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QUALITY ASSURANCE

A Critique of the Standardized Information on Dietary


Ingredients Protocol, Part I
Rick Liva, ND, RPh

Disclosure: Dr Liva is the president, CEO, and director of Quality


Control and Quality Assurance at Vital Nutrients, a company certi- SIDI Documents
fied by the Natural Products Association for current Good • Various documents on the Standardized Information on
Manufacturing Practices. Dietary Ingredients (SIDI) program can be found at
www.ahpa.org/SIDI/documents.html.

Editor’s Note: This is the first of a 2-part article. The second part will • The Standardized Information on Dietary Ingredients
run in the next issue, April-May 2010 (IMCJ. 2010;9.2). (SIDI) Protocol can be found at www.ahpa.org/SIDI/
PDFs/SIDIProtocolV2.1Feb08.pdf.

he Standardized Information on Dietary Ingredients (SIDI) Though SIDI’s goals are both much needed and well inten-

T Protocol was developed by the Standardized Ingredient


Information Protocol (SIIP) Working Group, a joint trade
association effort with participants representing both dietary
tioned—my hat is off to the SIIP Working Group who has
worked so diligently and hard to make this come about; it was
surely no easy task—I ask that before you read further you
supplement (DS) ingredient suppliers and finished product man- remember the words of one of my colleagues: “Paper never
ufacturers. Members of the working group include the Council for refuses ink.” In other words, people can say whatever they like
Responsible Nutrition (CRN), the American Herbal Products on a piece of paper because, in the end, the information will
Association (AHPA), the Natural Products Association (NPA), and most likely be accepted at face value—rarely does the recipient
the Consumer Healthcare Products Association (CHPA). spend time validating the information given, and, hence, nobody
The objective of the working group is to develop standard- is the wiser. In the vernacular: It’s often assumed that everything
ized guidelines and protocols that suppliers of vitamins, miner- is cool and as it should be because the paper says it’s so.
als, botanicals, and other dietary ingredients can voluntarily use
to help convey relevant and required information to finished A Look at FDA Regulations
product manufacturers that make capsules, tablets, liquids, etc, To best understand SIDI, let me give some background on
from these raw ingredients. The guidelines are intended to be the June 2007 US Food and Drug Administration (FDA) Dietary
both comprehensive and flexible so as to apply across all prod- Supplement current Good Manufacturing Practices (cGMPs)
uct categories. The reason for the guidelines is to address the regulations. The regulations are laws subject to legal penalty if
prevailing need for communicating information in a standard- not followed by DS manufacturers.
ized manner, effectively reducing paperwork and resources cur- FDA’s definition of quality per the cGMP regulations means
rently dedicated to this process. that a dietary supplement consistently meets established specifi-
The SIDI protocol achieves 3 main functions: cations for identity, purity, strength, composition, and limits on
contaminants of raw materials as well as that it has been manu-
1) The program integrates information on raw sourcing for factured, packaged, labeled, and held under conditions to pre-
dietary ingredients (from suppliers or their brokers and/or dis- vent adulteration. Since SIDI deals only with the first half of
tributors; hereinafter just referred to as suppliers) into volun- these requirements—specifications for identity, purity, strength,
tary, standardized forms (templates), thereby eliminating the composition, and limits on contaminants of raw materials—
need for each manufacturer to have its own questionnaire to that’s all I’ll be addressing in this article (so nothing on finished
certify a supplier; products). SIDI also addresses labeling and regulatory informa-
2) through these templates, the program defines the minimum tion as it relates to raw materials, but I won’t delve into that
type and scope of information that should be covered; and either until Part II.
3) these templates provide a forum for suppliers to develop Although the FDA’s definition of quality for raw materials
their own dietary ingredient data sheets (DIDS) to be sent to sounds neat and tidy, there are 3 glaring omissions: 1) To date,
manufactures in lieu of answering disparate questionnaires from the FDA has established only a requirement for mandatory iden-
each manufacturer. tity testing of each incoming batch of material—but it has given
no specifics (and very, very little guidance) on how to meet the
The protocol provides 3 templates: Botanical Materials, Non- quality requirements for purity, strength, composition, and
Botanical Materials, and a Site Quality Overview Data Sheet. limits on contaminants of raw materials. 2) The final FDA DS

34 Integrative Medicine • Vol. 9, No. 1 • Feb/Mar 2010 Liva—Quality Assurance


cGMPs do not (preposterously) apply to ingredient suppliers. (ii) Rely on a certificate of analysis from the supplier of
Thus, the responsibility for ensuring the quality of dietary ingre- the component that you receive, provided that:
dients falls on the finished product manufacturer rather than the (A) You first qualify the supplier by establishing the
ingredient supplier. 3) Since the FDA has given no specifics on reliability of the supplier’s certificate of analysis
how to meet the quality requirements for purity, strength, com- through confirmation of the results of the supplier’s
position, and limits on contaminants of raw materials, the exact tests or examinations;
specifications are set by each individual manufacturer itself and (B) The certificate of analysis includes a description of
are open to no end of interpretation and fiddling. the test or examination method(s) used, limits of the
FDA quite grievously missed the boat on all 3 of these test or examinations, and actual results of the tests or
points—and more besides; to see detailed information, please examinations;
see my article “New FDA cGMPs for Supplements: Smoke or (C) You maintain documentation of how you qualified
Substance?” (IMCJ. 2007;6.5:28-32) as well as an article by the supplier;
Joesph Pizzorno, ND, in this same issue, “FDA’s Natural Product (D) You periodically re-confirm the supplier’s certifi-
cGMPs—A Missed Opportunity” (IMCJ. 2007;6.5:8-10). cate of analysis; and
To belabor the last point: Although FDA regulations revolve (E) Your quality control personnel review and approve
around setting specifications for DS raw materials and finished the documentation setting forth the basis for qualifi-
products, the exact specifications are determined by individual cation (and re-qualification) of any supplier.
manufacturers who are provided no standardized requirements.
That is to say, the rule requires that manufacturers, not the FDA, As written, these regulations are nonspecific and leave
define quality specifications for their products—and those much room for cheating or doing the very least and falling short.
specifications can (with very few exceptions) be as loose or as Consider the following:
tight as determined by each manufacturer. The law simply
requires the manufacturer to define the specifications for iden- (2) (i) above states that if you are going to follow regulations
tity, purity, strength, composition, and limits on contaminants for each lot received, you need to “conduct appropriate tests or
and to make certain that the processes in place guarantee that examinations.” The problem is, as explained before, these
the finished products meet those specifications. “appropriate” tests and examinations are never specified so are
It seems pretty obvious that the regulations are extremely thus determined by each manufacturer.
weak since FDA gives no guidance as to the minimum specifica- If you are not going to test each lot received, so are therefore
tions that must be met. Ergo, 1 DS manufacturer can set mini- going to do skip lot testing, there are also serious deficiencies in
mal specs that it decides will comply and another can set a the regulations.
comprehensive spec that actually does cover all the necessary (2) (ii) (A) above states that you must confirm the results of
bases. Unfortunately, however, there is a financial incentive to the supplier’s tests or examinations listed on the certificate of
set minimal specifications because it will cost less money over analysis (COA). The begged questions are 1) what are the mini-
time to meet them. And no one will really be any the wiser, mum tests or examinations that need to be performed for each
because the manufacturer has followed the letter of the law. type of material and 2) since no specific tests are required, how
In specific, the FDA regulations state the following. Note are you to determine if the tests/examinations that the manufac-
that identity is the only required test1: turer chose to do are any good? The answers: For #1, the DS
manufacturer gets to choose because no FDA guidance is pro-
Subpart E § 111.75 What must you do to determine vided; for #2, unless you have a qualified lab person to ask, you
whether specifications are met? aren’t going to know.
Before you use a component [also known as a raw There is also a third question: How many times should said
material], you must: tests/examinations be performed (to gain confidence in the sup-
plier) before you can start skip lot testing? No guidance is pro-
(1) Conduct at least one appropriate test or examina- vided. How often do you skip? No guidance is provided. This is
tion to verify the identity [author emphasis] of any (obviously) extremely unclear and left wide open.
component that is a dietary ingredient; and (2) (ii) (D) states that “You periodically re-confirm the sup-
(2) Confirm the identity of other components and plier’s certificate of analysis.” I ask again, “How often?” No guid-
determine whether other applicable component speci- ance is provided. So will it be every 2, 3, 4, 5, or 10 years? Who
fications established [are met]. . . . knows how the FDA left that important detail out! But because it
did, there is a lot of wiggle room for doing the least amount of
To do so, you must either: due diligence possible.
Another problem is that (2) (ii) (B) states that the COA
(i) Conduct appropriate tests or examinations [this should include “a description of the test or examination
means for each lot received]; or [if you are not going to method(s) used, limits of the test or examinations, and actual
test every lot, you can do the following] results of the tests or examinations.” In reality, most COAs don’t

Liva—Quality Assurance Integrative Medicine • Vol. 9, No. 1 • Feb/Mar 2010 35


include this information. Although this should technically mean 4. Rather surprisingly, the appearance and format of the
that a manufacturer shouldn’t do skip lot testing because 1 of the template provided to the manufacturer is left to the dis-
COA requirements is not met, the question remains whether the cretion of the ingredient supplier—SIDI only “strongly
manufacturer actually adheres to this requirement—since, in recommends” that the format and organization of the
reality, so few COAs include it and a large number of manufac- provided SIDI template be followed. I have a major
turers do skip lot testing. problem with this, as the template can be changed by
the supplier, which could lead to confusion and incon-
Life Without SIDI sistency as well as undermine the “template” nature of
Typically, quality-minded companies send supplier certifi- the program. What is the point of having a “template” if
cation questionnaires asking a myriad of questions designed to it is left so flexible?
elicit information regarding a supplier’s quality practices. 5. And the most major drawback, as I stated earlier, is that
Sadly, I’ve always felt that most of these questionnaires are yet the templates are merely ink on paper—how does any-
another useless paper tiger for 2 reasons: 1) as with SIDI, sup- one know that what is written is true? No one knows
pliers can say whatever they want and the sender is still clueless without the DS manufacturer verifying much of the
as to the veracity of the info (again, “paper never refuses ink”), information provided. Hence, the templated SIDI info
and 2) if your supplier is itself a broker or distributor that is that suppliers provide is just the tip of a very large ice-
getting ingredients from many places (as is often the case with berg. Why? Because even after a manufacturer is handed
products such as vitamins, amino acids, minerals, etc), the bro- a filled-out SIDI template, the information still has to be
ker or distributor you use may change the supplier it used for vetted through the same scientifically valid comprehen-
previously “certified” material(s) and never tell you. So, even if sive testing I write about each issue.
your broker/distributor provides accurate and complete infor-
mation today, next week you may be getting raw material that SIDI is a good first step, but the trade groups that put it
originated from a different supplier, thus negating the original together would be wise to tackle 4 much more monstrous prob-
information sent. lems befouling the industry: 1) a paucity of scientifically valid
It is due to all these shortfalls that I created “The IMCJ methods and standards to test these materials, 2) a paucity of
Supplement Quality Audit Form.” (This can be found at www. trustworthy labs to use those methods and standards, 3) a gov-
imjournal.com. In the menu bar, click on “Resources and ernment that does not set quality standards and enforce compli-
Content.” The second listing on the drop-down menu is “Quality ance of those standards on the labs that test these products, and
Assurance.” On the corresponding web page, you will find the 4) as shown above, the FDA GMPs’ provision of very wobbly
form.) The benefit of this form above others I’m aware of is that guidance, if any, for what testing is “required” under the regula-
it directs suppliers to answer a series of questions but also asks tions to vet a dietary ingredient or finished product or to certify
for documentation that helps provide verification that they are, a dietary ingredient supplier’s COA for a specific material.
in fact, doing what they claim to be doing. The questionnaire Beyond these limitations that are critical enough to derail
asks for proof as well as yes-or-no answers. It is easy to answer yes any of the good the SIDI program hopes to do, there are numer-
to a question on a form; it is more difficult to provide proof. ous other shortcomings:

SIDI Shortfalls 1. Suppliers can just say, “No, I’m not going to be part of
The SIDI program concept is to have every supplier use the the SIDI program.” And, for now, that is that. Although,
same template so everyone is providing the same level of com- to their immense credit, the SIIP Working Group has
prehensive information to the manufacturer. While that may be started the ball in motion to have such a program be a
very useful (because it might save both sides time and energy, mandatory part of running a DS company.
which equals dollars) it may not be practical for numerous rea- 2. I mentioned in the beginning of this article that the rea-
sons. The 5 main reasons are as follows: son for the SIDI guidelines is to “address the prevailing
need” to reduce paperwork and resources currently ded-
1. The program is voluntary and not enforceable. icated to the process of determining supplement quality.
2. Many of the questions on the template are broad and In the end, however, SIDI could cost the ingredient sup-
open ended, leading to potentially inadequate answers. pliers more time and money to develop, write, and pro-
(This occurs even on the example template filled in by vide the comprehensive amount of information the
SIDI—next issue I will show you this as I go over an templates require. The reason is simple enough: Say you
example of a completed SIDI Botanical Template.) are a supplier with hundreds of raw materials. You
3. It does not specifically include all the categories of would have to pay to have someone to write, compile,
information that it should. (Again, next issue I will give and store all of the required SIDI documents—no small
comments on what the templates are missing.) task for that many raw materials. In addition, you
would have to keep someone on the payroll to revise
In regard to both 2 and 3, we hope that the SIIP Working documents as needed and to prepare new documents as
Group will consider upgrading the templates. new materials come on line.

36 Integrative Medicine • Vol. 9, No. 1 • Feb/Mar 2010 Liva—Quality Assurance


3. Along these same lines of workload and resources, any For both, I don’t see how, just because I’m putting more
changes to a product would require updating of all the information on a piece of paper that is not required to be veri-
SIDI forms, whereas now the supplier only has to change fied, this is going to reduce risk of error or increase the safety and
its COA—an inherently simpler process. quality of products. It just offers a starting point, while the stated
4. And an insurmountable limitation: Although I wish this goal of certification is accomplished only by scientifically valid
wasn’t the case, in my experience, most ingredient sup- comprehensive testing to vet what is written. If asked, anyone
pliers keep their COA and Specification Sheets vague would agree that the safety and quality of dietary supplement
and simple so they don’t have to reveal potentially dam- products is paramount. However, the SIIP Working Group
aging information such as inadequate testing or the doesn’t give specifics as to how the program could increase
presence of toxins or chemicals. safety and quality (they just allude to it). It would be useful for
Case in point: In the past 2 years I rejected 3 batches them to provide detailed, specific information on the points of
of diindolymethane (DIM) because of high levels of ben- safety and quality.
zene (500-600 parts per million, ppm). The presence of Hence, I would like to see the SIIP Working Group give sug-
benzene was not even listed on the COA. I found it gestions and guidelines for minimum (but adequate) scientifically
because we test all materials for 51 solvents—for the valid testing requirements for botanical and nonbotanical materi-
exact purpose of catching contaminants not revealed on als that a DS manufacturer can use to vet a supplier’s information.
COAs. The truth is, if the supplier were to reveal this sol- Since the FDA has chosen to be vague, why can’t the industry step
vent residue on the COA at that level, nobody would buy in and provide quality testing guidance parameters for all DS
it due to its toxic nature. If it chose to honestly follow the manufactures to follow? It would certainly help to diminish the
SIDI protocol of supplied information (and it is doubtful confusion as to what might meet FDA requirements.
that it would do so then when it did not do so now), it As mentioned, next issue I will discuss the sample Botanical
would have to clean up the product to eliminate the ben- Template filled in by the SIIP Working Group and offer sugges-
zene, which would cost it money and time—2 costs it tions as to what would make the templates stronger.
doesn’t have now. I can only surmise that this economic The intent of the SIDI protocol is clearly positive and of sig-
disadvantage would keep them out of the SIDI program. nificant value for dietary supplement manufacturers. I suggest
To continue the story, I found a new supplier of that it needs a more detailed structure that is not variable and has
DIM. Two batches in the past 2 years passed solvent res- mandatory compliance if a supplier is willing to adopt it.
idue testing with no problems. Then, just recently, the
third batch showed 280 ppm of chlorobenzene, a less
toxic solvent than benzene but one that, in my opinion, Rick Liva, ND, RPh, graduated from Temple University School of Pharmacy in
doesn’t belong in a “health” supplement. It also was not 1975 and National College of Naturopathic Medicine in 1982. He is the manag-
ing physician at the Connecticut Center for Health, located in Middletown and
declared on the COA—yet, as I found out, it is routinely West Hartford. Dr Liva is a founding member of the American Association of
used in the manufacturing process to whiten the materi- Naturopathic Physicians and past president of the Connecticut Society of
al, and then the supplier doesn’t spend the required Naturopathic Physicians. As mentioned in the disclosure, he is also the presi-
time to blow it off in the drying phase. So once again, if a dent, CEO, and director of Quality Control and Quality Assurance at Vital
Nutrients, a company certified by the Natural Products Association for current
supplier chose to honestly follow the SIDI protocol of
Good Manufacturing Practices.
supplied information, it would have to clean up the
product to eliminate the benzene, which would cost it Reference
money and time—2 costs it doesn’t have now. 1. Department of Health and Human Services. US Food and Drug Administration.
§111.75 What must you do to determine whether specifications are met? Current
It should also be noted that, without the testing I Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding
did, neither the SIDI forms nor the FDA cGMPs would Operations for Dietary Supplements: Final Rule. College Park, MD: Food and Drug
Administration; 2007:773.
have caught either issue.
5. Some of the information that the templates ask the sup-
pliers to provide is possibly of a proprietary nature
(intellectual property), such as a method of analysis or
an extraction or production process.

The SIDI Program’s Claimed Promises


Even with the limitations above, the SIDI program prom-
ises that

• increased standardization of any process has the poten-


tial to reduce risk of error and
• a more organized system of vendor qualification could
increase the safety and quality of products.

Liva—Quality Assurance Integrative Medicine • Vol. 9, No. 1 • Feb/Mar 2010 37