDA agrees that there is an smoke ‘‘tar’’ (Ref. 272). The Surgeon with active cigar smoking, and the low
unsubstantiated perception, especially General recently reiterated that cigar levels of toxicant exposure that can
among young people, that cigars are less smoke contains the same toxic cause coronary heart disease (Ref. 272).
hazardous than cigarettes (see 79 FR at substances as cigarette smoke, with In a 2006 Surgeon General’s report
23158). This warning requirement will varying concentrations of these regarding the health effects of exposure
help to consumers understand and constituents found in different types to secondhand smoke, the evidence
appreciate the risks of cigars. and sizes of cigars (Ref. 69 at 17–18; Ref. demonstrated that exposure of adults to
14. Warning: Tobacco Smoke Increases 272 at 362). secondhand smoke had immediate
the Risk of Lung Cancer and Heart There is a causal relationship between adverse effects on the cardiovascular
Disease, Even in Nonsmokers lung cancer and secondhand smoke. system and caused coronary heart
Exposure of nonsmokers to secondhand disease (id. at 11). Secondhand smoke
(Comment 269) The comments smoke also has been shown to cause a increased the risk of coronary heart
differed as to whether the warning significant increase in urinary levels of disease nearly as much as active heavy
‘‘Tobacco Smoke Increases the Risk of metabolites of tobacco-specific smoking. In fact, the estimated increase
Lung Cancer and Heart Disease, Even in nitrosamines, a carcinogen that in risk of coronary heart disease from
Nonsmokers’’ was appropriate. Some specifically links exposure to exposure to secondhand smoke was 25
comments thought that the health secondhand smoke with an increased to 30 percent above that of unexposed
warning was appropriate. At least one risk for lung cancer (Ref. 69 at 65). All persons (id. at 519; Ref. 273 at 532).
noted that a causal relationship exists cigars produce higher levels of Based on these data, the Surgeon
between secondhand smoke exposure carcinogenic tobacco-specific General concluded that ‘‘the evidence is
and lung cancer among lifetime nitrosamines per gram in mainstream sufficient to infer a causal relationship
nonsmokers, and individuals living cigar smoke than cigarettes produce in between exposure to secondhand smoke
with smokers had a 20 to 30 percent mainstream cigarette smoke (id. at 75– and increased risks of coronary heart
increase in the risk of developing lung 76). Cigar smoke also produces disease morbidity and mortality among
cancer from secondhand exposure (Ref. measurable amounts of lead and both men and women’’ (Ref. 272 at 15).
272 at 445). They stated that, since all cadmium (id. at 75–76). Little cigars The IOM agreed, concluding that there
cigars produce higher levels of toxicants with filter tips and regular cigars is a causal relationship between
secondhand smoke exposure and 16. Reproductive Health Warning for evidence supports that women who
cardiovascular disease, as well as a Cigars smoke have an increased risk of
causal relationship between secondhand In the proposed deeming rule, FDA infertility and stillbirth (Ref. 276). It also
smoke exposure and acute myocardial proposed to require four of the five causes an increased risk of sudden
infarction (Ref. 275 at 219). warnings already included on most infant death syndrome (SIDS) for infants
Even a relatively brief exposure to cigar packages and in most cigar whose mothers smoke during and after
secondhand tobacco smoke can lead to pregnancy (Ref. 275 at pp. 587 and 601).
advertisements as a result of settlement
heart disease, as some studies have In addition, scientific evidence supports
agreements between the FTC and the
demonstrated. The IOM found there is the conclusion that cigar smoke has
seven largest U.S. cigar manufacturers.
compelling circumstantial evidence that similarly toxic effects. NCI’s Monograph
(See, e.g., In re Swisher International,
a relatively brief exposure to 9 states:
Inc., Docket No. C–3964.) FDA proposed
secondhand smoke can bring about an
not to require the fifth warning there is no reason to expect that cigar smoke
acute coronary event (id. at 220). would be any less toxic for the mother or
Given that the effects of secondhand (SURGEON GENERAL WARNING:
Tobacco Use Increases the Risk of fetus. Regular cigar smoking, particularly
smoke on coronary heart disease are with inhalation, should be presumed to have
linked to the combustion of tobacco Infertility, Stillbirth and Low Birth
risks similar to that of cigarette smoking for
itself, FDA concludes that exposure to Weight) because although cigarette
the pregnant smoker.
secondhand cigar smoke can cause the smoke causes these health effects (and
cigar smoke is similar to cigarette (Ref. 69 at 10). On balance, FDA prefers
same or similarly dangerous effects as
smoke), the Agency stated it was not a warning that is specific to cigars, so
exposure to secondhand cigarette
aware of studies specifically linking FDA is finalizing this rule with different
smoke. Thus, FDA believes the warning
statement that ‘‘Tobacco smoke cigars to all three reproductive effects. warning language specifically relating to
increases the risk of lung cancer and FDA requested comment on its proposal cigars that the Agency concludes is
heart disease, even in nonsmokers’’ is to require the use of only four of the five appropriate for the protection of the
appropriate for the protection of the current FTC warnings for cigars. public health. However, given the
public health. During the comment period, FDA accuracy of the original FTC warning on
received several comments encouraging its face, given that cigar smoke contains
15. Warning: Cigar Smoking Can Cause FDA to reconsider its proposal and and delivers the same harmful
Cancers of the Mouth and Throat, Even finalize the rule to include all five constituents as cigarette smoke, and
if You Do Not Inhale warnings. In response to these given extensive evidence that cigar
(Comment 270) Several comments comments, FDA reconsidered whether smoke has similar physiological effects
disagreed with FDA’s rationale for the to require use of the FTC reproductive on the body, it is also appropriate for
warning ‘‘Cigar smoking can cause health warning. While FDA agrees that the protection of the public health for
cancers of the mouth and throat, even if FTC’s general warning statement FDA to allow the use of the optional
you do not inhale.’’ These comments ‘‘Tobacco Use Increases the Risk of alternative (SURGEON GENERAL
noted that the rationale depends almost Infertility, Stillbirth and Low Birth WARNING: Tobacco Use Increases the
exclusively on Monograph 9 from the Weight’’ is a factually correct statement Risk of Infertility, Stillbirth and Low
National Cancer Institute, which did not and recognizes that cigar smoke is Birth Weight) to the reproductive health
distinguish among cigar types and, similar to cigarette smoke in both warning.
therefore, should not be required for chemical content and effects, on FDA selected the new warning
premium cigars. They also stated that balance, FDA prefers a warning that is language for several reasons. First, FDA
cigars are safe products if users do not specific to cigars. Therefore, FDA has finds that this warning is supported by
inhale the smoke, as illustrated by reconsidered the issue and is including direct scientific evidence that nicotine
experimental data showing minimal a fifth warning statement to read adversely affects maternal and fetal
toxicity because cigar smokers do not ‘‘WARNING: Cigar Use While Pregnant health (Ref. 9). Second, this warning
inhale (Refs. 32, 74). Can Harm You and Your Baby.’’ which uses the term ‘‘cigar use’’ rather than
(Response) FDA disagrees. The fact is well supported by direct evidence ‘‘tobacco use,’’ because the warning
that Monograph 9 did not distinguish and is appropriate for the protection of would appear on cigars only. Third,
among types of cigars does not mean the public health. However, FDA is also FDA finds that this is powerful and
that it only applies to certain cigar allowing manufacturers to use the FTC comprehensible phrasing, which will be
types. In fact, the statement in the warning, which is appropriate for the understandable to a wide audience.
Monograph applied to all types of protection of the public health, as an Nevertheless, FDA recognizes that many
cigars. Any cigar use exposes the mouth optional alternative to the new cigar manufacturers currently use FTC’s
and throat to tobacco smoke and can reproductive health warning. truthful warning on the reproductive
cause several different types of cancer The FTC warning is about tobacco risks of tobacco smoke. Therefore, FDA
even without inhalation (Refs. 69, 104). smoke generally, and the statement is also allowing an optional alternative
For example, one study found an itself is well supported by scientific (SURGEON GENERAL WARNING:
increased risk of head and neck cancers evidence. Researchers have confirmed Tobacco Use Increases the Risk of
for those who do not smoke cigarettes that smoking causes negative effects on Infertility, Stillbirth and Low Birth
but had previously smoked cigars (Ref. fertility, pregnancies, and infants and Weight) to the reproductive health
104). children born to women who smoke. warning to comply with the warning
While inhaling cigar smoke poses For example, cigarette smoking requirements for cigars. FDA expects
higher risk rates than not inhaling, increases rates of preterm delivery, that allowing the optional alternative
significant risk still exists for those who shortened gestation, and orofacial clefts, will benefit entities bound by the FTC
do not inhale. In addition, most cigar and studies have indicated that women consent decrees.
smokers do inhale some amount of who smoke are twice as likely to have (Comment 271) Comments from cigar
smoke and are not aware that they are low birth weight infants as women who makers contended that because the
doing it, including those who do not do not smoke (Ref. 9 at p. 499; Ref. 275 NPRM and the FTC consent orders both
intend to inhale (Ref. 33). at pp. 569, 576). In addition, scientific required five warnings, but not the same
five warnings, manufacturers would not without the warning, could result in warning statements for cigar packages
be able to use one set of warnings to claims that the FTC consent orders have must be carried out in accordance with
comply with both regimes. As one been violated. The comment requested a warning plan submitted by the cigar
comment put it, ‘‘For example, that FDA ensure that the absence of manufacturer, importer, distributor, or
manufacturers could not ensure a such warning in any final rule will not retailer to, and approved by FDA.
random display of FDA’s five warnings result in a claim that the FTC consent FDA is also requiring that the
‘in as equal a number of times as is orders have been violated. required warning statements be rotated
possible,’ as required by the NPRM, (Response) In the NPRM, FDA quarterly in alternating sequence in
while including the reproductive effects indicated that it planned to consult with each advertisement for each brand of
warning required by FTC in that random FTC ‘‘to harmonize national cigar, regardless of whether the cigar is
distribution.’’ This comment went on to requirements for health warnings on sold in product packaging. This rotation
state that a reproductive warning for cigar product packages and in of warning statements in cigar
cigars is also required by California’s advertisements’’ (79 FR 23142 at 23163). advertisements also must be done in
Proposition 65, and added that in As noted previously, FDA has given accordance with a warning plan
response to an inquiry from FTC at the careful consideration to the comments submitted to FDA by the cigar
time of the FTC consent orders, the and the scientific evidence on this issue manufacturer, importer, distributor, or
California Attorney General agreed that and has decided to require a retailer to, and approved by FDA. As
‘‘compliance with the FTC Consent reproductive health warning for cigars, stated in § 1143.5(c)(3) of this final rule,
Order will result in compliance with and the Agency has discussed this each person required to randomly
Proposition 65.’’ (Comments of Altria evidence and decision with FTC. At this display and distribute or rotate
Client Services Inc. on behalf of John time, FDA is not aware of any concerns warnings in accordance with an FDA-
Middleton Co., FDA–2014–N–0189– from FTC regarding the cigar warnings approved plan under this part must
79814.) included with this final rule. submit a proposed warning plan to FDA
Other comments urged that there is no later than either 12 months after
17. Rotation of Warnings on
scientific support to require a [date of publication of final rule], or 12
Advertisements
reproductive warning for cigars. For months before advertising or
example, one comment asserted that (Comment 273) Several comments commercially marketing a product that
this warning is based on data related to stated that rotational warning is subject to such requirement,
cigarette smoke, and given that cigarette requirements should be simple, whichever is later. This 12-month
smoke is very similar to cigar smoke, streamlined, and easily administrated, submission timeframe provides cigar
and in many cases, cigar smoke is more especially for small businesses. One entities time to develop and submit
dangerous than cigarette smoke, it is a comment suggested that it should be warning plans to FDA. FDA encourages
logical conclusion that this warning is sufficient to print equal numbers of firms to submit warning plans any time
appropriate for cigars. Another labels containing all six warnings and within this 12-month period, and FDA
comment noted that the 2014 U.S. rely on the randomness of market plans to begin reviewing warning plans
Surgeon General Report on tobacco use distribution patterns without the as soon as they are received. FDA is
devotes an entire chapter to the health administrative burden of demonstrating establishing this effective date at 12
effects of nicotine and documents that to FDA in a written rotational plan, and months before the effective date of the
nicotine crosses the placenta and in subsequent facility inspections, that required warnings for cigars described
concentrates in the fetus (Ref. 9). The FDA can determine that each different under part 1143 (24 months after the
comment also noted that nicotine warning was equally displayed to each publication of the final rule) because the
constricts vessels and thus limits the consumer for each brand during a 12- Agency anticipates that there will be a
amount of nutrients and oxygen month period. need for communication with
delivered to the fetus. (Response) While FDA recognizes that submitters during its review of the
(Response) While FDA is unaware of the random display and distribution of warning plan submissions. This
data directly and explicitly linking cigar warning statements on cigar product submission effective date also helps
smoke to such reproductive issues, FDA packages and the rotation of statements FDA to ensure that its surveillance
recognizes the similarities between on advertisements can result in program for compliance with the
cigarette smoke and cigar smoke. On administrative and financial costs for warning label requirements under
balance, FDA prefers a warning specific cigar manufacturers, FDA does not § 1143 is implemented as of the effective
to cigars. However, as noted previously, believe it would be sufficient to rely on date of 24 months after the publication
FDA is allowing an optional alternative the randomness of market distribution of the final rule.
(SURGEON GENERAL WARNING: patterns. Relying on random FDA intends to work with
Tobacco Use Increases the Risk of distribution would not ensure that the manufacturers, importers, distributors,
Infertility, Stillbirth and Low Birth different health warning messages are or retailers to get an approved warning
Weight) to the reproductive health reaching as many individuals as plan in place. Cigar entities may wish to
warning to comply with the warning possible, and the health warnings may contact FDA to discuss the submission
requirements for cigars. FDA expects grow stale from overuse if repeated too of their warning plans in order to make
that allowing the optional alternative many times for the same individual. the approval process more orderly and
will benefit entities bound by the FTC Thus, FDA is requiring warning efficient. FDA’s review and approval of
consent decrees. statements for cigar packages to be a warning plan enables the Agency to
(Comment 272) One comment randomly displayed in each 12-month more effectively conduct surveillance
expressed concern that the exclusion of period in as equal a number of times as and inspection activities to ensure
the reproductive effects warning in a possible on each brand of cigar. The compliance with the warning label
final rule (i.e., the FTC warning that required warning statements also are requirements under § 1143, once
states ‘‘Tobacco Use Increases The Risk required to be randomly distributed in effective, by providing a guide regarding
Of Infertility, Stillbirth And Low Birth all areas of the United States in which the expected rotation of the various
Weight’’), and the subsequent the product is marketed. The random warnings as required by the regulation.
advertising and sale of cigar packages display and distribution of required In addition, the review and approval
process will help manufacturers, warning statement can be removed, then health risks and hazards listed in this
importers, distributors, and retailers it is not permanent and does not meet comment and will be focusing efforts
understand the requirements under this the requirements of § 1143.9. Removable and resources on future efforts to
part; and help cigar entities minimize or impermanent warnings on packages prevent nicotine poisoning in both users
potential economic loss from the and in advertisements could become and nonusers. Therefore, FDA issued an
commercial distribution of separated from the package or ANPRM prior to this deeming rule,
nonconforming products in the market. advertisement and thus would not meet seeking comments, data, research, or
Additionally, FDA believes that it will the requirement that they be other information that may inform
be able to complete its review of the conspicuous on the package or regulatory actions FDA might take with
submitted warning plans by the advertisement. Removable warnings respect to nicotine exposure warnings
effective date of the required cigar would run counter to FDA’s purpose of and the use of child-resistant packaging.
warnings. In FDA’s experience with the effectively conveying risk information to In addition, elsewhere in this issue of
review of warning plans for smokeless consumers. the Federal Register, FDA has made
tobacco products, no smokeless tobacco available draft guidance for public
product manufacturer, importer, 18. Warnings for E-Liquids
comment, which when final will
distributor, or retailer was delayed or (Comment 275) Several comments represent FDA’s current thinking
prevented from advertising or recommended that FDA require regarding some appropriate means of
distributing smokeless tobacco products multiple and rotating warnings on all e- addressing the premarket authorization
due to FDA’s review of its warning plan, liquids that contain nicotine. They requirements for newly deemed ENDS
and FDA does not anticipate a different stated the potential consequences of products, including recommendations
outcome here. FDA intends to issue a nicotine use need to be listed explicitly, for exposure warnings and child-
guidance document within 12 months as explicit warnings are associated with resistant packaging that would help to
after publication of the final rule to greater perception of potential danger support a showing that the marketing of
assist the cigar industry with the than vague or general warnings (Ref. a product is appropriate for the
requirements for the submission of 277). Suggestions for e-cigarette warning protection of public health.
warning plans. In addition, if FDA label content included: (1) Toxicity and (Comment 276) Several comments
receives a higher volume of warning potential lethality of nicotine; (2) danger noted that FDA should establish
plans than anticipated, and determines to skin and eyes; (3) danger from alternative methods for providing health
that it will not be able to review and ingestion of nicotine liquids; (4) other warnings on tobacco products with
approve submitted warning plans by the potential health hazards, including small packages, such as e-cigarettes.
24-month effective date, FDA may also burns and explosions, from ENDS use; One comment noted that FDA has
consider implementing a compliance (5) keep out of reach of children; (6) created special rules for small food
policy to ensure that cigar entities are information about the heating packages and small over-the-counter
not delayed or prevented from mechanism (coil) and energy source drug packages where the size of the
advertising or distributing cigars due to (battery); (7) information about package prevents the manufacturer from
FDA’s review of their warning plans. overheating or overuse, including risk of satisfying certain mandatory labeling
These requirements are consistent fire (if applicable); (8) warnings or requirements. This comment suggested
with those established by Congress in precautions about use in or near water that FDA implement similar alternatives
the Tobacco Control Act for currently as well as any electrical shocks; and (9) for displaying warnings on small e-
regulated tobacco products. Section 3 of warnings and instructions about cigarette packages, and that the warning
CSTHEA (as amended by section 204 of replacing components and parts. on advertising materials should not
the Tobacco Control Act) requires the Another comment believed the exceed 10 percent of the area of the
random distribution and rotation of Agency should consider requiring advertisement. Another comment
warnings for smokeless tobacco manufacturers of e-cigarettes to provide asserted that many e-liquids are
products. Further, rotation of cigar additional information for consumers in packaged in relatively small 10 milliliter
warning statements already occurs e-cigarette packaging, and as vials and that FDA should consider
under the FTC consent decrees. The appropriate, for other newly deemed package size and design when
WHO also has recognized the need to tobacco products. The comment mandating health warnings.
rotate health warnings for tobacco suggested that this information could be (Response) To address the issue of
products. The WHO’s FCTC, evidence of presented using communication tobacco products with small packages,
a strong worldwide consensus regarding principles similar to those used in we have added § 1143.3(d) to this final
a regulatory strategy for addressing the ‘‘Drug Facts’’ for over-the-counter drugs rule, which states that a tobacco product
serious negative impacts of tobacco and should include information such as that would otherwise be required to bear
products, calls for warnings that are the nicotine addiction warning, age the warning in § 1143.3(a)(1) but is too
‘‘rotating’’ and ‘‘large, clear, visible and limits, warnings about danger to small or otherwise unable to
legible’’ (WHO FCTC article 11.1(b)). children and pets, and information accommodate a label with sufficient
(Comment 274) One comment stated about use during pregnancy and breast space to bear the information is exempt
that the proposed requirement that the feeding. from compliance with the requirement
warning statements be permanent or (Response) At this time, FDA finds it provided the information and
irremovable is ambiguous and does not is appropriate for the protection of the specifications required under
specifically address whether labels public health to require the warning § 1143.3(a)(1) and (a)(2) appear on the
applied by manufacturers (which regarding the addictiveness of nicotine carton or other outer container or
manufacturers intend not to be removed on ENDS. However, as we have stated wrapper if the carton, outer container,
but technically are removable) are previously, this deeming regulation is a or wrapper has sufficient space to bear
compliant with the rule. foundational rule, affording the Agency such information, or appears on a tag
(Response) Section 1143.9 requires the ability to publish additional otherwise permanently affixed to the
that the health warnings be indelibly regulations as necessary and appropriate tobacco product package. In these cases,
printed on or permanently affixed to for the protection of the public health. the carton, outer container, wrapper, or
packages and advertisements. If a FDA remains concerned about all of the tag will serve as the location of the
principal display panels. For example, these requirements with the preparation This final rule would result in a 1-year
FDA is aware that e-liquids are of a proposed environmental assessment expenditure that meets or exceeds this
frequently sold in small vials that may and a final environmental assessment amount.
be unable to accommodate a label with (Ref. 278). This final rule finalizes Option 1 of
sufficient space to bear a health (Comment 278) One comment the NPRM, which deems all products
warning. In addition, small boxes of requested that FDA issue a new meeting the statutory definition of
replacement cartridges will be required Environmental Assessment due to ‘‘the ‘‘tobacco product,’’ except accessories of
to carry a warning if they contain loss of irreplaceable cultural historical a newly deemed tobacco product, to be
nicotine or tobacco, or are otherwise resources that directly relate to the subject to chapter IX of the FD&C Act.
made or derived from tobacco, and, heritage of the [Ybor City National This final rule also finalizes additional
therefore, are covered tobacco products. Historic Landmark] District, the City of provisions that would apply to certain
Such products also may not have Tampa, the State of Florida[, and] the newly deemed products as well as to
sufficient space to bear a health United States of America.’’ certain other tobacco products. Once
warning. In these cases, a manufacturer (Response) FDA denies this request. deemed, tobacco products become
could include such information on the FDA prepared its Environmental subject to the FD&C Act and its
carton or other outer container or Assessment in accordance with the implementing regulations. The FD&C
wrapper if the carton, outer container, requirements of 21 CFR part 25. FDA Act requirements that will apply to
or wrapper has sufficient space to bear properly accounted for all potential newly deemed products include
the information, or appear on a tag that environmental consequences of that establishment registration and product
is permanently affixed to the tobacco action on the quality of the human listing, ingredient listing, submissions
product package. With respect to the environment. Therefore, a new prior to the introduction of new
part of this comment stating that health Environmental Assessment is products, and labeling requirements.
warnings on advertising materials unnecessary and contrary to the Free samples of newly deemed tobacco
should not exceed 10 percent of the area requirements of NEPA (Ref. 279). products will also be prohibited. The
of the advertisement, see the NPRM (79 XVIII. Analysis of Impacts additional provisions of this final rule
FR 23142 at 23164) for additional include minimum age and identification
discussion regarding the need for We have examined the impacts of the requirements, vending machine
prominent health warnings. final rule under Executive Order 12866, restrictions, and required warning
Executive Order 13563, the Regulatory statements for packages and
XVII. National Environmental Policy Flexibility Act (5 U.S.C. 601–612), and advertisements.
Act the Unfunded Mandates Reform Act of While FDA currently has authority to
The Agency has carefully considered 1995 (Public Law 104–4). Executive regulate cigarettes, cigarette tobacco,
the potential environmental effects of Orders 12866 and 13563 direct us to roll-your-own tobacco, and smokeless
deeming products to be subject to the assess all costs and benefits of available tobacco under chapter IX of the FD&C
FD&C Act and the age and identification regulatory alternatives and, when Act, under the final rule, all additional
restrictions. FDA has concluded that the regulation is necessary, to select tobacco products that meet the statutory
actions will not have a significant regulatory approaches that maximize definition, except accessories of those
impact on the human environment, and net benefits (including potential newly deemed tobacco products, will be
that an environmental impact statement economic, environmental, public health subject to chapter IX of the FD&C Act
is not required. The Agency’s finding of and safety, and other advantages; and its implementing regulations.16
no significant impact and the evidence distributive impacts; and equity). We These products include cigars, pipe
supporting that finding, contained in an have developed a comprehensive tobacco, waterpipe tobacco, ENDS
environmental assessment, may be seen Economic Analysis of Impacts that (including e-cigarettes), and other novel
in the Division of Dockets Management assesses the impacts of the final rule. tobacco products such as certain
(see ADDRESSES) between 9 a.m. and 4 We believe that this final rule is a dissolvable products and gels. These
p.m., Monday through Friday. significant regulatory action as defined products further include components
FDA’s responses to comments by Executive Order 12866. and parts of the newly deemed
regarding the proposed Environmental The Regulatory Flexibility Act products, including pipes, e-liquids,
Assessment are included in the requires us to analyze regulatory options atomizers, batteries, cartomizers
following paragraphs. that would minimize any significant (atomizer plus replaceable fluid-filled
(Comment 277) One comment stated impact of a rule on small entities. We cartridge), tank systems, flavors for e-
that FDA erroneously relied upon the find that the final rule will have a liquids, vials that contain e-liquids,
environmental impact analyses required significant economic impact on a programmable software, flavor
by the National Environmental Policy substantial number of small entities. enhancers for waterpipe tobacco,
Act (NEPA), suggesting that the Agency The Unfunded Mandates Reform Act waterpipe cooling attachments, water
should review and analyze the total of 1995 (section 202(a)) requires us to
environmental impact of the rule. prepare a written statement, which 16 As stated in section 201(rr) of the Federal Food,
(Response) FDA disagrees. The includes an assessment of anticipated Drug, and Cosmetic Act in relevant part, a tobacco
product: (1) Means any product made or derived
analysis of a regulation’s environmental costs and benefits, before issuing ‘‘any from tobacco that is intended for human
impact is governed by NEPA, which rule that includes any Federal mandate consumption, including any component, part, or
requires FDA to assess, as an integral that may result in the expenditure by accessory of a tobacco product (except for raw
part of its decisionmaking process, the State, local, and tribal governments, in materials other than tobacco used in manufacturing
a component, part, or accessory of a tobacco
environmental impacts of any proposed the aggregate, or by the private sector, of product); and (2) Does not mean an article that is
Federal action to ascertain the $100,000,000 or more (adjusted a drug under section 201(g)(1) of the Federal Food,
environmental consequences of that annually for inflation) in any one year.’’ Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), a
action on the quality of the human The current threshold after adjustment device under section 201(h) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(h)), or a
environment and to ensure that the for inflation is $144 million, using the combination product described in section 503(g) of
interested and affected public is most current (2014) Implicit Price the Federal Food, Drug, and Cosmetic Act (21
appropriately informed. FDA satisfied Deflator for the Gross Domestic Product. U.S.C. 353(g)).
filtration base additives, flavored and we cannot predict the size of these There will be potential costs for
waterpipe tobacco charcoals, and benefits at this time. Among other removing non-compliant point-of-sale
waterpipe bowls, valves, hoses, and effects, new products will be subject to advertising and complying with vending
heads. an evaluation to ensure they meet the machine restrictions.
The final deeming action differs from appropriate public health standard for The primary estimate for the present
most public health regulations in that it the pathway before they can be value of total quantified costs over 20
is an enabling regulation. In addition to marketed, labeling cannot contain
directly applying the substantive years is approximately $988 million at
misleading statements, and FDA will be
requirements of chapter IX of the FD&C a 3 percent discount rate and $817
made aware of the ingredients in newly
Act and its implementing regulations to million at a 7 percent discount rate. The
deemed tobacco products. If, without
newly deemed tobacco products, it the final rule, new products would pose quantified costs of the final rule can also
enables FDA to issue further regulations substantially greater health risks than be expressed as annualized values, as
related to such products that are those already on the market, the shown in table 1. Unquantified costs
appropriate for the protection of the premarket requirements made effective which may be attributable to this final
public health. We expect that asserting by this final rule would keep such rule include: Some consumer costs for
our authority over these tobacco products from appearing on the market users of the newly deemed products due
products will enable us to propose and worsening the health effects of to loss of product variety or higher
further regulatory action in the future as tobacco product use. The warning prices; recordkeeping costs for exporters
appropriate, and those actions will have statements required by this final rule of deemed tobacco products;
their own costs and benefits. Without will help consumers better understand compliance costs for components and
deeming these products to be subject to and appreciate the risks and parts other than complete pipes,
the FD&C Act, FDA would lack the characteristics of tobacco products. waterpipes, and ENDS delivery systems;
authority to require manufacturers to The final rule as a whole will impose the cost of testing and reporting for
provide, for example, vital ingredient costs in the form of registration, HPHCs; the cost of any clinical testing
and health information about them. We submission, and labeling requirements. that may potentially be conducted to
would also lack the authority to take Manufacturers of newly deemed support SE reports; market adjustment
regulatory action with respect to them, products, as well as some manufacturers (friction) costs and lost producer
if we determined it was appropriate to of currently regulated products, will surplus associated with product
do so. need to comply with the warning label consolidation, exit of manufacturers,
The direct benefits of making each of provisions, which will impose and the switch to pure retailing among
the newly deemed tobacco products additional costs, including costs for retailers such as vape shops who
subject to the requirements of chapter IX signs with warnings at point-of-sale for currently engage in manufacturing
of the FD&C Act are difficult to quantify, cigars sold singly without packaging. activities.
TABLE 5—SUMMARY OF QUANTIFIED COSTS OVER 20 YEARS ($ MILLION)

Lower bound Primary Upper bound Lower bound Primary Upper bound
(3%) (3%) (3%) (7%) (7%) (7%)
Present Value of Private Sector Costs .... 517.7 783.7 1,109.8 450.4 670.9 939.8
Present Value of Government Costs 1 ..... 204.6 204.6 204.6 145.7 145.7 145.7
Present Value of Total Costs ................... 722.3 988.2 1,314.4 596.1 816.5 1,085.4
Annualized Value of Private Sector Costs 34.8 52.7 74.6 42.5 63.3 88.7
Annualized Value of Government Costs 1 13.8 13.8 13.8 13.8 13.8 13.8
Annualized Value of Total Costs ............. 48.5 66.4 88.3 56.3 77.1 102.5
1 FDA costs represent an opportunity cost, but this rule will not result in changes to overall FDA accounting costs, the size of the federal budg-
et, or the total amount of tobacco industry user fees.
Because it is not possible to compare periods of time during which FDA does the sake of simplicity only, we have
benefits and costs directly when the not intend to enforce certain referred to these four approaches as
benefits are not quantified, we employ requirements). First, we assess the ‘‘alternatives to the rule.’’
a breakeven approach. For the reasons regulatory alternative of exempting In addition to the above alternatives,
provided elsewhere in this preamble premium cigars from regulation. comments discussed changing the
and in the analysis of impacts, FDA has Second, we assess two hybrid regulatory grandfather date as an alternative. FDA
concluded that the benefits of the final alternatives/enforcement options of has decided not to include this option
rule justify the costs. providing either a 36-month or 12- in the analysis of alternatives because
In addition to the benefits and costs month compliance period for labeling we determined that the Agency lacks
of this final rule, we assess the benefits changes. Lastly, we assess the the authority to change the grandfather
and costs of four different approaches. enforcement option of not extending the date.
These approaches consist of regulatory premarket review compliance policy to Primary estimates of the costs of the
alternatives (i.e., alternatives to the rule) new flavored tobacco products (other regulatory alternatives appear as present
as well as enforcement options (i.e., than tobacco flavored products).17 For values and annualized values in table 6.
17 Throughout the final RIA, any reference to
‘‘flavored tobacco products’’ means flavored

products other than tobacco flavor.
TABLE 6—PRIMARY ESTIMATE OF QUANTIFIED COSTS FOR REGULATORY ALTERNATIVES (PRESENT AND ANNUALIZED
VALUES, $ MILLION) 1
Annualized Annualized
Present value Present value
Alternative value value
(3%) (7%) (3%) (7%)
1—Exempt Premium Cigars from Regulation ................................................. 959 794 64 75

2a—36-month compliance period for labeling changes .................................. 968 797 65 75
Final Rule and Compliance Period .................................................................. 988 817 66 77
2b—12-month compliance period for labeling changes .................................. 1,043 871 70 82
3—Do not extend the premarket review compliance policy to new flavored
tobacco products .......................................................................................... 1,141 961 77 91
1 Nonquantified benefits are described in the text.
In addition to the social costs will likely do so. Regulatory alternatives 1, all products meeting the definition of
described in this document, the final that would reduce costs are analyzed as a ‘‘tobacco product,’’ except accessories
rule would lead to distributional effects, potential regulatory relief options for of newly deemed tobacco products,
such as: Reduced revenues for firms in small businesses. would be deemed. Option 2 was the
affected sectors, payment of user fees, The Economic Analysis of Impacts of same as Option 1, except a subset of
and potential changes in tax revenues. the final rule performed in accordance cigars known as ‘‘premium cigars’’
Domestic tobacco product with Executive Order 12866, Executive would be excluded. After thorough
manufacturers, tobacco product Order 13563, the Regulatory Flexibility review of the comments and the
importers, and vape shops are the Act, and the Unfunded Mandates scientific evidence, FDA has concluded
businesses primarily affected by this Reform Act is available at http:// that Option 1 more effectively protects
rule; most of these businesses are small. www.regulations.gov under the docket the public health and therefore has
We focus the quantitative analysis of number(s) for this final rule (Ref. 204) made that the scope of the final rule.)
small entities on manufacturers and and at http://www.fda.gov/AboutFDA/ The rule also prohibits the sale of
importers of cigars and ENDS products. ReportsManualsForms/Reports/ covered tobacco products to individuals
We note that most pipe tobacco and EconomicAnalyses/default.htm. under the age of 18 and prohibits the
waterpipe tobacco manufacturers and sale of covered tobacco products using
XIX. Paperwork Reduction Act of 1995
importers are also small, and we expect the assistance of any retail-based
the impact on them to be similar to the This final rule contains information electronic or mechanical device (such as
impact on cigar manufacturers and collection provisions that are subject to a vending machine) except in facilities
importers. Even though user fees are a review by the Office of Management and where the retailer ensures that no
transfer payment and not a societal cost, Budget (OMB) under the Paperwork person younger than 18 years of age is
they are a cost from the standpoint of Reduction Act of 1995 (PRA) (44 U.S.C. present, or permitted to enter, at any
the cigar and pipe manufacturers who 3501–3520). The title, description, and time. The requirement that a retailer sell
must pay them under this final rule and respondent description of the covered tobacco products in only a
have been included in the estimated information collection provisions are direct, face-to-face exchange without the
burden for cigar manufacturers and shown in the following paragraphs with assistance of electronic or mechanical
importers. Estimated costs per cigar an estimate of the annual reporting and devices is not intended to prevent the
manufacturer or importer are $278,000 recordkeeping burden. Included in the sale of tobacco products via the Internet,
to $397,000 in the first year, $292,000 to estimate is the time for reviewing but the sale of covered tobacco products
$411,000 in the second year, and instructions, searching existing data via any medium (including the Internet)
$235,000 to $257,000 in the third year. sources, gathering and maintaining the must only be to persons 18 years of age
(The inclusion of user fees in these data needed, and completing and or older.
estimates will cause costs to be reviewing each collection of The rule also provides that
overstated for manufactures and information. manufacturers, distributors, importers,
importers who also manufacture Title: Deeming Tobacco Products To and retailers are responsible for
currently regulated products. In Be Subject to the Federal Food, Drug, ensuring that the covered tobacco
addition, costs will vary by firm size as and Cosmetic Act, as Amended by the products (in addition to cigarettes and
user fees are based on market share). Family Smoking Prevention and smokeless tobacco) they manufacture,
Estimated costs per ENDS manufacturer Tobacco Control Act; Restrictions on the label, advertise, package, distribute,
or importer are $827,000 to $1.21 Sale and Distribution of Tobacco import, sell, or otherwise hold for sale
million in the first year, $832,000 to Products and Required Warning comply with all applicable
$1.21 million in the second year, and Statements for Tobacco Products. requirements.
$22,000 to $64,000 in subsequent years. Description: On June 22, 2009, the In addition, elsewhere in this issue of
Although we do not quantitatively President signed the Tobacco Control the Federal Register, FDA has made
examine the financial effects on vape Act into law. In this rule, the Agency is available a final guidance to provide
shops, we expect the proportion of vape extending FDA’s ‘‘tobacco product’’ information on how to establish and
shops that mix e-liquids may fall during authorities in the FD&C Act to all other reference a Tobacco Product Master File
the initial compliance policy period for categories of products meeting the (TPMF). TPMFs are expected to reduce
submission and FDA receipt of PMTAs. statutory definition of ‘‘tobacco the burden on applicants preparing
After this initial compliance policy product’’ in section 201(rr) of the FD&C premarket and other regulatory
period, we expect that most vape shops Act, excluding accessories of deemed submissions because they can reference
will continue to operate but those that tobacco products. (Two options were information in TPMFs rather than
have not already switched pure retailing presented in the NPRM. Under Option develop the information on their own.
Currently, FDA does allow for the asked that FDA not stifle manufacturers, offering them targeted
submission and use of information to be advertisements, nor saddle the industry relief in certain areas to address
incorporated by reference similar to with unnecessary testing and reporting concerns that small manufacturers may
master file programs for other FDA- standards that stifle innovation and need additional time to comply with
regulated products. increase costs. certain requirements of the FD&C Act,
(Response) FDA disagrees with as discussed in section IV.D. This
A. Responses to Comments Regarding comments suggesting that FDA’s rule compliance policy will provide small-
Proposed Collection of Information will have such effects on industry or the scale tobacco product manufacturers
1. Whether the Proposed Collection of nation. FDA finds that deeming tobacco (i.e., those manufacturers with 150
Information Is Necessary for the Proper products and applying the automatic employees or fewer and $5,000,000 or
Performance of FDA’s Functions, provisions of the FD&C Act in less in annual revenues) with additional
Including Whether the Information Will accordance with this final rule will time to submit ingredient listing
Have Practical Utility result in significant public health information (under section 904(a)(1))
benefits and that the additional and health documents (under section
(Comment 279) We received several
restrictions imposed by this rule are 904(a)(4)). This policy also provides
comments regarding the practical utility appropriate for the protection of the that, for the first 30 months following
of the information to be collected by public health. For example, benefits that the effective date of the rule, small-scale
FDA under the proposed regulations. will arise as a result of deeming ENDS, tobacco product manufacturers may
The main concern among comments including FDA review of premarket receive extensions of time for providing
was that some of the requirements submissions/applications for new responses to SE deficiency letters.
impose significant administrative tobacco products in the United States (Comment 282) Several comments
burdens without generating useful pursuant to sections 905 and 910 of the stated that the PMTA process imposes a
information. Also, the comments FD&C Act, which will result in number of burdens on manufacturers,
believed that FDA is predicting that the increased product consistency. FDA the most onerous burden being the
paperwork burden will force almost all expects to receive premarket requirement for scientific investigations.
of the e-cigarette products to come off submissions/applications from ENDS (Response) In the NPRM (79 FR 23142
the market because manufacturers will manufacturers that will allow the at 23176), FDA included discussion
go out of business. Agency to determine whether a new intended to supplement and clarify the
(Response) FDA’s regulation of the product is substantially equivalent to a requirement for scientific investigations.
newly deemed products and the valid predicate product, exempt from As we noted, FDA expects that, in some
information the Agency is seeking will SE., or appropriate for the protection of cases, it will be possible for an applicant
benefit the public health. As FDA the public health. to obtain a PMTA marketing order
discussed in the NPRM, deeming all without conducting new nonclinical or
tobacco products to be subject to 2. Accuracy of FDA’s Estimate of the clinical studies where there is an
chapter IX of the FD&C Act will provide Burden of the Proposed Collection of established body of evidence regarding
FDA with critical information regarding Information, Including the Validity of the public health impact of the product.
the health risks of the products. FDA the Methodology and Assumptions Therefore, FDA believes that certain
has not received any data indicating that Used categories of PMTAs may not require
regulation ‘‘will destroy almost all of the (Comment 281) Many comments significant financial and administrative
e-cigarette products on the market.’’ We argued that their products could be resources associated with clinical
also note that FDA is announcing a driven from the market due to the investigations. Elsewhere in this issue of
compliance policy for small-scale paperwork reporting requirements and the Federal Register, FDA is
tobacco product manufacturers, offering FDA’s authorization process. The announcing the availability of a draft
them targeted relief to address concerns comments claimed that many guidance, which when final will
that small manufacturers may need companies (particularly e-cigarette provide the Agency’s current thinking
additional time to comply with certain companies) lack experience or the regarding some appropriate means of
requirements of the deeming rule, as systems in place to comply with the addressing the premarket authorization
discussed in section IV.D. This NPRM and that the premarket requirements for newly deemed ENDS
compliance policy will provide small- requirements would discourage the products, including the need for
scale tobacco product manufacturers development of new products. They ‘‘clinical studies’’ for the purposes of
(i.e., those manufacturers with 150 also said that requirements like labeling preparing PMTAs for ENDS. In addition,
employees or fewer and $5,000,000 or and registration would be unfeasible for elsewhere in this issue of the Federal
less in annual revenues) with additional small producers lacking the experience Register, FDA has made available a final
time to submit ingredient listing of navigating this regulatory guidance to provide information on how
information (under section 904(a)(1)) environment. to establish and reference a Tobacco
and health documents (under section (Response) FDA expects that the Product Master File. TPMFs are
904(a)(4)). This policy also provides greater regulatory certainty created by expected to reduce the burden on
that, for the first 30 months following the premarket review process will help applicants preparing premarket and
the effective date of the rule, small-scale companies to invest in creating novel other regulatory submissions.
tobacco product manufacturers may products that benefit the health of the We also note that FDA is announcing
receive extensions of time for providing population as a whole, with greater an enforcement policy for small-scale
responses to SE deficiency letters. confidence that the improved products tobacco product manufacturers, offering
(Comment 280) One comment stated in which they have invested will enter them targeted relief in certain areas to
that FDA’s proposed regulation is the market without having to compete address concerns that smaller
unnecessary and does not address any against equally novel products that do manufacturers may have, as discussed
valid need in society. It also stated that not have to meet the same basic in section IV.D. This compliance policy
the PRA should set limits on regulations requirements. We also note that FDA is will provide small-scale tobacco
that do not provide significant return to announcing a compliance policy for product manufacturers (i.e., those
the U.S. population. Another comment small-scale tobacco product manufacturers with 150 employees or
fewer and $5,000,000 or less in annual meet the requirements for SE exemption manufacturers and 14 importers of
revenues) with additional time to under section 905(j)(3) and does not ENDS products.
submit ingredient listing information have an appropriate predicate under (Comment 286) Many comments said
(under section 904(a)(1)) and health section 905(j)(1)(A)(i) or is otherwise that FDA’s estimates of the burdens
documents (under section 904(a)(4)). unable make a showing supporting a imposed by the rule’s information
This policy also provides that, for the finding of SE., the manufacturer of the collection requirements are understated.
first 30 months following the effective new product must submit a PMTA. As Specifically, they stated that the
date of the rule, small-scale tobacco FDA stated in the NPRM, the Agency Agency’s estimates of the number of
product manufacturers may receive expects that some applicants may not respondents in the category of ‘‘other
extensions of time for providing need to engage in resource-intensive tobacco, e-cigarettes, and nicotine
responses to SE deficiency letters. clinical investigations and provide long- product manufacturers,’’ as well as the
(Comment 283) Several comments term data to prepare and submit a number of products on the market
expressed concern that FDA failed to complete PMTA. In addition, elsewhere manufactured by these companies, were
provide any data on the number or type in this issue of the Federal Register, off by orders of magnitude.
of e-cigarette businesses currently FDA has made available draft guidance, (Response) Based on the comments
operating in the United States. which when final will describe FDA’s and other evidence, FDA estimates there
According to the comments, there are at current thinking regarding some will be 186 manufacturers of ENDS
least 1,250 businesses. Other comments appropriate means of addressing the products. Regarding the number of
estimated that there are 14,000 to 16,000 premarket authorization requirements products, the number will depend on
e-cigarette retail outlets in the United for newly deemed ENDS products, what type of submission is being sent to
States. They stated that these small including the need for clinical studies FDA. The burden charts in this section
manufacturing entities will not be able for the purposes of preparing PMTAs for detail the current estimates FDA
to participate in the PMTA process and ENDS. believes to be accurate.
most will go out of business. (Comment 285) Several comments (Comment 287) Some comments
(Response) At the time of the NPRM, argued that FDA has greatly indicated that FDA equates the time and
FDA did not have precise estimates for underestimated the total number of e- financial burden of preparing a PMTA
ENDS products. Now that we have more liquid products that are on the market. with an SE application, but the PMTA
data, the Agency is estimating the According to one comment, there are requirements are significantly more
numbers for ENDS liquids and delivery nearly 1,700 e-cigarette and e-liquid burdensome than SE requirements, and
systems elsewhere in the PRA section. businesses on record, which does not it is completely unreasonable to allocate
As stated previously, FDA believes the include the many companies that the same amount of man-hours needed
TPMF process will help companies as manufacture hardware components to successfully complete a PMTA and
they can reference information in used in ARPVs. One comment stated an SE application.
TPMFs rather than develop the that a recent study found that greater (Response) The Agency has revised
information on their own. Additionally, than 34,000 different e-liquid products the estimated burden per PMTA
the enforcement policy for small-scale alone were sold on the Internet (i.e. response to an average of 1,500 hours to
tobacco product manufacturers will 7,764 unique brand flavors averaging 4.4 complete a PMTA. In reaching this
assist small manufacturers. This different nicotine levels per brand) not average, FDA considered efficiencies
compliance policy will provide small- including different vegetable glycerin/ achieved through manufacturer
scale tobacco product manufacturers propylene glycol water levels or experience, application overlap,
(i.e., those manufacturers with 150 components in 466 identified different economies of scale, incorporation of
employees or fewer and $5,000,000 or e-cigarette brands. Several comments evidence by reference, and other means
less in annual revenues) with additional estimated that there are 5,000 to 15,000 including availability of the SE FAQ
time to submit ingredient reporting e-liquid producers and e-cigarette retail guidance. Based on this information,
(under sections 904 and 915) and health establishments in the United States. FDA believes an SE submission will
documents (under section 904). This Other comments projected that there are take considerably less time and money.
policy also provides that small-scale at least 100,000 e-cigarette products If the manufacturer is unable to show
tobacco product manufacturers may currently on the market. that its product is substantially
receive extensions of time for providing Similarly, some commenters felt that equivalent to a predicate product or that
responses to SE deficiency letters. FDA grossly underestimated the number its product is exempt from SE., then the
(Comment 284) Some comments of responses for certain proposed manufacturer must submit a PMTA. The
noted that the NPRM made it appear information collections. For example, requirements of a PMTA may vary based
that FDA would not allow any SE they noted that the NPRM states that on the type and complexity of the
reports to be submitted for e-cigarette FDA expects only 25 new product product.
products, as there were only about a half applications from e-cigarette (Comment 288) One comment said
dozen first generation e-cigarette manufacturers. They claimed that FDA that FDA erred in its estimate of the in-
products that were sold in the United has either miscalculated the number of house cost burdens imposed by the
States in February 2007 (the grandfather distinct brands and types of e-cigarettes proposed information collections. The
date), and those products are not on the market, or the Agency expects comment said internal costs can only be
substantially equivalent to any of most manufacturers to exit the market excluded when estimating the burden of
today’s products. Comments stated that rather than submit product applications. an information collection if such costs
applicants would then need to submit (Response) We have revised our are related to ‘‘usual and customary’’
PMTAs and estimated that each PMTA estimates to reflect the most recent activities. In this case, the comment
would cost a successful applicant information available at the time of believed FDA did not consider the types
between $3 and $20 million. drafting this final analysis. FDA of internal costs that will be incurred by
(Response) The FD&C Act provides estimates the average number of vape companies to comply with the
three pathways for obtaining FDA shops that meet the definition of a information collections.
authorization to market a new tobacco manufacturer are 4,250. FDA also (Response) FDA disagrees with this
product. Where a new product does not estimates that there will be 186 other comment. The Agency was thorough in
its identification of usual and customary did not provide empirical evidence of a PMTA process will be a significant
activities. The Agency used various different number of affected products. negative impact on small businesses.
existing data sources and considered all However, based on experience with (Response) The FD&C Act provides
the costs associated with the collections currently regulated products and for three marketing pathways for new
of information. In reaching this average changes in the industry we have revised tobacco products—SE to a valid
cost, FDA considered efficiencies the burden accordingly. The Agency predicate product, exemption from SE.,
achieved through manufacturer also finds that these comments have not and PMTA. If the manufacturer is
experience, application overlap, provided evidence as to why the unable to show that its product is
economies of scale, incorporation of grandfather date will cause applicants to substantially equivalent to a valid
evidence by reference, and other means. submit more SE applications than FDA predicate product or that its product is
(Comment 289) A few comments estimated. exempt from SE., then the firm must
stated that most of the cost burden (Comment 291) One comment argued submit a PMTA. The requirements and
created by paperwork requirements will that FDA has greatly underestimated the costs of a PMTA may vary based on the
fall upon consumers, as hundreds of number of premium cigar products that type and complexity of the product. For
thousands of American consumers will be subject to premarket review. example, where there is limited
would lose access to what the comments According to the comment, premium understanding of a product’s potential
state are ‘‘low-risk products’’ that have cigar makers are distinct from other impact on public health, several
allowed consumers to quit smoking. tobacco product manufacturers in the nonclinical and clinical studies may be
They said FDA should take into number of products they market and the required for market authorization. In
consideration small business and volume of those lines. This comment such case, the requirements and cost of
consumer stakeholders’ suggested stated that the average number of cigars the PMTA likely would be higher than
alternatives to minimize the NPRM’s produced for any given product in a for a product in which there is already
potential impact. year is 32,655, with 33.6 percent of substantial scientific data on the
(Response) FDA disagrees with these reported annual production rates at or potential public health impact.
comments. This final rule will prevent below 10,000 units. (Comment 292) Many comments
new products from entering the market noted that FDA included a small
Several other comments argued that
that are not appropriate for the number of PMTAs for e-cigarette
the typical premium cigar manufacturer
protection of the public health, are not products in its analysis. Some
may have over 100 unique stock keeping
substantially equivalent to a valid comments stated that if this is the case,
units (SKUs) and typically will turn
predicate product, or are not exempt FDA’s estimates would probably
over about 15 percent of those SKUs in
from SE. We also note that FDA is include only a fraction of the products
any given year. Their data indicates that are believed to be used to stop
announcing a compliance policy for
small-scale tobacco product there are at least 10,000 and maybe as smoking cigarettes. They commented
manufacturers, offering them targeted many as 20,000 unique SKUs in the that the cost burdens of the paperwork
relief in certain areas to address United States, which would add to requirements will result in an
concerns that smaller manufacturers FDA’s workload for evaluating new unnecessary price increase for the
may need additional time to comply product applications. They also consumer and the PMTA requirements
with certain requirements of the FD&C estimated that the premium hand-rolled will limit the availability of e-cigarettes
Act, as discussed in section IV.D. This cigar category alone could generate to addicted smokers trying to quit. Their
compliance policy will provide small- numbers in excess of 10,000 new concern is the burden of the paperwork
scale tobacco product manufacturers product applications. would fall on both merchants and
(i.e., those manufacturers with 150 Other comments stated that the consumers.
employees or fewer and $5,000,000 or premarket application process will be (Response) FDA disagrees with these
less in annual revenues) with additional costly and time consuming for cigar comments. The Agency’s intention is
time to submit ingredient listing manufacturers and will likely result in not to impose additional costs to
information (under section 904(a)(1)) many different kinds of newly deemed consumers but, instead, to prevent new
and health documents (under section tobacco products being removed from products from entering the market that
904(a)(4)). This policy also provides the marketplace. The constant variation are not appropriate for the protection of
that, for the first 30 months following in the cigar tobacco used to make the public health, are not substantially
the effective date of the rule, small-scale premium cigars will create significant equivalent to a predicate product, or are
tobacco product manufacturers may regulatory burdens and costs for cigar not exempt from SE. Per Agency
receive extensions of time for providing manufacturers to be constantly experience and updates in the industry,
responses to SE deficiency letters. submitting premarket applications. FDA has updated the number of ENDS
(Comment 290) Several comments Comments stated that cigar products we estimate will submit a
stated that FDA significantly manufacturers that are unable to bear PMTA.
underestimated the burden on the the cost of applications will cease (Comment 293) Some comments
tobacco industry. The Agency estimated bringing new products to the disagreed with FDA’s estimate that it
that 13,745 products will be affected by marketplace. expects only one ‘‘other tobacco, e-
the NPRM and almost 90 percent of The comments expressed similar cigarette and nicotine product
them were cigars and pipe tobacco. concerns regarding e-cigarettes, stating manufacturers’’ respondent to submit an
They noted that FDA estimated that up that each e-cigarette manufacturer annual health and toxicological report
to 7,869 products will submit SE reports would need to submit a PMTA for every and its estimate that there would only
within the first 24 months after the rule brand of e-cigarette currently being sold be one respondent to self-certify that its
is finalized, which they believed was and new e-cigarettes introduced into the product does not contain nicotine. They
very low, especially given the February marketplace. Small manufacturers may stated that there may be hundreds of e-
15, 2007, grandfather date. not have the financial resources to liquid manufacturers self-certifying for
(Response) FDA used available public submit PMTAs, which will result in the use of the alternative statement, because
information to estimate the burden on removal of e-cigarettes from the it is standard industry practice to offer
the tobacco industry and the comments marketplace. The end result of the 0 milligram nicotine flavors in vials.
(Response) At this time, we do not time for manufacturers to conduct any this time so long as a specified set of
have sufficient evidence to warrant required clinical studies in support of a documents are submitted by [the
revising the burden estimates. PMTA. effective date plus 6 months]. FDA will
(Comment 294) Many comments (Response) As stated throughout this publish additional guidance that
stated that FDA’s estimates do not document, FDA is providing a 24-month specifies the scope of such documents
reflect the realities of the market and compliance period for manufacturers to with sufficient advance time for
FDA’s estimates assume that most of submit (and for FDA to receive) a manufacturers and importers to prepare
these small companies will be forced to PMTA. If manufacturers submit the their submissions.
exit the industry because of the high appropriate applications during this (Comment 297) Some comments
compliance and paperwork burdens compliance period, FDA will not stated that FDA has underestimated the
envisioned by the NPRM. However, enforce against those manufacturers number of other tobacco product
others believed that as the market continuing to market their products manufacturers that will submit the
evolves, many companies will continue without FDA authorization for a certain required health documents.
to operate and comply with FDA’s time period. For products using the (Response) FDA based this burden
regulations. PMTA pathway, this compliance period estimate on the existing collection that
Further, many other comments stated closes 36 months after the effective date. applies to tobacco products currently
that, at best, FDA’s estimate that there Once the continued compliance period subject to the FD&C Act and FDA
are only 140 to 188 potential ends, FDA intends to actively monitor experience. The comments did not
respondents in the category of ‘‘other and enforce the premarket authorization provide a basis or an estimate of other
tobacco, e-cigarettes, and nicotine requirements regarding products on the tobacco product manufacturers for FDA
product manufacturers’’ is ‘‘egregiously market without authorization even if the to utilize in its review, and the Agency
off target’’ based on the available respective submission is still under is not aware of any information that
evidence. They believed that the entire review. As noted previously, FDA warrants changing this estimate. We
industry will be eliminated as a result expects that, in some cases, it will be note that at this time, FDA intends to
of the regulatory and paperwork possible for an applicant to obtain a limit enforcement to finished tobacco
burdens in the NPRM. They also noted PMTA order without conducting any products. A finished tobacco product
that the reason for the difference new nonclinical or clinical studies refers to a tobacco product, including all
between 140 and 188 in the Analysis of where there is an established body of components and parts, sealed in final
Impacts and PRA sections is unclear. evidence regarding the public health packaging intended for consumer use
(Response) There is a high level of impact of the product. Therefore, FDA (e.g., filters, filter tubes, e-cigarettes, or
uncertainty in the number of believes that many PMTAs may not e-liquids sold separately to consumers
manufacturers of ENDS. FDA is required require significant administrative or as part of kits). FDA does not at this
to estimate burden as part of the PRA resources associated with clinical time intend to enforce this requirement
analysis. As many comments describe, investigations. for components and parts of newly
the industry is ever changing; during the (Comment 296) Several comments deemed products that are sold or
time that the NPRM was in review, and noted that if FDA requires health distributed solely for further
since the NPRM was published, the documents from manufacturers and manufacturing into finished tobacco
ENDS industry has grown. The importers of newly deemed tobacco products. However, any component or
comments on the number of ENDS products, the Agency should establish a part of a newly deemed tobacco product
manufacturers provided industry similar production timeline as it did for that is sold directly to consumers as a
estimates rather than concrete data currently regulated products (i.e., ‘‘finished tobacco product’’ will be
sources. In the case of non-retail cigarettes, cigarette tobacco, smokeless required to comply with the premarket
manufacturers, the comment did not tobacco, and roll-your-own tobacco) and review requirements discussed
always specify whether the cited only require production of health throughout this document.
numbers included both domestic and documents developed during the 6- (Comment 298) Some comments
foreign manufacturers, or only domestic month period following the effective stated that e-liquid companies should be
manufactures. Therefore, considerable date of the regulation. allowed to amend their ingredient lists
uncertainty remains as to the number of (Response) As stated in the if they add or remove ingredients or
domestic non-retail manufacturers. compliance date tables, the compliance increase the maximum concentration of
Similarly, the comments did not address period for manufacturers of products any of their current ingredients in any
the number of non-retail importers. In currently on the market to submit health of their products, rather than submit a
the Regulatory Impact Analysis (RIA) for documents is 6 months after the new ingredient list for the new product.
this final rule, based on logo counts effective date of the final rule. (Response) Ingredient listings contain
from trade association Web sites and Manufacturers of products entering the important data that enable FDA to gain
FDA listening sessions, it is estimated market after the effective date of the better understanding of the contents of
that there are 168 to 204 formal final rule must comply within 90 days regulated products. This information
manufacturers of ENDS products (not before delivery of the product for will assist FDA in assessing potential
including ENDS retail establishments introduction into interstate commerce. health risks and determining if future
that meet the definition of a With this final rule, FDA also is regulations to address these health risks
manufacturer). For the PRA analysis, we announcing that it will extend the are warranted. In addition, when an e-
took the average for a total of 186 compliance period for an additional 6 liquid manufacturer adds or removes
manufacturers. We also estimate that months from the effective date to allow ingredients from a product, it becomes
there are 14 importers of ENDS small-scale tobacco product a ‘‘new tobacco product.’’
products. manufacturers time to organize, (Comment 299) Several comments
(Comment 295) Many comments compile, and digitize documents. disagreed with FDA’s proposed
stated that it would not be possible to Additionally, as stated elsewhere, FDA premarket review burdens for pipe
complete a PMTA within 24 months generally does not intend to take tobacco manufacturers. At least one
after the effective date of the final rule enforcement action regarding the comment indicated that FDA’s proposed
and that it is an insufficient amount of submission of all such documents at estimate that it will receive only one
new product application for pipe from trade association Web sites and 4. Ways To Minimize the Burden of the
tobacco products grossly underestimates FDA listening sessions, it is estimated Collection of Information on
the number of brands of pipe tobacco that there are 168 to 204 formal Respondents, Including Through the
that have entered the market since 2007 manufacturers of ENDS products. For Use of Automated Collection
or indicates that the Agency expects all the PRA analysis, we took the average Techniques, When Appropriate, and
but one manufacturer to voluntarily stop of 168 and 204 for a total of 186 Other Forms of Information Technology
production of new pipe tobacco manufacturers. We also estimate that (Comment 304) One comment
products without submitting an SE there are 14 importers of ENDS asserted that, under the PRA, a review
report or PTMA application. In products. of regulations should include an attempt
addition, the comments stated that pipe
(Comment 301) A number of to ensure that the paperwork is not
tobacco manufacturers will incur cost
comments also noted that FDA should unduly burdensome. The comment also
and time burdens if they are required to
be required to estimate and report the stated that FDA appears to be ignoring
submit PMTAs for each new blend of
full social costs of eliminating what they the greatest cost of the paperwork
pipe tobacco that they manufacture,
including millions of dollars per year in considered to be beneficial products burden (i.e., most manufacturers will
research to prepare the PMTAs. from the market where the find the paperwork burden to be so great
(Response) At this time, FDA finds that they will abandon products or their
manufacturers are unable to afford the
there is insufficient evidence to increase entire businesses without attempting to
PMTA costs.
the burden estimates. FDA believes that comply with the requirements). They
(Response) FDA is not aware of any argued that FDA should follow the
pipe tobacco manufacturers will utilize
evidence indicating that such social requirements as stated in the PRA and
the SE and SE exemption pathways. We
believe they are manufactured similarly costs will accrue. Nevertheless, such limit data collection to information that
with few, if any, modifications and estimates are outside the scope of the is useful and dependable.
many of the ingredients and suppliers PRA analysis. (Response) FDA disagrees with this
are the same as those utilized in comment. FDA has faithfully complied
3. Ways To Enhance the Quality, Utility, with the all aspects of the PRA and any
previous years. and Clarity of the Information To Be
(Comment 300) Several comments other applications laws and regulations.
Collected
pointed out inconsistencies between the B. Existing Burdens Associated With
PRA and Analysis of Impacts sections in (Comment 302) One comment stated Tobacco Products Currently Subject to
the NPRM. They noted that the Analysis that FDA has not consulted with the FD&C Act (i.e., Cigarettes, Cigarette
of Impacts clearly states that FDA does industry nor has the Agency audited Tobacco, Roll-Your-Own Tobacco, and
not have an estimate of e-cigarette industry recordkeeping to support the Smokeless Tobacco) With Approved
entities that would register with FDA. If assumption that manufacturers have OMB Control Numbers
FDA could not estimate the number of
enough information to prepare SE The information collection
affected entities in the Analysis of
reports. requirements referenced in this section
Impacts, they believed this should also
be reflected in the PRA section. In (Response) FDA’s proposed burden are amending currently approved
addition, they stated that the estimated estimates are based on information information collections. Once the rule is
number of PMTAs (25) in the PRA available at the time of preparing the finalized, the associated collections of
section contradicts the number of NPRM. If interested parties have information will be submitted to OMB
estimated PMTAs in the Analysis of evidence that warrants revising these for approval as revisions to the currently
Impacts. burden estimates, they were requested approved information collections. After
(Response) The RIA and PRA analyses to submit such evidence during the submission to OMB, the revised
are conducted to fulfill different comment period for FDA to take into collections and associated documents
purposes and must adhere to different account when preparing final burden can be viewed at OMB’s public Web site
requirements; as a result, the two estimates. (http://www.reginfo.gov).
analyses would rarely, if ever, be the The burden estimates found in this
same. For example, the time horizons (Comment 303) One comment section include existing collections that
for the analyses are typically different. recommended that the Office of have been approved by OMB and cover
Information collections are approved for Information and Regulatory Affairs tobacco products that are currently
a up to a 3-year period and are (OIRA) should void the proposed subject to the FD&C Act (i.e., cigarettes,
reanalyzed every time they are up for regulations as they relate to e-cigarettes, cigarette tobacco, roll-your-own tobacco,
extension, whereas a prospective RIA is that OIRA and FDA should urge and smokeless tobacco). In developing
conducted before a rule is issued using Congress to work with FDA to create a the burden estimates for newly deemed
a time horizon chosen to capture the new regulatory framework for e- tobacco products, FDA based the
most important effects of the rule cigarettes, and, at the very least, that estimates on the existing collections that
(generally 20 years). If estimates differ OIRA require that FDA prepare new currently cover cigarettes, cigarette
from year to year, the RIA will often estimates of the paperwork burdens. tobacco, roll-your-own tobacco, and
explicitly identify how the estimates smokeless tobacco.
(Response) FDA disagrees with this
vary, whereas the PRA analysis will
comment. FDA has estimated the PRA 1. Tobacco Product Establishment
most often use an average or the
burdens with the best evidence that is Registration and Submission of Certain
estimate for the current year. Regulatory

currently available. In addition, as Health Information (OMB Control
impact analyses also tend to make more
stated in the NPRM and throughout this Number 0910–0650)
frequent use of ranges rather than point
estimates. final rule, the deeming provisions are Description of Respondents: The
As referenced previously, there is a beneficial to the public health and the respondents to this collection of
high level of uncertainty in the number additional provisions are appropriate for information are manufacturers or
of manufacturers for ENDS. In the RIA the protection of the public health. importers, or agents thereof, of new and
for this final rule, based on logo counts currently regulated tobacco products
who are required to make submissions If an ENDS retail establishment final rule for initial reporting of
to FDA under section 904 of the FD&C engages in these activities, it will be ingredients. This regulatory relief is
Act, including the submission of an required to register and list their only for small-scale tobacco product
initial list of all ingredients in their products with FDA. These requirements manufacturers.
tobacco products and the submission of apply under the statute for all distinct FDA issued guidance documents on
information whenever additives or their products manufactured, and they enable both (1) Registration and Product Listing
quantities are changed. The respondents FDA to assess the landscape of products for Owners and Operators of Domestic
to this collection are also persons manufactured by these entities. If ENDS Tobacco Product Establishments (74 FR
engaged in the manufacture, retail establishments are custom mixing
58298, November 12, 2009) and (2)
preparation, compounding, or e-liquids and/or other ENDS products or
Listing of Ingredients in Tobacco
processing of a tobacco product or components, then they will have to list
Products (74 FR 62795, December 1,
tobacco products who must register each combination that they sell. For
2009) to assist persons making these
their establishments and submit a list of such establishments to continue to
engage in mixing after this rule becomes submissions to FDA under the FD&C
all tobacco products being Act. Although electronic submission of
manufactured, prepared, compounded, effective, they would need to satisfy the
requirements for manufacturers and the registration, product listing, and
or processed by that person for ingredient listing information are not
commercial distribution at the time of premarket authorization of new tobacco
products as a result of this final rule. We required, FDA strongly encourages
registration under section 905 of the electronic submission to facilitate
FD&C Act. note, however, that FDA does not intend
to enforce the premarket authorization efficiency and timeliness of data
Section 101 of the Tobacco Control requirements during staggered management and collection. To that
Act amended the FD&C Act by adding compliance periods following the end, FDA designed the eSubmitter
sections 905 and 904. Section 905(b) of effective date, as stated previously in application, and then the FDA FURLS,
the FD&C Act requires that every person this preamble to this rule. to streamline the data entry process for
who owns or operates any establishment Section 904(a)(1) of the FD&C Act registration, product listing, and
in any State engaged in the requires each tobacco product ingredient listing. This tool allows for
manufacture, preparation, manufacturer or importer, or agent importation of large quantities of
compounding, or processing of a thereof, to submit a listing of all structured data, attachments of files
tobacco product or tobacco products ingredients, including tobacco, (e.g., in PDFs and certain media files),
register with FDA the name, places of substances, compounds, and additives and automatic acknowledgement of
business, and all establishments owned that are added by the manufacturer to FDA’s receipt of submissions. FDA also
or operated by that person. Section the tobacco, paper, filter, or other part developed paper forms (Form FDA
905(i)(1) of the FD&C Act requires that of each tobacco product by brand and by 3741—Registration and Listing for
all registrants, at the time of registration, quantity in each brand and subbrand. Owners and Operators of Domestic
must submit to FDA a list of all tobacco Section 904(c) of the FD&C Act also Tobacco Product Establishments and
products that are being manufactured, requires submission of information Form FDA 3742—Listing of Ingredients
prepared, compounded, or processed by whenever additives or their quantities in Tobacco Products) as alternative
that person for commercial distribution, are changed. submission tools. Both the FURLS and
along with certain accompanying As previously referenced in section the paper forms can be accessed at
consumer information and other IV, for small-scale tobacco product http://www.fda.gov/tobacco. FDA
labeling for such products and a manufacturers, FDA is providing a one- estimates the additional annual burden
representative sampling of time allowance of an additional 6 for the information collection as a result
advertisements. months after the effective date of this of this rule as follows:
TABLE 7—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of re- Average burden per
Number of re- Total annual
Activity sponses per response Total hours
spondents responses
respondent 2 (in hours)
Tobacco Product Establishment Initial First Year Registration (electronic and paper submission):
Cigar Entities (Including Large and Small, and Im- 221 1 221 2 ................................ 442
porters).
Pipe and Waterpipe Tobacco Entities (Including 96 1 96 2 ................................ 192
Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine Product 193 1 193 2 ................................ 386
Entities and ENDS Products Importers (7) 3.
Vape shops that qualify as manufacturers 4 ............ 4,250 1 4,250 2 ................................ 8,500
Total Tobacco Product Establishment Initial ........................ ........................ ........................ .................................... 9,520
First Year Registration.
Tobacco Product Establishment Recurring Registration (electronic and paper submission):
Cigar Entities (Including Large and Small, and Im- 221 1 221 0.20 (12 minutes) ...... 44
porters).
Pipe and Waterpipe Tobacco Entities (Including 96 1 96 0.20 (12 minutes) ...... 19
Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine Product 193 1 193 0.20 (12 minutes) ...... 39
TABLE 7—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued

Number of re- Average burden per
Number of re- Total annual
Activity sponses per response Total hours
spondents responses
Vape shops that qualify as manufacturers 4 ............ 4,250 1 4,250 0.20 (12 minutes) ...... 850
Total Tobacco Product Establishment Recurring ........................ ........................ ........................ .................................... 952
Registration.
Tobacco Product Listing Initial First Year (electronic and paper submission):
Cigar Entities (Including Large and Small, and Im- 221 1 221 2 ................................ 442
porters).
Pipe and Waterpipe Tobacco Entities (Including 96 1 96 2 ................................ 192
Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine Product 193 1 193 2 ................................ 386
Entities and ENDS Products Importers (7)) 3.
Vape shops that qualify as manufacturers 4 ............ 4,250 1 4,250 2 ................................ 8,500
Total Hours Tobacco Product Listing Initial ........................ ........................ ........................ .................................... 9,520
First Year.
Tobacco Product Listing Recurring (electronic and paper submission):
Cigar Entities (Including Large and Small, and Im- 221 2 442 0.40 (24 minutes) ...... 177
porters).
Pipe and Waterpipe Tobacco Entities (Including 96 2 192 0.40 (24 minutes) ...... 77
Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine Product 193 2 386 0.40 (24 minutes) ...... 154
Vape shops that qualify as manufacturers 4 ............ 4,250 2 8,500 0.40 (24 minutes) ...... 3,400
Total Hours Tobacco Product Listing Recur- ........................ ........................ ........................ .................................... 3,808
ring.
Obtaining a Dun and Bradstreet (DUNS) Number:
Cigar Entities (Including Large and Small, and Im- 221 1 221 0.5 (30 minutes) ........ 111
porters).
Pipe and Waterpipe Tobacco Entities (Including 96 1 96 0.5 (30 minutes) ........ 48
Importers (22)).
Other Tobacco, E-Cigarettes, and Nicotine Product 193 1 193 0.5 (30 minutes) ........ 97
Vape shops that qualify as manufacturers 4 ............ 4,250 1 4,250 0.5 (30 minutes) ........ 2,125
Total Hours Obtaining DUNS Number ............. ........................ ........................ ........................ .................................... 2,381
Total Hours Registration, Product Listing, ........................ ........................ ........................ .................................... 26,181
and DUNS Number.
Tobacco Product Ingredient Listing (electronic and paper submission):
Cigar Entities (Including Large and Small, and Im- 329 5.38 1,770 3 ................................ 5,310
porters).
Pipe and Waterpipe Tobacco Entities (Including 117 20.62 2,413 3 ................................ 7,239
Importers (43)).
Other Tobacco, E-Cigarettes, and Nicotine Product 200 11.40 2,280 3 ................................ 6,840
Vape shops that qualify as manufacturers 4 ............ 4,250 11.73 49,853 1 ................................ 49,853
Total Hours Submitting Product Ingredient ........................ ........................ ........................ .................................... 69,242
Listing.
Total Burden Tobacco Product Establish- ........................ ........................ ........................ .................................... 121,604
ment Registration and Submission of
Certain Health Information.

1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Thisnumber is estimated to be the total annual responses divided by the number of respondents, rounded to the nearest tenth.
3 Importers are included throughout this Table 7 to the extent that they engage in the manufacture, preparation, compounding, or processing of
tobacco products, which includes repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in fur-
therance of the distribution of the tobacco product from the original place of manufacturer to the person who makes final delivery or sale to the
ultimate consumer or use.
4 FDA assumes that vape shops will register and list only during the first two years after the rule becomes effective.
Based on aggregate information FURLs system, manufacturers can enter assumes that all the establishment
obtained from the TTB, in 2013 there information quickly and easily. For facilities that will be required to register
were 113 domestic manufacturers of example, product label pictures can be under section 905 of the FD&C Act
cigars, 216 importers of cigars, 74 uploaded directly and we anticipate that would obtain a DUNS number, with a
manufacturers of pipe (including most, if not all companies, already have total of 4,760 establishments that would
waterpipe) tobacco, and 43 importers of electronic versions of their labels for need to obtain this number. The total
pipe (including waterpipe) tobacco who printing, sales, or marketing purposes. burden to obtain a DUNS number is
will be required to register under We anticipate that initial entity 26,181 hours.
section 905 of the FD&C Act. For the registration will take 2 hours and initial FDA estimates that the submission of
purposes of this analysis, FDA estimates product listing will take an additional 2 ingredient listing information as
that the majority of the 4,250 vape shops hours per entity. required by section 904 of the FD&C Act
that qualify as manufacturers will only FDA estimates that the initial first will take 3 hours per tobacco product
register and list in the first two years year submission of registration based on the estimates found in the
after the rule becomes effective. In information required by section 905 of existing collection. The Agency
addition, FDA estimates that 186 ENDS the FD&C Act will take 2 hours per estimates that approximately 56,316
manufacturers will be required to establishment, with a total of 4,760 ingredient listings/annual responses
register under section 905 of the FD&C establishments that will be required to will be submitted annually based on the
Act. register under this rule, for a total of methodology used for estimating the
Product listing information is 9,520 hours (4,760 × 2). number of product listing submissions
provided at the time of registration. The estimate for the number of described in this section. The total
Currently, registration and listing product listing submissions for cigars is ingredient listing reporting is 69,242
requirements only apply to domestic derived by using product counts from hours. FDA estimates that the total
establishments engaged in the two retail Web sites: http:// burden for tobacco product
manufacture, preparation, www.cigarsinternational.com/ and establishment registration and
compounding, or processing of a http://www.pipesandcigars.com/. These ingredient listing reporting is 121,604
tobacco product. This includes two large Internet retailers had larger hours.
importers to the extent that they engage product offerings than other sites
reviewed and sell both mass-market and 2. Tobacco Health Document
in the manufacture, preparation,
specialty products. Estimates of product Submission (OMB Control Number
compounding, or processing of a
formulations and product-package 0910–0654)
tobacco product, including repackaging
or otherwise changing the container, combinations for cigars are centered Description of Respondents:
wrapper, or labeling of any tobacco over the product counts from the two Respondents to this collection of
product package.18 Foreign Web sites. To derive the product listing information are tobacco product
establishments are not required to count for pipe tobacco, we count the manufacturers or, importers, or agents
register and list until FDA issues products on a Web site with a broad thereof, who will submit all documents
regulations establishing such product offering, http:// to FDA developed after June 22, 2009,
requirements in accordance with section www.pipesandcigars.com/. We estimate that relate to health, toxicological,
905(h) of the FD&C Act. To account for formulations with the number of the behavioral, or physiologic effects of
the foregoing, we include both domestic product names and product-packages current or future tobacco products. As
manufacturing establishments and with the number of product-package stated elsewhere, however, FDA
importers in our estimates. Specifically, combinations. FDA derives the product generally does not intend to take
for the PRA analysis, we have used the listing estimate for ENDS products by enforcement action regarding the
midpoint between TTB permit counts consulting experts at FDA’s CTP who submission of all such documents at
for manufacturers and permit counts for cataloged the ENDS products currently this time so long as a specified set of
manufacturers and importers as a likely available on five Web sites and in documents are submitted by [the
overestimate of the number of entities scanner data from Nielsen. FDA effective date plus 6 months]. FDA will
that need to comply with registration estimates that the initial first year publish additional guidance that
and product listing (The Analysis of submission of product listing specifies the scope of documents that
Impacts includes importers in the upper information required by section 905 of manufacturers and importers will be
bound.) the FD&C Act will take 2 hours per required to submit by [the effective date
The PRA burden estimates have been submission for 4,760 submissions/ plus 6 month], with sufficient advance
updated to fully incorporate the use of annual responses for a total of 9,520 time for manufacturers and importers to
an electronic system known as FURLs hours. prepare their submissions.
for submitting registration and product Once information is entered into Section 904(a)(4) of the FD&C Act
listing information to FDA. With the FURLs, the twice yearly confirmation of requires each tobacco product
annual registration and product listing manufacturer or importer, or agent
18 Under the Internal Revenue Code, the updates is simplified as all information thereof, to submit all documents to FDA
manufacture, preparation, compounding, or previously entered is maintained in the developed after June 22, 2009, that
processing of a tobacco product may require a
permit as a manufacturer of tobacco products. As
system. Therefore, we expect the relate to health, toxicological,
we understand TTB’s permitting requirements, recurring burden of subsequent years for behavioral, or physiologic effects of
entities lacking a manufacturer permit, including updating registration and product listing current or future tobacco products, their
importers, may not engage in any of the listed information will take 1 hour annually constituents (including smoke
activities, including repackaging tobacco products
after such products are released from customs per establishment (12 minutes for constituents), ingredients, components,
custody. It is unclear whether TTB would require registration and 48 minutes for product and additives (tobacco health
a manufacturer permit for all activities for which listing). The total hours are 4,760 (952 documents). To address concerns of
FDA would determine the entity must register and updating registration and 3,808 product certain small businesses relating to the
list; because there may be some entities with import
permits for which FDA would conclude registration listing). tobacco health documents requirement,
is necessary, FDA includes those numbers as part FDA estimates that obtaining a DUNS FDA is extending the compliance period
of its upper-bound estimate of affected entities. number will take 30 minutes. FDA for small-scale tobacco product
manufacturers for an additional 6 FDA is collecting the information 3743) for those individuals who choose
months following the end of the submitted under section 904(a)(4) of the not to use the electronic portal.
generally applicable compliance period FD&C Act through an electronic portal FDA estimates the additional annual
to allow submitters time to organize, and through a paper form (Form FDA burden for the information collection as
compile, and digitize documents. a result of this rule as follows:
Average
Number of
Number of Total annual burden per
Activity responses per Total hours
respondents responses response
respondent (in hours)
Cigar Manufacturers (Including Large and Small) ............... 2 4 8 50 400

Pipe and Waterpipe Tobacco Manufacturers ...................... 1 4 4 50 200
Other Tobacco, E-Cigarettes, and Nicotine Product Manu-
facturers ENDS ................................................................ 1 4 4 50 200
Importers of Cigars and Pipe Tobacco Who Are Consid-
ered Manufacturers .......................................................... 1 4 4 50 200
Importers of Other Tobacco, E-Cigarettes, and Nicotine
Product Manufacturers ENDS .......................................... 1 4 4 50 200
Total Hours Health Document Submission .................. ........................ ........................ ........................ ........................ 1,200
FDA estimates that a tobacco health final rule). The SE exemptions final rule increasing or decreasing the quantity of
document submission for cigars, pipe was issued under section 905(j)(3) of the an existing tobacco additive;
and waterpipe tobacco, other tobacco, FD&C Act, which provides that FDA • a detailed explanation of why the
tobacco importers, and importers of may exempt from the requirements modification is a minor modification of
ENDS required by section 904(a)(4) of relating to the demonstration of SE a tobacco product that can be sold under
the FD&C Act, will take approximately tobacco products that are modified by the FD&C Act;
50 hours per submission based on the adding or deleting a tobacco additive, or • a detailed explanation of why a
existing collection that applies to increasing or decreasing the quantity of report under section 905(j)(1)(A)(i)
tobacco products currently subject to an existing tobacco additive, if FDA intended to demonstrate SE is not
the FD&C Act and FDA experience. To determines that: (1) Such modification necessary to ensure that permitting the
derive the number of respondents for would be a minor modification of a tobacco product to be marketed would
this provision, FDA assumes that very tobacco product that can be sold under be appropriate for the protection of the
few manufacturers or importers, or the FD&C Act, (2) a report is not public health;
agents thereof, would have health necessary to ensure that permitting the
documents to submit. Therefore, the tobacco product to be marketed would • a certification summarizing the
Agency estimates that approximately six be appropriate for protection of the supporting evidence and providing the
submissions (two for cigar public health, and (3) an exemption is rationale for why the modification does
manufacturers, one for pipe and otherwise appropriate. not increase the tobacco products
waterpipe tobacco manufacturers, one appeal to or use by minors, toxicity,
The exemption request may be made addictiveness, or abuse liability;
for other tobacco product only by the manufacturer of a legally
manufacturers, and one for tobacco marketed tobacco product for a minor • other information justifying an
importers, and one for importers of modification to that manufacturer’s exemption; and
ENDS who are considered product, and the request (and • an environmental assessment under
manufacturers) will be submitted on an supporting information) must be part 25 (21 CFR part 25) prepared in
annual basis. FDA estimates the total submitted in an electronic format that accordance with § 25.40.
number of hours is 1,200 hours (6 FDA can process, review, and archive. This information will enable FDA to
submissions multiplied by 4 times per In addition, the request and all determine whether the exemption
year multiplied by 50 average burden supporting information must be legible request is appropriate for the protection
hours). and in (or translated into) the English of the public health. There is also a
3. Exemptions From Substantial language. procedural mechanism for rescinding an
Equivalence Requirements (OMB An exemption request must be exemption if FDA finds the exemption
Control Number 0910–0684) submitted with supporting is not appropriate for the protection of
documentation and contain: the public health. In general, FDA will
Description of Respondents: rescind an exemption only after
Respondents to this collection of • The manufacturer’s address and
providing the manufacturer notice of the
information are manufacturers of contact information;
rescission and an opportunity for an
• identification of the tobacco
deemed tobacco products who are informal hearing under part 16 (21 CFR
requesting an exemption from the SE product(s); part 16). However, FDA may rescind an
requirements of the FD&C Act. • a detailed explanation of the exemption prior to notice and
In a final rule that published on July purpose for the modification; opportunity for a hearing under part 16
5, 2011, FDA established procedures for • a detailed description of the if the continuance of the exemption
manufacturers to request exemptions modification, including a statement as presents a serious risk to public health.
from the SE requirements of the to whether the modification involves In that case, FDA would provide the
Tobacco Control Act (SE exemptions adding or deleting a tobacco additive, or manufacturer an opportunity for a
hearing as soon as possible after the specified in the statute are satisfied. timeframe requested, FDA will consider
rescission. FDA may request additional information the exemption request withdrawn.
FDA reviews the information from the manufacturer if necessary to FDA estimates the additional annual
submitted in support of the request and make the determination. If the burden for the information collection as
determines whether to grant or deny the manufacturer fails to respond within the a result of this rule as follows:
request based on whether the criteria
TABLE 9—ESTIMATED ANNUAL REPORTING BURDEN (WHEN MANUFACTURERS CHOOSE TO SEEK EXEMPTION FROM
SUBSTANTIAL EQUIVALENCE) 1
Average
Number of
21 CFR Section and activity responses per Total hours
§ 1107.1(b) Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request Including § 25.40 Preparation of
an Environmental Assessment
Cigar Manufacturers (Including Large, Small, and Import-

ers) ................................................................................... 196 1 196 24 4,704
Pipe and Waterpipe Tobacco Manufacturers (Including Im-
porters) ............................................................................. 105 1 105 24 2,520
facturers (ENDS and Delivery Systems (Including Im-
porters)) ............................................................................ 18 1 18 24 432
Total Hours (§ 1107.1(b)) .............................................. ........................ ........................ ........................ ........................ 7,656
§ 1107.1(c) Preparation of Additional Information for Tobacco Product Exemption From Substantial Equivalence Request:

ers) ................................................................................... 59 1 59 3 177
porters) ............................................................................. 32 1 32 3 96
porters)) ............................................................................ 3 1 3 3 9
Total Hours (§ 1107.1(c)) .............................................. ........................ ........................ ........................ ........................ 282
Section 905(j)(1)(A)(ii) of the FD&C Act: If exemption granted, report submitted to demonstrate tobacco product is modified under sec-
tion 905(j)(3), modifications are to a product that is commercially marketed and compliant, and modifications covered by exemp-
tions granted by Secretary under section 905(j)(3):

ers) ................................................................................... 293 1 293 3 879
Pipe and Waterpipe Tobacco Manufacturers (including im-
porters) ............................................................................. 156 1 156 3 468
porters)) ............................................................................ 26 1 26 3 78
Total Hours (section 905(j)(1)(A)(ii)) ............................. ........................ ........................ ........................ ........................ 1,425
Total Hours Exemptions From Substantial

Equivalence Requirements ................................ ........................ ........................ ........................ ........................ 9,363
2 This number is estimated to be the total annual responses divided by the number of respondents, rounded to the nearest hundredth.
The estimated average burden per Substantial Equivalence Request), the FDA estimates that 475 respondents
response (in hours) is based on the burden per response for EAs (12 hours) will prepare 475 responses and each
burdens associated with the existing has been combined with the 12 hours response will take approximately 3
information collection that applies to for an SE request for a total of 24 hours. hours to prepare, as required by section
tobacco products currently subject to FDA estimates, based on the existing 905(j)(1)(A)(ii), for a total of 1,425 hours.
the FD&C Act (i.e., cigarettes, cigarette information collection that applies to This collection of information requires a
tobacco, roll-your-own tobacco, and tobacco products currently subject to manufacturer to submit a report at least
smokeless tobacco). FDA estimates that the FD&C Act, we will receive 94 90 days prior to making an introduction
we will receive 319 exemption requests submissions requiring additional or delivery for introduction into
under § 1107.1(b) for 24 hours per information in support of the initial interstate commerce for commercial
response including EA for a total of exemption request, and it is expected distribution of a tobacco product.
7,656 hours. Since an EA is required for that it will take an average of 3 hours Section 905(j)(1)(A)(ii) of the FD&C Act
each § 1107.1(b) (Optional Preparation to prepare the additional information for states that if an exemption has been
of Tobacco Product Exemption From a total of 282 hours. requested and granted, the manufacturer
must submit to FDA a report that Section 905(j)(1) of the FD&C Act Same Characteristics SE Report. If the
demonstrates that the tobacco product is authorizes FDA to establish the form only change to the tobacco product is a
modified within the meaning of section and manner of the submission. FDA change to product quantity, and the per-
905(j)(3), the modifications are to a issued guidance intended to assist weight composition inside the package
product that is commercially marketed persons submitting reports under remains identical, the manufacturer may
and in compliance with the section 905(j) of the FD&C Act and to submit a Product Quantity Change SE
requirements of the FD&C Act, and all explain, among other things, FDA’s Report. FDA’s CTP estimates that it will
of the modifications are covered by interpretation of the statutory sections take less time to prepare those shorter
exemptions granted by the Secretary related to SE (see the Guidance for SE reports.
pursuant to section 905(j)(3). FDA Industry and FDA Staff entitled When groups of full or product
estimated the total hours for exemptions ‘‘Section 905(j) Reports: Demonstrating quantity change SE reports have
from Substantial Equivalence Substantial Equivalence for Tobacco identical content, they may be bundled;
Requirements would be 9,363 hours. Products’’ (76 FR 789, January 6, 2011)). when a group of similar reports are
FDA’s estimates are based on full Under the recently issued guidance, bundled, the subsequent bundled
analysis of economic impacts (Ref. 204) which published in the Federal Register reports are expected to take less time to
and information gathered from other of September 8, 2015, entitled, prepare than the initial report.
FDA-regulated products. ‘‘Demonstrating the Substantial
Equivalence of a New Tobacco Product: FDA recognizes that many
4. Reports Intended To Demonstrate the Responses to Frequently Asked manufacturers of newly deemed
Substantial Equivalence of a New Questions’’ (Edition 2), FDA is products may be at the inception of
Tobacco Product (OMB Control Number recommending that certain their businesses. Therefore, FDA is
0910–0673) modifications might be addressed in announcing that the Agency may grant
Description of Respondents: either a ‘‘Same Characteristics SE extension requests made by small-scale
Respondents to this collection of Report’’ or ‘‘Product Quantity Change tobacco product manufacturers for SE
information are manufacturers of Report.’’ In some circumstances Reports that need additional time to
deemed tobacco products who seek to manufacturers may be able to submit a respond to deficiency letters for the first
submit a report to FDA demonstrating shorter SE report. In particular, if a 30 months following the effective date
that a tobacco product is substantially tobacco product is distinct (e.g., it has of this rule.
equivalent to a valid predicate product a different name), but has the same FDA estimates the additional annual
under section 905(j)(1)(A)(i) of the FD&C characteristics as a valid predicate burden for the information collection as
Act. product, manufacturers may submit a a result of this rule as follows:

Average
Number of
Full SE Initial Sections 905(j)(1)(A)(i) and 910(a) and § 25.40 Environmental Assessments:

ers) ................................................................................... 168 1 168 300 50,400
porters) ............................................................................. 151 1 151 300 45,300
porters)) ............................................................................ 16 1 16 300 4,800
Total Hours (sections 905(j)(1)(A)(i) and 910(a)) ......... ........................ ........................ ........................ ........................ 100,500
Full SE Bundled 905(j)(1)(A)(i) and 910(a) and § 25.40 Environmental Assessments:

ers) ................................................................................... 151 1 151 90 13,590
Pipe and Water Tobacco Manufacturers (Including Import-
ers) ................................................................................... 83 1 83 90 7,470
porters)) ............................................................................ 16 1 16 90 1,440
Total Hours ................................................................... ........................ ........................ ........................ ........................ 22,500
Same Characteristics SE Report and § 25.40 Environmental Assessments:


ers) ................................................................................... 285 1 285 47 13,395
porters) ............................................................................. 132 1 132 47 6,204
facturers (ENDS and Delivery systems (Including Im-
porters)) ............................................................................ 1 1 1 47 47
TABLE 10—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued

Average
Number of
Total Same Characteristics .......................................... ........................ ........................ ........................ ........................ 19,646
Product Quantity Change Initial and § 25.40 Environmental Assessments:

ers) ................................................................................... 108 1 108 87 9,396
porters) ............................................................................. 30 1 30 87 2,610
porters)) ............................................................................ 1 1 1 87 87
Total Product Quantity Change Initial .......................... ........................ ........................ ........................ ........................ 12,093
Product Quantity Change Bundled and § 25.40 Environmental Assessments:

ers) ................................................................................... 42 1 42 62 2,604
porters) ............................................................................. 12 1 12 62 744
porters)) ............................................................................ 1 1 1 62 62
Total Product Quantity Change .................................... ........................ ........................ ........................ ........................ 3,410
Total Hours (‘‘Reports Intended to Demonstrate

the Substantial Equivalence of a New Tobacco
Product’’) ............................................................ ........................ ........................ ........................ ........................ 158,149
2 This number is estimated to be the total annual responses divided by the number of respondents, rounded to the nearest hundredth.
FDA has based these estimates on the Product Quantity Change Bundled SE that foreign-origin, FDA-regulated foods,
full analysis of economic impacts (Ref. reports for a total of 3,410 hours. Based drugs, cosmetics, medical devices,
204) and experience with the existing on FDA’s experience with radiological health, and tobacco
information collection that applies to environmental assessments (EAs) for products being imported or offered for
tobacco products currently subject to currently regulated tobacco products, import into the United States meet the
the FD&C Act (i.e., cigarettes, cigarette we expect industry to spend 80 hours to same requirements of the FD&C Act as
tobacco, roll-your-own tobacco, and prepare an environmental assessment domestic products and for preventing
smokeless tobacco). In addition, anyone for a full SE Report, but less time to products from entering the country if
submitting an SE report is required to prepare an environmental assessment they are not in compliance. The
submit an environmental assessment for shorter SE reports. discharge of this responsibility involves
under § 25.40. Therefore, FDA estimates the burden close coordination and cooperation
The burden for environmental reports for submission of SE information will be between FDA headquarters and field
has been included in the burden per 158,149 hours. inspectional personnel and the U.S.
response for each type of SE report. Customs and Border Protection (CBP).
5. Electronic Importer’s Entry Notice This collection of information is being
FDA estimates that 335 respondents (OMB Control Number 0910–0046)
will prepare and submit 335 section used by FDA to review and prevent
905(j)(1)(A)(i) Full SE Initial reports Description of Respondents: imported products from entering the
each year and that it will take a Respondents to this collection of United States if the products do not
manufacturer approximately 300 hours information are importers of tobacco meet the same requirements of the
per report to prepare the reports of SE products being imported or offered for FD&C Act as do domestic products.
and environmental assessment for a new import into the United States whose Until October 1995, importers were
tobacco product. products meet the same requirements of required to file manual entry on OMB-
FDA estimates that we will receive the Tobacco Control Act as domestic approved forms, which were
335 Full SE Initial reports for a total of tobacco products. accompanied by related documents.
100,500 hours. We estimate 250 Full SE With the passage of the Tobacco Information provided by these forms
Bundled Reports for a total of 22,500 Control Act, section 801 of the FD&C included information such as country of
hours. FDA estimates that we will Act (21 U.S.C. 381) was amended to add origin, name of the importing vessel,
receive 418 Same Characteristics SE tobacco products to the inventory of entry number (assigned by CBP), port of
Reports for a total of 19,646 hours. FDA FDA-regulated products. The revised entry, the port of lading and unlading,
estimates receiving 139 Initial Product section 801 charges the Secretary of value in U.S. dollars, shipper or
Quantity Change reports for a total of Health and Human Services, through manufacturer, importer of record,
12,093 hours. We estimate receiving 55 FDA, with the responsibility of assuring original consignee, broker, broker’s
reference number and CBP house box automated nationwide entry processing electronically by filers to CBP. Because
number, bill of lading numbers, and system, which enabled FDA to more CBP relays this data to FDA using an
location of goods. FDA stopped using efficiently obtain and process the electronic interface, the majority of data
these paper forms effective October 1, information it requires to fulfill its submitted by the entry filer need be
1995, to eliminate duplication of regulatory responsibility. done only once.
information and to reduce the Most of the information FDA requires
to carry out its regulatory FDA estimates the additional annual
paperwork burden both on the import
community and FDA. The Agency then responsibilities under section 801 of the burden for the information collection as
developed and implemented an FD&C Act is already provided a result of this rule as follows:

Number of Average burden per
Number of Total annual
Activity responses per response Total hours
respondents responses
Importers of Cigars who are Considered Manufac- 216 159 34,344 0.14 (81⁄2 minutes) 4,808
turers.
Importers of Pipe and Waterpipe Tobacco Who 43 123 5,289 0.14 (81⁄2 minutes) 740
Are Considered Manufacturers.
Importers Other Tobacco, E-Cigarettes, and Nico- 14 68 952 0.14 (81⁄2 minutes) 133
tine Product Manufacturers (ENDS).
Total Hours Importation of Tobacco Products ........................ ........................ ........................ .................................... 5,681
FDA estimates the burden hours to be same time they file entries electronically drugs, foods, cosmetics, and tobacco
5,681 burden hours (4,808 + 740 + 133 with CBP. products that may not be sold in the
hours). This reflects the addition of the United States to maintain records
6. Exports: Notification and
newly deemed tobacco products to the demonstrating their compliance with
Recordkeeping Requirements (OMB
list of FDA’s regulated products. When Control Number 0910–0482) the requirements in section 801(e)(1) of
testing the use of electronic and paper the FD&C Act. Section 801(e)(1) requires
forms, FDA determined that the average Description of Respondents: exporters to keep records demonstrating
time for completing either electronic or Respondents are manufacturers, that the exported product: (1) Meets
manual entries was the same. distributors, and other persons who with the foreign purchaser’s
export tobacco products not intended specifications; (2) does not conflict with
Based on the original data collected
for sale in the United States. the laws of the foreign country; (3) is
by FDA when the importer entry notice In a rule published on February 2,
information collection was most labeled on the outside of the shipping
2012 (77 FR 5171), FDA amended
recently approved, it is expected that package that is intended for export; and
certain of its general regulations to
each respondent will take 0.14 hour (81⁄2 (4) is not sold or offered for sale in the
include tobacco products, where
minutes) to respond. The estimated United States. These criteria also could
appropriate, in light of FDA’s authority
hours per response are expected to be met by maintaining other
to regulate these products under the
remain the same for tobacco importers. documentation, such as letters from a
Tobacco Control Act (conforming
FDA estimates that there will be no foreign government agency or notarized
amendments rule). The conforming
additional costs to provide import data certifications from a responsible
amendments rule subjects tobacco
electronically to FDA, as filers already company official in the United States
products to the same general
have equipment and software in place to requirements that apply to other FDA- stating that the exported product does
enable them to provide data to CBP via regulated products, where appropriate. not conflict with the laws of the foreign
the automated system. Therefore, no The conforming amendments rule country.
additional software or hardware need be amended 21 CFR 1.101(b), among other FDA estimates the annual burden for
developed or purchased to enable filers sections, to require persons who export the information collection as a result of
to file the FDA data elements at the human drugs, biologics, devices, animal this rule as follows:
TABLE 12—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2

Average burden
Number of Number of records Total annual
Activity per recordkeeping Total hours
recordkeepers per recordkeeper records (in hours)
21 CFR 1.101(b):
Cigar Manufacturers (Large and Small) 57 3 171 22 3,762

Pipe and Waterpipe Tobacco Manufac-
turers .................................................. 37 3 111 22 2,442
Other Tobacco, E-Cigarettes, and Nico-
tine Product Manufacturers (ENDS) .. 93 3 279 22 6,138
TABLE 12—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2—Continued

Average burden
Number of Number of records Total annual
Activity per recordkeeping Total hours
recordkeepers per recordkeeper records (in hours)
Exports: Notification and Record-

keeping Requirements ................ .............................. .............................. .............................. .............................. 12,342
2 Atpublication of the NPRM, the burden for these activities were under OMB control number 0910–0690. The burden has since been trans-
ferred to OMB control number 0910–0482.
The Agency has estimated the number hours per recordkeeper to maintain each information on how a manufacturer may
of respondents and burden hours record. The Agency estimates 12,342 demonstrate that a tobacco product was
associated with the recordkeeping burden hours will be needed for tobacco commercially marketed in the United
requirements by reviewing Agency product exporters to create and States on February 15, 2007, and is,
records and using Agency expert maintain records demonstrating therefore, a grandfathered product not
resources who have experience and compliance with section 801(e)(1) of the subject to premarket review. The
information regarding tobacco product FD&C Act. guidance recommends that the
exporters. FDA estimates that 187 7. Establishing That a Tobacco Product manufacturer provide evidence that may
establishments (50 percent of all the Was Commercially Marketed in the include, among other things, dated
tobacco manufacturers listed in the United States as of February 15, 2007 copies of advertisements, dated catalog
collection of information under OMB (OMB Control Number 0910–0775) pages, dated promotional material, and
Control Number 0910–0046 in this dated bills of lading. FDA recommends
Description of Respondents: that the manufacturer submit adequate
document who manufacture cigars, pipe Respondents to this collection of
tobacco, waterpipe, other tobacco information to demonstrate that the
information are manufacturers of tobacco product was commercially
products, and ENDS) could be involved tobacco products who wish to
in the exporting of all tobacco products marketed in the United States on
demonstrate that their tobacco product February 15, 2007.
annually. Based on previous was commercially marketed in the
recordkeeping estimates for the United States on February 15, 2007, and The estimate for the number of hours
exporter’s reporting burden in the is a grandfathered product not subject to in the existing collection is FDA’s
existing OMB-approved collection of premarket review. estimate of how long it might take one
information (OMB Control Number On September 29, 2014, FDA to review, gather, and submit dated
0910–0482, ‘‘Export Notification and published the guidance document information if making a request for an
Recordkeeping Requirements’’), each entitled ‘‘Establishing That a Tobacco Agency determination.
establishment will maintain an average Product Was Commercially Marketed in FDA estimates the annual burden for
of three records per year, and it will take the United States as of February 15, the information collection as a result of
each recordkeeper an average of 22 2007’’. This guidance provides this rule as follows:
TABLE 13—ESTIMATED ANNUAL REPORTING BURDEN 1 2

Average
Number of
Cigar Manufacturers (including large and small cigars and

importers) ......................................................................... 1 1 1 5 5
Pipe Tobacco Manufacturers (Including Importers) ............ 1 1 1 5 5
facturers (Including Importers) ......................................... 1 1 1 5 5
Total Hours Establishing that a Tobacco Product was

Commercially Marketed in the United States as of
February 15, 2007 ..................................................... ........................ ........................ ........................ ........................ 15
1 Thereare no capital costs or operating and maintenance costs associated with this collection of information.
2 At publication of the NPRM, this collection was not yet approved by OMB. On September 8, 2014, OMB approved the information collection
for 3 years.
Based on FDA’s experiences to date, manufacturer approximately 5 hours to that have been previously made
and given that stand-alone grandfather complete and submit for FDA review available for public comment because
submissions are purely voluntary, FDA the evidence required by this collection they involved tobacco products
does not anticipate that many of information for a total of 15 hours. currently subject to chapter IX of the
manufacturers will make such C. Burdens Associated With Tobacco FD&C Act. However, these information
submissions, but this option is Products Currently Subject to the FD&C collections have not yet been approved
available. As such, we assigned one Act But Not Yet Approved by OMB by OMB.
respondent annually per type of product
The information collections described
FDA estimates it will take a
in this section also involve collections
FDA based the estimates on the the United States after February 15, request for a meeting should be sent in
existing collections that were previously 2007. An order under section writing to the Director of CTP’s OS and
made available for comment. 910(c)(1)(A)(i) of the FD&C Act is should include adequate information for
• Applications for Premarket Review required prior to marketing a new FDA to assess the potential utility of the
of New Tobacco Products tobacco product. This requirement meeting and to identify FDA staff
Description of Respondents: The applies unless the product has been necessary to discuss agenda items. FDA
respondents to this collection of shown to be substantially equivalent to is required to deny a PMTA and issue
information are manufacturers who seek a valid predicate product or is exempt an order that the product may not be
a marketing authorization order under from SE. introduced or delivered for introduction
section 910(c)(1)(A)(i) of the FD&C Act. Section 910(b) of the FD&C Act states into interstate commerce under section
On September 28, 2011, FDA that a PMTA shall contain full reports 910(c)(1)(A)(ii) of the FD&C Act if FDA
announced the availability of a draft of all investigations of health risks; a finds that:
guidance entitled ‘‘Applications for full statement of all components, • The manufacturer has not shown
Premarket Review of New Tobacco ingredients, additives, and properties, that the product is appropriate for the
Products’’. This guidance, when and of the principle or principles of protection of the public health,
finalized, will represent the Agency’s operation of such tobacco product; a full • the manufacturing, processing, or
current thinking on the topic. Section description of methods of packing methods, facilities, or controls
910(a)(1) of the FD&C Act defines a manufacturing and processing (which do not conform to good manufacturing
‘‘new tobacco product’’ as a tobacco includes; a listing of all manufacturing, practices issued under section 906(e) of
product that was not commercially packaging, and control sites for the the FD&C Act,
marketed in the United States on product); an explanation of how the • the labeling is false or misleading in
February 15, 2007, or modification product complies with applicable any particular, or
(including a change in design, any tobacco product standards; samples of • the manufacturer has not shown
component, any part, or any constituent, the product and its components; and that the product complies with any
including a smoke constituent, or in the labeling. tobacco product standard in effect under
content, delivery or form of nicotine, or FDA also encourages persons who section 907 of the FD&C Act.
any other additive or ingredient) of a would like to study their new tobacco FDA estimates the annual burden for
tobacco product where the modified product to meet with the OS in CTP to the information collection as a result of
product was commercially marketed in discuss their investigational plan. The this rule as follows:

Average
Number of
Obtaining an FDA Order Authorizing Marketing of Tobacco Product (the application) and § 25.40 Environmental Assessments:

facturers (ENDS Liquids and ENDS Delivery Systems
(Including Importers)) ....................................................... 200 3.75 750 1,713 1,284,750
Total Hours Obtaining an FDA Order Authorizing Mar-
keting of Tobacco Product (the application) ............. ........................ ........................ ........................ ........................ 1,284,750
Request for Meeting with CTP’s Office of Science to Discuss Investigational Plan:

facturers (ENDS Liquids and ENDS Delivery Systems
(Including Importers)) ....................................................... 200 1 200 4 800
Total Hours Request for Meeting with CTP’s Office of
Science to Discuss Investigational Plan ................... ........................ ........................ ........................ ........................ 800
Total Hours ‘‘Applications for Premarket Review
of New Tobacco Products’’ ................................ ........................ ........................ ........................ ........................ 1,285,550
FDA estimates that it will take each some requiring more hours (e.g., as responses for ENDS manufacturers. We
respondent approximately 1,500 hours many as 5,000 hours for early attribute this increase to the rapid
to prepare a PMTA seeking an order applications that involve complex growing ENDS market since the NPRM
from FDA allowing the marketing of a products and for which the company was published. FDA’s estimate includes
new tobacco product. FDA also has no experience conducting studies or anticipated burden for the writing of an
estimates that it would on average take preparing analysis of public health application, including intracompany
an additional 213 hours to prepare an impacts, or for which reliance on master edits and approvals. FDA also estimates
environmental assessment in files is not possible) as well as many the number of PMTAs that FDA expects
accordance with the requirements of requiring fewer hours (e.g., as few as 50 to receive annually will be 750 (642
§ 25.40, for a total of 1,713 hours per hours for applications for products that ENDS Liquids and 108 ENDS Delivery
PMTA application. This average are very similar to other new products). Systems).
represents a wide range of hours that Although FDA has decreased the We are clarifying here that a PMTA
will be required for these applications burden per each PMTA, we have may require one or more types of
under different circumstances, with increased the number of expected studies including chemical analysis,
nonclinical studies, and clinical studies. FDA anticipates that the 200 potential include the warning statement in
FDA expects that chemical and design respondents to this collection may need § 1143.3(a)(1). Section1143.3(c) will
parameter analysis would include the to meet with CTP’s Office of Science to provide an exemption to the
testing of applicable HPHCs and discuss their investigational plans. To manufacturer of a product that
nonclinical analysis would include request this meeting, applicants should otherwise would be required to include
literature synthesis and, as appropriate, compile and submit information to FDA the warning statement in § 1143.3(a)(1)
some combination of in vitro or in vivo for meeting approval. FDA estimates on its packages and in its
studies, and computational analyses. that it will take approximately 4 hours advertisements, i.e., ‘‘WARNING: This
For the clinical study component, one to compile this information, for a total product contains nicotine. Nicotine is
or more types of studies may be of 800 hours additional burden (200 an addictive chemical.’’ This warning
included to address, as needed, respondents × 4 hours). will be required to appear on at least 30
perception, use pattern, or health Therefore, the total annual burden for percent of the two principal display
impact. It is possible that an applicant submitting PMTA applications is panels of the package and on at least 20
may not need to conduct any new estimated to be 1,285,550 hours. FDA’s percent of the area of the advertisement.
nonclinical or clinical studies. We note estimates are based on the
that for most applications, FDA does not corresponding information collection To obtain an exemption from this
expect that applicants will include estimates that apply to tobacco products requirement, a manufacturer would be
randomized clinical trials, like those currently subject to the FD&C Act and required to certify to FDA that its
conducted to support drug and device an assumption that manufacturers product does not contain nicotine and
approvals. would submit applications for the that the manufacturer has data to
For tobacco products already on the premarket review of tobacco products. support that assertion. For any product
market at the time of the final rule, that obtains this exemption, the section
much of the information required to D. New Collections of Information That requires that the product bear the
support a PMTA may be obtained from Apply Only to Deemed Tobacco statement: ‘‘This product is made from
previously published research on Products tobacco.’’ The parties that package and
similar products. Therefore, FDA 1. Exemption From the Required label such products will share
expects that a large portion of Warning Statement Requirement responsibility for ensuring that this
applications may be reviewed with no alternative statement is included on
or minimal new nonclinical or clinical Description of Respondents:
Respondents are manufacturers who, to product packages and in
studies being conducted to support an
obtain an exemption from the required advertisements. The rule will permit
application. In contrast, nonclinical and
addictiveness warning, certify to FDA companies to obtain an exemption from
clinical studies may be required for
that their product does not contain this warning requirement in the event
market authorization of a new product
for which there is limited understanding nicotine and that the manufacturer has that such tobacco products are
of its potential impact on the public data to support that assertion. developed in the future.
health. The range of hours involved to This rule contains a new information FDA estimates the annual burden for
compile these two types of applications collection that pertains to an exemption the information collection as a result of
would be quite variable. process related to the requirement to this rule as follows:

Average
Number of
Certification Statement ......................................................... 1 1 1 20 20
Total Exemptions From the Required Warning State-

ment Requirement ..................................................... ........................ ........................ ........................ ........................ 20
The estimated average burden per request. FDA expects that these types of the purpose of ‘‘disclosure to the
response is based on information certifications will be very rare and public’’ (5 CFR 1320.3(c)(2)).
collection estimates that apply to estimates that the Agency will receive 2. Submitting Warning Plans for Cigar
tobacco products currently subject to on average one submission per year. Manufacturers, Importers, Distributors,
the FD&C Act. Although very few FDA concludes that the labeling and Retailers
certifications are expected for tobacco
statements in §§ 1143.3(a)(1) and
products that do not contain nicotine, Description of Respondents: The
1143.5(a)(1) and the alternative respondents to this collection of
FDA estimates that the number of
certification submissions could rise if statement in § 1143.3(c) (i.e., ‘‘This information are manufacturers,
the Agency decides in the future to product is made from tobacco’’) are not importers, distributors, and retailers of
address not only nicotine, but any other subject to review by OMB because they cigar products who will be required to
addictive substances. do not constitute a ‘‘collection of submit warning plans for cigars to FDA.
The estimated hours listed in the information’’ under the PRA (44 U.S.C. The requirement for submission of
burden table for certification 3501–3520). Rather, these labeling warning plans for cigar products, and
submissions reflect the time needed to statements are a ‘‘public disclosure’’ of the specific requirements relating to the
test the product for nicotine and to information originally supplied by the random display and distribution of
prepare and submit the self-certification Federal Government to the recipient for required warning statements on cigar
packaging and quarterly rotation of submitters to ensure that the plans packaging are not required to submit a
required warning statements in submitted meet the established criteria warning plan for warnings on packages,
alternating sequence on cigar product for approval under part 1143. FDA also because the warning signs posted at a
advertising, appear in § 1143.5(c). intends to update the warning plan draft retailer’s point-of-sale would include all
The six warnings for cigars (five guidance and information collection, six warnings applicable to cigars, as we
specifically for cigars and the one which currently pertains to smokeless have noted in § 1143.5(c)(1). Therefore,
addictiveness warning) will be required tobacco products, to assist it is not necessary to submit a rotational
to be randomly displayed in each 12- manufacturers, importers, distributors, warning plan for them. However,
month period, in as equal a number of and retailers of cigars with the manufacturers, distributors, and those
times as is possible on each brand of submission of warning plans. The retailers who are responsible for or
cigar sold in product packaging and be information collection in this draft direct the health warning of the
randomly distributed in all areas of the guidance is approved under OMB advertisements of such products must
United States in which the product is Control Number 0910–0671. The draft submit a warning plan for their
marketed accordance with a warning guidance document discusses, among advertisements for FDA approval. The
plan submitted to and approved by other things: The statutory requirement rule requires them to include warnings
FDA. For advertisements, the warning to submit a warning plan; definitions; on advertisements, and the warnings
statements must be rotated quarterly in who submits a warning plan; the scope that must be rotated quarterly in
alternating sequence in each of a warning plan; when to submit a alternating sequence in each
advertisement for each brand of cigar in warning plan; what information should advertisement for each brand of cigar, in
accordance with a warning plan be submitted in a warning plan; where accordance with an FDA approved
submitted to and approved by FDA. to submit a warning plan; and what warning plan.
For cigar products that are on the approval of a warning plan means. FDA is also requiring that the
market as of the publication date of the The warning statements on cigar required warning statements be rotated
final rule, the effective date for the packaging must be randomly displayed quarterly in alternating sequence in
requirement to submit warning plans by in each 12-month period, in as equal a each advertisement for each brand of
responsible manufacturers, distributors, number of times as is possible on each cigar, regardless of whether the cigar is
importers, and retailers is 1 year after brand of cigar sold and are required to sold in product packaging. This rotation
the date of publication of the final rule. be randomly distributed in all areas of of warning statements in cigar
FDA is establishing this effective date 1 the United States in which the product advertisements also must be done in
year before the effective date of the is marketed in accordance with a accordance with a warning plan
remainder of the part 1143 requirements warning plan submitted by the submitted by the responsible cigar
because the Agency anticipates that responsible cigar manufacturer, manufacturer, importer, distributor, or
there will be a need for considerable importer, distributor, or retailer to and retailer to and approved by FDA.
communication with submitters during approved by FDA. FDA estimates the annual burden for
its review of the warning plan To clarify, retailers of cigars sold the information collection as a result of
submissions. FDA will work with the individually and not in product this rule as follows:

Average
Number of
Cigar warning plan responses per Total hours
Manufacturers, Importers, and Retailers ............................. 329 1 329 120 39,480
Total Cigar Warning Plan ............................................. 39,480

The burden estimates are based on ‘‘small-scale tobacco product and to consider any and all relevant
FDA’s experience with smokeless manufacturers.’’ facts in determining whether to bring an
warning plans and the associated As discussed in section IV, FDA enforcement action.
information collection (OMB Control requested comment on the ability of Generally, FDA considers a ‘‘small-
Number 0910–0671) as well as warning smaller manufacturers of newly deemed scale tobacco product manufacturer’’ to
plans for cigarettes submitted to the FTC tobacco products to fully comply with be a manufacturer of any regulated
prior to the implementation of the the requirements of the FD&C Act and tobacco product that employs 150 or
Tobacco Control Act on June 22, 2009. how FDA might be able to address those fewer full-time equivalent employees
We estimate 329 entities will submit concerns. Considering the comments and has annual total revenues of
warning plans, and it will take an and FDA’s finite enforcement resources, $5,000,000 or less. FDA considers a
average of 120 hours per respondent to the Agency’s view is that those manufacturer to include each entity that
prepare and submit a warning plan for resources may not be best used in it controls, is controlled by, or is under
packaging and advertising for a total of immediately enforcing the provisions of common control with such
39,480 hours. this rule against certain manufacturers manufacturer. To help make FDA’s
3. Small-Scale Manufacturer Report that are small-scale tobacco product individual enforcement decisions more
manufacturers and that fail to comply efficient, a manufacturer may
Description of Respondents: The with certain requirements of the FD&C voluntarily submit information
respondents to this collection of Act. FDA retains discretion in all cases regarding employment and revenues.
information are manufacturers known as to conduct an individualized inquiry FDA does not believe a large number of
manufacturers who fit the criteria of a manufacturers who will voluntarily FDA has estimated the burden for
small-scale tobacco product submit information. FDA believes it will submitting the ‘‘small-scale tobacco
manufacturer would submit the take respondents 2 hours to voluntarily product manufacturer’’ annual report as
voluntary information. submit information regarding follows:
FDA estimates that there are employment and revenues for a total of
approximately 75 small-scale 150 hours.

Average
Number of
Small-Scale Manufacturer Reporting ................................... 75 1 75 2 150
Total Small-Scale Manufacturer Report ....................... 150

The total burden for these new consultation with tribes via Webinar training and funding opportunities to
collections of information in this regarding the NPRM on May 29, 2014. tribal governments to alleviate the
rulemaking is 1,621,212 reporting hours FDA received one comment from a tribe economic burdens stemming from
(121,604 + 1,200 + 9,363 + 158,149 + stating that FDA failed to ensure enforcement of the rule. The comment
5,681 + 15 + 1,285,550 + 20 + 39,480 + meaningful and timely input from tribal urged FDA to make certain the
150) and 12,342 recordkeeping hours for officials as required by Executive Order regulatory burdens do not limit the
a total of 1,633,554 burden hours. 13175 and requesting tribal consultation economic viability of tribal operations.
The information collection provisions in relation to existing premarket review (Response) FDA recognizes tribal
in this final rule have been submitted to activities for cigarettes, roll-your-own sovereignty and tribal self-regulation
OMB for review as required by section tobacco, and smokeless tobacco. In and will work in partnership with tribal
3507(d) of the Paperwork Reduction Act response, FDA conducted a face-to-face leaders to monitor compliance with this
of 1995. meeting with the tribe regarding the rule. As explained in this rule, FDA is
Before the effective date of this final NPRM on January 21, 2015. FDA has implementing this rule to protect public
rule, FDA will publish a notice in the determined that this final rule does not health. However, FDA recognizes that
Federal Register announcing OMB’s have tribal implications under compliance with many of the automatic
decision to approve, modify, or Executive Order 13175, because it does provisions may be challenging at first
disapprove the information collection not, to our knowledge, have a for entities that are new to Federal
provisions in this final rule. An Agency substantial direct effect on one or more public health regulation and as a result,
may not conduct or sponsor, and a Indian tribes, on the relationship provided compliance policies relating to
person is not required to respond to, a between the Federal Government and provisions such as premarket
collection of information unless it Indian tribes, or on the distribution of authorizations and provided additional
displays a currently valid OMB control power and responsibilities between the time to comply with certain
number. Federal Government and Indian tribes, requirements of the FD&C Act for small-
nor does it impose substantial direct scale tobacco manufacturers. FDA will
XX. Executive Order 13132; Federalism
compliance costs. provide training and other opportunities
FDA has analyzed this final rule in (Comment 305) One comment stated to tribal governments after the rule is
accordance with the principles set forth that FDA failed to ensure meaningful finalized.
in Executive Order 13132. FDA has and timely input from tribal officials as
determined that the rule does not required by Executive Order 13175 and XXII. References
contain policies that have substantial the HHS Consultation Policy. The The following references are on
direct effects on the States, on the comment acknowledged FDA’s ‘‘Dear display in the Division of Dockets
relationship between the National Tribal Leader’’ letter and Webinar and Management (see ADDRESSES) and are
Government and the States, or on the requested a face-to-face meeting available for viewing by interested
distribution of power and between FDA and its tribe in relation to persons between 9 a.m. and 4 p.m.
responsibilities among the various existing premarket review activities for Monday through Friday; they are also
levels of government. Accordingly, the cigarettes, roll-your-own tobacco, and available electronically at http://
Agency has concluded that the rule does smokeless tobacco. www.regulations.gov. FDA has verified
not contain policies that have (Response) FDA adheres to Executive the Web site addresses, as of the date
federalism implications as defined in Order 13175 and the HHS Consultation this document publishes in the Federal
the Executive Order and, consequently, Policy. FDA is committed to meaningful Register, but Web sites are subject to
a federalism summary impact statement consultation with federally recognized change over time.
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of covered tobacco products, and to For the purposes of this part: Pub. L. 111–31, 123 Stat. 1776.
require the use of health warning
statements for cigarette tobacco, roll- Accessory means any product that is ■ 3. Revise the heading to part 1140 as
your-own tobacco, and covered tobacco intended or reasonably expected to be set forth above.
products. used with or for the human ■ 4. Revise § 1140.1 to read as follows:
279. Finding of No Significant Impact for consumption of a tobacco product; does
Regulations (21 CFR 1100, 1140, and not contain tobacco and is not made or § 1140.1 Scope.
1143) to deem tobacco products meeting derived from tobacco; and meets either (a) This part sets out the restrictions
the statutory definition of ‘‘tobacco of the following: under the Federal Food, Drug, and
product’’ to be subject to the Federal
Food, Drug, and Cosmetic Act, to revise (1) Is not intended or reasonably Cosmetic Act on the sale, distribution,
existing regulations to include expected to affect or alter the and use of cigarettes, smokeless tobacco,
restrictions on the sale and distribution performance, composition, constituents, and covered tobacco products. Section
of covered tobacco products, and to or characteristics of a tobacco product; 1140.16(d) sets out restrictions on the
require the use of health warning or distribution of free samples for
statements for cigarette tobacco, roll- (2) Is intended or reasonably expected cigarettes, smokeless tobacco, and other
your-own tobacco, and covered tobacco to affect or maintain the performance, tobacco products (as such term is
products.
composition, constituents, or defined in section 201 of the Federal
List of Subjects characteristics of a tobacco product but Food, Drug, and Cosmetic Act).
(i) Solely controls moisture and/or (b) The failure to comply with any
21 CFR Part 1100
temperature of a stored tobacco product; applicable provision in this part in the
Smoking, Tobacco. or sale, distribution, and use of cigarettes,
21 CFR Part 1140 (ii) Solely provides an external heat smokeless tobacco, covered tobacco
source to initiate but not maintain products, or other tobacco products
Advertising, Labeling, Smoking, renders the product misbranded under
combustion of a tobacco product.
Tobacco. the Federal Food, Drug, and Cosmetic
Component or part means any
21 CFR Part 1143 software or assembly of materials Act.
Advertising, Labeling, Packaging and intended or reasonably expected: (c) References in this part to
containers, Smoking, Tobacco. (1) To alter or affect the tobacco regulatory sections of the Code of
product’s performance, composition, Federal Regulations are to chapter I of
Therefore, under the Federal Food,
constituents, or characteristics; or title 21, unless otherwise noted.
Drug, and Cosmetic Act and under
authority delegated to the Commissioner (2) To be used with or for the human ■ 5. Revise § 1140.2 to read as follows:
of Food and Drugs, 21 CFR chapter I is consumption of a tobacco product.
§ 1140.2 Purpose.
amended as follows: Component or part excludes anything
that is an accessory of a tobacco The purpose of this part is to establish
■ 1. Add part 1100 to subchapter K to
product. restrictions on the sale, distribution, and
read as follows: use of cigarettes, smokeless tobacco, and
Package or packaging means a pack,
PART 1100—TOBACCO PRODUCTS box, carton, or container of any kind or, covered tobacco products in order to
SUBJECT TO FDA AUTHORITY if no other container, any wrapping reduce the number of children and
(including cellophane), in which a adolescents who use these products,
Sec. tobacco product is offered for sale, sold, and to reduce the life-threatening
1100.1 Scope. consequences associated with tobacco
1100.2 Requirements.
or otherwise distributed to consumers.
Tobacco product. As stated in section use.
1100.3 Definitions.
201(rr) of the Federal Food, Drug, and ■ 6. Revise § 1140.3 to read as follows:
Authority: 21 U.S.C. 387a(b), 387f(d) and
Pub. L. 111–31.
Cosmetic Act in relevant part, a tobacco
§ 1140.3 Definitions.
product:
§ 1100.1 Scope. (1) Means any product made or For the purposes of this part:
In addition to FDA’s authority over derived from tobacco that is intended Accessory means any product that is
cigarettes, cigarette tobacco, roll-your- for human consumption, including any intended or reasonably expected to be
own tobacco, and smokeless tobacco, component, part, or accessory of a used with or for the human
FDA deems all other products meeting tobacco product (except for raw consumption of a tobacco product; does
the definition of tobacco product under materials other than tobacco used in not contain tobacco and is not made or
section 201(rr) of the Federal Food, manufacturing a component, part, or derived from tobacco; and meets either
Drug, and Cosmetic Act, except accessory of a tobacco product); and of the following:
accessories of such other tobacco (2) Does not mean an article that is a (1) Is not intended or reasonably
products, to be subject to the Federal drug under section 201(g)(1) of the expected to affect or alter the
Food, Drug, and Cosmetic Act. Federal Food, Drug, and Cosmetic Act, performance, composition, constituents,
a device under section 201(h) of the or characteristics of a tobacco product;
§ 1100.2 Requirements.
Federal Food, Drug, and Cosmetic Act, or
Cigarettes, cigarette tobacco, roll-your- or a combination product described in (2) Is intended or reasonably expected
own tobacco, smokeless tobacco are section 503(g) of the Federal Food, Drug, to affect or maintain the performance,
subject to chapter IX of the Federal and Cosmetic Act. composition, constituents, or

Food, Drug, and Cosmetic Act and its characteristics of a tobacco product but
implementing regulations. FDA has PART 1140—CIGARETTES, (i) Solely controls moisture and/or
deemed all other tobacco products, SMOKELESS TOBACCO, AND temperature of a stored product; or
except accessories of such other tobacco COVERED TOBACCO PRODUCTS (ii) Solely provides an external heat
products, subject to chapter IX of the source to initiate but not maintain
Federal Food, Drug, and Cosmetic Act ■ 2. The authority citation for 21 CFR combustion of a tobacco product.
and its implementing regulations. part 1140 continues to read as follows: Cigarette. (1) Means a product that:
(i) Is a tobacco product and otherwise obtain tobacco products for identification containing the bearer’s
(ii) Meets the definition of the term personal consumption. date of birth that no person purchasing
‘‘cigarette’’ in section 3(1) of the Federal Retailer means any person who sells the product is younger than 18 years of
Cigarette Labeling and Advertising Act; tobacco products to individuals for age;
and personal consumption, or who operates (ii) No such verification is required
(2) Includes tobacco, in any form, that a facility where vending machines or for any person over the age of 26;
is functional in the product, which, self-service displays are permitted (3) Except as otherwise provided in
because of its appearance, the type of under this part. § 1140.16(c)(2)(ii), a retailer may sell
tobacco used in the filler, or its Roll-your-own tobacco means any cigarettes or smokeless tobacco only in
packaging and labeling, is likely to be tobacco product that, because of its a direct, face-to-face exchange without
offered to, or purchased by, consumers appearance, type, packaging, or labeling, the assistance of any electronic or
as a cigarette or as roll-your-own is suitable for use and likely to be mechanical device (such as a vending
tobacco. offered to, or purchased by, consumers machine);
Cigarette tobacco means any product as tobacco for making cigarettes. (4) No retailer may break or otherwise
that consists of loose tobacco that is Smokeless tobacco means any tobacco open any cigarette or smokeless tobacco
intended for use by consumers in a product that consists of cut, ground, package to sell or distribute individual
cigarette. Unless otherwise stated, the powdered, or leaf tobacco and that is cigarettes or a number of unpackaged
requirements applicable to cigarettes intended to be placed in the oral or cigarettes that is smaller than the
under this chapter also apply to nasal cavity. quantity in the minimum cigarette
cigarette tobacco. Tobacco product. As stated in section package size defined in § 1140.16(b), or
Component or part means any 201(rr) of the Federal Food, Drug, and any quantity of cigarette tobacco or
software or assembly of materials Cosmetic Act in relevant part, a tobacco smokeless tobacco that is smaller than
intended or reasonably expected: product: the smallest package distributed by the
(1) To alter or affect the tobacco (1) Means any product made or manufacturer for individual consumer
product’s performance, composition, derived from tobacco that is intended use; and
constituents, or characteristics; or for human consumption, including any (5) Each retailer must ensure that all
(2) To be used with or for the human component, part, or accessory of a self-service displays, advertising,
consumption of a tobacco product. tobacco product (except for raw labeling, and other items, that are
Component or part excludes anything materials other than tobacco used in located in the retailer’s establishment
that is an accessory of a tobacco manufacturing a component, part, or and that do not comply with the
product. accessory of a tobacco product) and requirements of this part, are removed
Covered tobacco product means any (2) Does not mean an article that is a or are brought into compliance with the
tobacco product deemed to be subject to drug under section 201(g)(1) of the requirements under this part.
the Federal Food, Drug, and Cosmetic Federal Food, Drug, and Cosmetic Act, (b) Notwithstanding the requirements
Act under § 1100.2 of this chapter, but a device under section 201(h) of the in paragraph (a) of this section and in
excludes any component or part that is Federal Food, Drug, and Cosmetic Act, addition to the other requirements
not made or derived from tobacco. or a combination product described in under this part, each retailer of covered
section 503(g) of the Federal Food, Drug, tobacco products is responsible for
Distributor means any person who
and Cosmetic Act. ensuring that all sales of such covered
furthers the distribution of a tobacco
product, whether domestic or imported, ■ 7. Revise § 1140.10 to read as follows: tobacco products to any person comply
at any point from the original place of with the following requirements:
§ 1140.10 General responsibilities of (1) No retailer may sell covered
manufacture to the person who sells or manufacturers, distributors, and retailers.
distributes the product to individuals tobacco products to any person younger
Each manufacturer, distributor, than 18 years of age;
for personal consumption. Common importer, and retailer is responsible for
carriers are not considered distributors (2)(i) Except as otherwise provided in
ensuring that the cigarettes, smokeless paragraph (a)(2)(ii) of this section and in
for the purposes of this part. tobacco, or covered tobacco products it
Importer means any person who § 1140.16(c)(2)(i), each retailer must
manufactures, labels, advertises, verify by means of photographic
imports any tobacco product that is packages, distributes, imports, sells, or
intended for sale or distribution to identification containing the bearer’s
otherwise holds for sale comply with all date of birth that no person purchasing
consumers in the United States. applicable requirements under this part.
Manufacturer means any person, the product is younger than 18 years of
■ 8. Revise § 1140.14 to read as follows: age;
including any repacker and/or relabeler,
(ii) No such verification is required
who manufactures, fabricates, § 1140.14 Additional responsibilities of
for any person over the age of 26; and
assembles, processes, or labels a retailers.
(3) A retailer may not sell covered
finished tobacco product. (a) In addition to the other tobacco products with the assistance of
Nicotine means the chemical requirements under this part, each any electronic or mechanical device
substance named 3-(1-Methyl-2- cigarette and smokeless tobacco retailer (such as a vending machine), except in
pyrrolidinyl)pyridine or C[10]H[14]N[2], is responsible for ensuring that all sales facilities where the retailer ensures that
including any salt or complex of of cigarettes or smokeless tobacco to any no person younger than 18 years of age
nicotine. person comply with the following is present, or permitted to enter, at any
Package or packaging means a pack, requirements: time.

box, carton, or container of any kind or, (1) No retailer may sell cigarettes or
■ 9. Add part 1143 to subchapter K to
if no other container, any wrapping smokeless tobacco to any person
(including cellophane) in which a younger than 18 years of age; read as follows:
tobacco product is offered for sale, sold, (2)(i) Except as otherwise provided in PART 1143—MINIMUM REQUIRED
or otherwise distributed to consumers. paragraph (a)(2)(ii) of this section and in WARNING STATEMENTS
Point of sale means any location at § 1140.16(c)(2)(i), each retailer must
which a consumer can purchase or verify by means of photographic Sec.
1143.1 Definitions. (including cellophane), in which a (i) Be located in a conspicuous and

1143.3 Required warning statement tobacco product is offered for sale, sold, prominent place on the two principal
regarding addictiveness of nicotine. or otherwise distributed to consumers. display panels of the package and the
1143.5 Required warning statements for Principal display panels means the warning area must comprise at least 30
cigars.
1143.7 Language requirements for required
panels of a package that are most likely percent of each of the principal display
warning statements. to be displayed, presented, shown, or panels;
1143.9 Irremovable or permanent required examined by the consumer. (ii) Be printed in at least 12-point font
warning statements. Point of sale means any location at size and ensures that the required
1143.11 Does not apply to foreign which a consumer can purchase or warning statement occupies the greatest
distribution. otherwise obtain tobacco products for possible proportion of the warning area
1143.13 Effective date. personal consumption. set aside for the required text;
Authority: 21 U.S.C. 387a(b), 387f(d). Retailer means any person who sells (iii) Be printed in conspicuous and
tobacco products to individuals for legible Helvetica bold or Arial bold type
§ 1143.1 Definitions. personal consumption, or who operates (or other sans serif fonts) and in black
For purposes of this part: a facility where vending machines or text on a white background or white text
Accessory means any product that is self-service displays are permitted on a black background in a manner that
intended or reasonably expected to be under this part. contrasts by typography, layout, or
used with or for the human Required warning statement means a color, with all other printed material on
consumption of a tobacco product; does textual warning statement required to be the package;
not contain tobacco and is not made or on packaging and in advertisements for (iv) Be capitalized and punctuated as
derived from tobacco; and meets either cigarette tobacco, roll-your-own tobacco, indicated in paragraph (a)(1) of this
of the following: cigars, and other covered tobacco section; and
(1) Is not intended or reasonably products. (v) Be centered in the warning area in
expected to affect or alter the Roll-your-own tobacco means any which the text is required to be printed
performance, composition, constituents, tobacco product that, because of its and positioned such that the text of the
or characteristics of a tobacco product; appearance, type, packaging, or labeling, required warning statement and the
or is suitable for use and likely to be other information on the principal
(2) Is intended or reasonably expected offered to, or purchased by, consumers display panel have the same orientation.
to affect or maintain the performance, as tobacco for making cigarettes. (3) A retailer of any tobacco product
composition, constituents, or Tobacco product. As stated in section covered by paragraphs (a)(1) and (2) of
characteristics of a tobacco product but 201(rr) of the Federal Food, Drug, and this section will not be in violation of
(i) Solely controls moisture and/or Cosmetic Act in relevant part, a tobacco this section for packaging that:
temperature of a stored tobacco product; product: (i) Contains a health warning;
or (1) Means any product made or (ii) Is supplied to the retailer by the
(ii) Solely provides an external heat derived from tobacco that is intended tobacco product manufacturer, importer,
source to initiate but not maintain for human consumption, including any or distributor, who has the required
combustion of a tobacco product component, part, or accessory of a state, local, or Alcohol and Tobacco Tax
Cigar means a tobacco product that: tobacco product (except for raw and Trade Bureau (TTB)-issued license
(1) Is not a cigarette and materials other than tobacco used in or permit, if applicable, and
(2) Is a roll of tobacco wrapped in leaf manufacturing a component, part, or (iii) Is not altered by the retailer in a
tobacco or any substance containing accessory of a tobacco product) and way that is material to the requirements
tobacco. (2) Does not mean an article that is a of this section.
Cigarette tobacco means any product drug under section 201(g)(1) of the (b) Advertisements. (1) For cigarette
that consists of loose tobacco that is Federal Food, Drug, and Cosmetic Act, tobacco, roll-your-own tobacco, and
intended for use by consumers in a a device under section 201(h) of the covered tobacco products other than
cigarette. Unless otherwise stated, the Federal Food, Drug, and Cosmetic Act, cigars, it is unlawful for any such
requirements applicable to cigarettes or a combination product described in tobacco product manufacturer,
under this chapter also apply to section 503(g) of the Federal Food, Drug, packager, importer, distributor, or
cigarette tobacco. and Cosmetic Act. retailer of the tobacco product to
Component or part means any advertise or cause to be advertised
software or assembly of materials § 1143.3 Required warning statement within the United States any tobacco
intended or reasonably expected: regarding addictiveness of nicotine. product unless each advertisement bears
(1) To alter or affect the tobacco (a) Packages. (1) For cigarette tobacco, the required warning statement
product’s performance, composition, roll-your-own tobacco, and covered specified in paragraph (a)(1) of this
constituents, or characteristics; or tobacco products other than cigars, it is section.
(2) to be used with or for the human unlawful for any person to manufacture, (2) For print advertisements and other
consumption of a tobacco product. package, sell, offer to sell, distribute, or advertisements with a visual component
Component or part excludes anything import for sale or distribution within (including, for example, advertisements
that is an accessory of a tobacco the United States such product unless on signs, shelf-talkers, Internet Web
product. the tobacco product package bears the pages, and electronic mail
Covered tobacco product means any following required warning statement correspondence), the required warning
tobacco product deemed to be subject to on the package label: ‘‘WARNING: This statement must appear in the upper
the Federal Food, Drug, and Cosmetic product contains nicotine. Nicotine is portion of the area of the advertisement
Act pursuant to § 1100.2 of this chapter, an addictive chemical.’’ within the trim area as follows:
but excludes any component or part that (2) The required warning statement (i) Occupy at least 20 percent of the
is not made or derived from tobacco. must appear directly on the package and area of the advertisement;
Package or packaging means a pack, must be clearly visible underneath any (ii) Appear in at least 12-point font
box, carton, or container of any kind or, cellophane or other clear wrapping as size and ensures that the required
if no other container, any wrapping follows: warning statement occupies the greatest
possible proportion of the warning area outer container or wrapper if the carton, and positioned such that the text of the
set aside for the required text; outer container, or wrapper has required warning statement and the
(iii) Appear in conspicuous and sufficient space to bear the information, other information on that principal
legible Helvetica bold or Arial bold type or appear on a tag otherwise firmly and display panel have the same orientation.
(or other similar sans serif fonts) and in permanently affixed to the tobacco (3) No person may manufacture,
black text on a white background or product package. In such cases, the package, sell, offer to sell, distribute, or
white text on a black background in a carton, outer container, wrapper, or tag import for sale or distribution within
manner that contrasts by typography, will serve as the location of the the United States any cigar without a
layout, or color, with all other material principal display panels. required warning statement, except for
on the advertisement; cigars that are sold individually and not
(iv) Be capitalized and punctuated as § 1143.5 Required warning statements for in a product package. For cigars that are
indicated in paragraph (a)(1) of this cigars.
sold individually and not in a product
section; (a) Packages. (1) It is unlawful for any package, the required warning
(v) Be centered in the warning area in person to manufacture, package, sell, statements must be posted at the
which the text is required to appear and offer to sell, distribute, or import for sale retailer’s point-of-sale in accordance
positioned such that the text of the or distribution within the United States with the following:
required warning statement and the any cigar product unless the product (i) All of the warnings in paragraph (a)
other textual information in the package bears one of the following of this section must be placed on a sign
advertisement have the same required warning statements on the that is a minimum of 8.5 x 11 inches,
orientation; and package label: posted on or within 3 inches of each
(vi) Be surrounded by a rectangular (i) WARNING: Cigar smoking can cash register where payment may be
border that is the same color as the text cause cancers of the mouth and throat, made so that the sign(s) are
of the required warning statement and even if you do not inhale. unobstructed in their entirety and can
that is not less than 3 millimeters (mm) (ii) WARNING: Cigar smoking can be read easily by each consumer making
or more than 4 mm. cause lung cancer and heart disease. a purchase;
(3) This paragraph (b) applies to a (iii) WARNING: Cigars are not a safe (ii) The sign must be clear, legible,
retailer only if that retailer is alternative to cigarettes. and conspicuous and be printed in
responsible for or directs the health (iv) WARNING: Tobacco smoke black Helvetica bold or Arial bold type
warning required under the paragraph. increases the risk of lung cancer and (or other similar sans serif fonts) against
However, this paragraph does not heart disease, even in nonsmokers. a solid white background in at least 17
relieve a retailer of liability if the (v)(A) WARNING: Cigar use while point type with appropriate space
retailer displays, in a location open to pregnant can harm you and your baby.; between the warning statements;
the public, an advertisement that does or (iii) Be printed in a manner that
not contain a health warning or contains (B) SURGEON GENERAL WARNING: contrasts by typography, layout, or
a health warning that has been altered Tobacco Use Increases the Risk of color, with all other printed material;
by the retailer in a way that is material Infertility, Stillbirth and Low Birth and
to the requirements of this section. Weight. (iv) Be capitalized and punctuated as
(c) Self-certification. A tobacco (vi) WARNING: This product contains indicated in paragraph (a)(1) of this
product that would otherwise be nicotine. Nicotine is an addictive section.
required to bear the warning in chemical. (4) A retailer of any cigar covered by
paragraph (a)(1) of this section but does (2) Each required warning statement paragraphs (a)(1) and (2) of this section
not contain nicotine is not required to must appear directly on the package and will not be in violation of this section
bear the warning in paragraph (a)(1) of must be clearly visible underneath any for packaging that:
this section on packages or cellophane or other clear wrapping as (i) Contains a health warning;
advertisements if the tobacco product follows: (ii) Is supplied to the retailer by the
manufacturer has submitted to FDA a (i) Be located in a conspicuous and tobacco product manufacturer, importer,
confirmation statement certifying to be prominent place on the two principal or distributor who has the required
true and accurate that the product does display panels of the package and the state, local, or Alcohol and Tobacco Tax
not contain nicotine and that the warning area must comprise at least 30 and Trade Bureau (TTB)-issued license
tobacco product manufacturer has data percent of each of the principal display or permit, if applicable, and
to support that assertion. Any product panels; (iii) Is not altered by the retailer in a
not required to bear the warning in (ii) Appear in at least 12-point font way that is material to the requirements
paragraph (a)(1) of this section must size and ensure that the required of this section.
include the statement ‘‘This product is warning statement occupies the greatest (b) Advertisements. (1) It is unlawful
made from tobacco.’’ on all packages possible proportion of the warning area for any tobacco product manufacturer,
and advertisements in accordance with set aside for the required text; packager, importer, distributor, or
the requirements of this part. (iii) Be printed in conspicuous and retailer of cigars to advertise or cause to
(d) Small packages. A tobacco legible Helvetica bold or Arial bold type be advertised within the United States
product that would otherwise be (or other similar sans serif fonts) and in any cigar unless each advertisement
required to bear the warning in black text on a white background or bears one of the required warning
paragraph (a)(1) of this section but is too white text on a black background in a statements specified in paragraph (a)(1)
small or otherwise unable to manner that contrasts by typography, of this section.

accommodate a label with sufficient layout, or color, with all other printed (2) For print advertisements and other
space to bear such information is material on the package; advertisements with a visual component
exempt from compliance with the (iv) Be capitalized and punctuated as (including, for example, advertisements
requirement provided that the indicated in paragraph (a)(1) of this on signs, shelf-talkers, Internet Web
information and specifications required section; and pages, and electronic mail
under paragraphs (a)(1) and (2) of this (v) Be centered in the warning area in correspondence), each required warning
section appear on the carton or other which the text is required to be printed statement must appear in the upper
portion of the area of the advertisement statements required for packages in must appear in the same language as
within the trim area as follows: paragraph (a)(1) of this section must be that principally used in the
(i) Occupy at least 20 percent of the randomly displayed in each 12-month advertisement.
area of the advertisement; period, in as equal a number of times as
(ii) Appear in at least 12-point font is possible on each brand of cigar sold § 1143.9 Irremovable or permanent
required warning statements.
size that ensures that the required in product packaging and be randomly
warning statement occupies the greatest distributed in all areas of the United The warning statements required by
possible proportion of the warning area States in which the product is marketed this section must be indelibly printed
set aside for the text required; in accordance with a plan submitted by on or permanently affixed to the
(iii) Appear in conspicuous and the cigar manufacturer, importer, package or advertisement. These
legible Helvetica bold or Arial bold type distributor, or retailer to, and approved warnings, for example, must not be
(or other similar sans serif fonts) and in by, the Food and Drug Administration. printed or placed on a product label
black text on a white background or (2) The warning statements required affixed to a clear outer wrapper that is
white text on a black background in a for advertisements in paragraph (a)(1) of likely to be removed to access the
manner that contrasts by typography, this section must be rotated quarterly in product within the package.
layout, or color, with all other material alternating sequence in each
on the advertisement; advertisement for each brand of cigar in § 1143.11 Does not apply to foreign
accordance with a plan submitted by the distribution.
(iv) Be capitalized and punctuated as
indicated in paragraph (a)(1) of this cigar manufacturer, importer, The provisions of this part do not
section; distributor, or retailer to, and approved apply to a manufacturer or distributor of
(v) Be centered in the warning area in by, the Food and Drug Administration. tobacco products that does not
which the text is required to appear and (3) Each person required to randomly manufacture, package, or import tobacco
positioned such that the text of the display and distribute or rotate products for sale or distribution within
required warning statement and the warnings in accordance with an FDA- the United States.
other textual information in the approved plan under this part shall
submit a proposed warning plan to FDA § 1143.13 Effective date.
advertisement have the same
orientation; and no later than either 12 months after May (a) Except as stated in paragraph (b)
(vi) Be surrounded by a rectangular 10, 2016, or 12 months before of this section, this part will take effect
border that is the same color as the text advertising or commercially marketing a 24 months after May 10, 2016. The
of the required warning statement and product that is subject to such effective date will be with respect to the
that is not less than 3 mm or more than requirement, whichever is later. date of manufacture, provided that, in
4 mm. § 1143.7 Language requirements for any case, beginning 30 days after the
(3) This paragraph (b) applies to a required warning statements. effective date, a manufacturer may not
retailer only if that retailer is The text in each warning statement introduce into the domestic commerce
responsible for or directs the warning required in § 1143.3 or § 1143.5 must be of the United States any product,
statements required under the in the English language, except as irrespective of the date of manufacture,
paragraph. However, this paragraph follows: that is not in conformance with this
does not relieve a retailer of liability if (a) In the case of an advertisement part.
the retailer displays, in a location open that appears in a non-English medium, (b) The requirement to submit a
to the public, an advertisement that the text in the required warning warning plan to FDA under
does not contain a health warning or statement must appear in the § 1143.5(c)(3) will take effect 12 months
contains a health warning that has been predominant language of the medium after May 10, 2016.
altered by the retailer in a way that is whether or not the advertisement is in
Dated: May 3, 2016.
material to the requirements of this English, and;
section. (b) In the case of an advertisement Leslie Kux,
(c) Marketing requirements. (1) Except that appears in an English language Associate Commissioner for Policy.
for cigars sold individually and not in medium but that is not in English, the [FR Doc. 2016–10685 Filed 5–5–16; 8:45 am]
a product package, the warning text in the required warning statement BILLING CODE 4164–01–P

2016 FDA Rule On E-Cigarettes

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2016 FDA Rule On E-Cigarettes

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Department of Health and Human Services

G. Modified Risk Claims Required Warning Statements

TABLE 1—SUMMARY OF QUANTIFIED COSTS OVER 20 YEARS

and do not address specific points piecemeal deeming of specific

unknown risks that will be developed in employment of the premarket

TABLE 2—COMPLIANCE WITH VARIOUS AUTOMATIC PROVISIONS

902(1)–(5), (8) .......................................................................................... Effective date of part 1100.

TABLE 3—COMPLIANCE PERIODS FOR OTHER PROVISIONS

903(a)(2) .................................................... 24 months after the publication of this final regulation.

Effective date of part 1100 PLUS 13 months (stop distribution).

TABLE 4—COMPLIANCE POLICY FOR PREMARKET REQUIREMENTS—ENDS RETAIL ESTABLISHMENTS

deemed products. Several comments populations. information needed to calculate and

which is an indication of the sometimes expensive products. prohibition.

area set aside for the required text.’’

TABLE 5—SUMMARY OF QUANTIFIED COSTS OVER 20 YEARS ($ MILLION)

17 Throughout the final RIA, any reference to

‘‘flavored tobacco products’’ means flavored

1—Exempt Premium Cigars from Regulation ................................................. 959 794 64 75

estimate for the current year. Regulatory

TABLE 7—ESTIMATED ANNUAL REPORTING BURDEN 1

Tobacco Product Establishment Recurring Registration (electronic and paper submission):

TABLE 7—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued

Tobacco Product Listing Recurring (electronic and paper submission):

Obtaining a Dun and Bradstreet (DUNS) Number:

Tobacco Product Ingredient Listing (electronic and paper submission):

Certain Health Information.

Cigar Manufacturers (Including Large and Small) ............... 2 4 8 50 400

Cigar Manufacturers (Including Large, Small, and Import-

Total Hours (§ 1107.1(b)) .............................................. ........................ ........................ ........................ ........................ 7,656

Cigar Manufacturers (Including Large, Small, and Import-

Total Hours (§ 1107.1(c)) .............................................. ........................ ........................ ........................ ........................ 282

Cigar Manufacturers (Including Large, Small, and Import-

Total Hours Exemptions From Substantial

TABLE 10—ESTIMATED ANNUAL REPORTING BURDEN 1

Cigar Manufacturers (Including Large, Small, and Import-

Full SE Bundled 905(j)(1)(A)(i) and 910(a) and § 25.40 Environmental Assessments:

Cigar Manufacturers (Including Large, Small, and Import-

Total Hours ................................................................... ........................ ........................ ........................ ........................ 22,500

Same Characteristics SE Report and § 25.40 Environmental Assessments:

Cigar Manufacturers (Including Large, Small, and Import-

TABLE 10—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued

Total Same Characteristics .......................................... ........................ ........................ ........................ ........................ 19,646

Product Quantity Change Initial and § 25.40 Environmental Assessments:

Cigar Manufacturers (Including Large, Small, and Import-

Product Quantity Change Bundled and § 25.40 Environmental Assessments:

Cigar Manufacturers (Including Large, Small, and Import-

Total Hours (‘‘Reports Intended to Demonstrate

TABLE 11—ESTIMATED ANNUAL REPORTING BURDEN 1

TABLE 12—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2

Cigar Manufacturers (Large and Small) 57 3 171 22 3,762

TABLE 12—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2—Continued

Exports: Notification and Record-

TABLE 13—ESTIMATED ANNUAL REPORTING BURDEN 1 2

Cigar Manufacturers (including large and small cigars and

Total Hours Establishing that a Tobacco Product was

TABLE 14—ESTIMATED ANNUAL REPORTING BURDEN 1

Other Tobacco, E-Cigarettes, and Nicotine Product Manu-

Other Tobacco, E-Cigarettes, and Nicotine Product Manu-

TABLE 15—ESTIMATED ANNUAL REPORTING BURDEN 1

Certification Statement ......................................................... 1 1 1 20 20

Total Exemptions From the Required Warning State-

TABLE 16—ESTIMATED ANNUAL REPORTING BURDEN 1