This Report explores the development of
scientific proof of the harm that tobacco poses to human
health and the legal tools used to regulate its use.
Efforts on the Part of the Industry to Understand Nicotine
- Advertising had been targeted particularly to those
that were most vulnerable to adopting cigarette products.
There is an overlap obviously between the intensity
of physical activity among the young, so that the youngest are
most physically active.
- And those that participate in sports became figures
that promoted tobacco use in a variety of different media.
There was a concentration, not just to target women and
ethnic groups, but also exceptional athletes in a variety of
different sports.
-Other kind of Tobacco products is a chewing
tobacco. It is common at all among baseball players.
The National Cancer Institute has a site that reviews
the presence of twenty-eight different carcinogens in
smokeless tobacco, and has three (3) to four (4) times the
nicotine level. . So that those that are chewing tobacco
absorb far more nicotine and it can be measured at higher
concentrations in the blood than if you have a cigarette. It
also recognized to increase risk of oral; cancer that can cause
bone degeneration and different illnesses of the
nasopharyngeal cavity.
-The idea of freedom of choice relative to children
growing up in families that smoked. The estimate today is
about twenty-five (25) percent of kids between the ages of
three and eleven grew up with one smoker in the household.
- There are many other hazardous chemicals in
tobacco smoke, other than nicotine.
- Dozens of compounds are really very well
recognized and they are the targets of a variety of different
types of environmental laws.
- Pesticides used to produce tobacco, according to
an expert in Switzerland.
- 101 different pesticides used on tobacco
-research projects has been to explore patents as a
way of understanding what a corporation knew about a
product and when they knew it and how their advertising
matched up with their background knowledge of benefit as
opposed to risk
-An article that was published by a researcher in
Tobacco Control Journal, and it references a memo that was
quoted in that journal. “we are searching explicitly for a
socially acceptable addictive product involving a pattern of
repeated consumption, a product which is likely to involve
repeated handling the essential constituent is most likely to
be nicotine or a direct substitute for it”
-so there are debates were going on inside the
Congress over w/n nicotine is an addictive drug.
-One Congressman asked them, Henry Waxman from
California, “Gentlemen, is tobacco or is nicotine addictive?”
And each one of them went down the row, “No, it is not
addictive.
Tobacco Industry Challenges FDA; Various Settlements
- Major medical organizations around the world had
concluded that nicotine is addictive, including the U.S.
Surgeon General, the World Health Organization, et cetera.
U.S Surgeon General
World Health Organization
American Medical Association
American Psychiatric Association
American Psycological association
The Royal Society of Medicine
Medical Research Council, U.K
- they developed proposal, and it included a ban on
cartoons graphics; Text only Allowed; Ban Brand Names on
Hats, T-shirts and other products; Event sponsorship: Require
Corporate Name Not Product Name; Eliminate Vending
Machines, Free Samples, Mail Order ; 22% of 13 yrs old and
2% of 17 yrs old buy from VM’s; Eliminate Self Service in
Stores; Suspend Licenses to those who sell to minors.
- The FDA rule proposed in August of 1996 by
President Clinton at Kessler’s urging was announced by the
Food and Drug Administration
HISTORY OF FDA RULES
- The tobacco industry, within a matter of a couple of
months, filed a lawsuit against the FDA rule arguing that the
Food and Drug Administration had no authority over tobacco
products under the Food, Drug, and Cosmetic Act, basically
that tobacco products were not a drug, that the cigarettes or
the cigars were not a drug delivery device. And they also
argued that FDA’s rules on marketing restrictions violated the
First Amendment. So we had the right to make claims about
our product and to sell it. The major plaintiffs in the case
included these corporations.
-John McCain introduced the Universal Tobacco
Settlement Act; the Senate passed a revised version of the
McCain bill that included many elements of the FDA rule.
- But it was defeated in the Senate just about a year
later. The U.S. Court of Appeals ruled in a two-to-one vote
that FDA had no authority to regulate tobacco products in
1999.
- recognition of the medical costs associated with
treating people that had tobacco-related illnesses, attorneys
general from more than forty states got together and
launched a lawsuit.
- And this eventually was settled. It was called the
Master Settlement Agreement with the Tobacco Industry.
- In 1998, the attorneys general from forty-six states
signed this agreement with four of the biggest companies,
tobacco companies, in the nation. And it prohibited tobacco
advertising that targeted kids younger than eighteen years of
age. So, once again, this is kind of an interesting story that
kids play an important role in the history of the product
regulation.
- key elements of this settlement
- 1st that tobacco companies could not use cartoon
characters, that tobacco companies could not target youth in
advertising or promotion.
Tobacco companies could not sponsor concerts or
other events with significant youth audiences. And tobacco
brand names cannot be advertised at stadiums and arenas.
- And you find the attorneys general using litigation
as a way of forcing settlement so that you get the companies
themselves to agree that they’re not going to do these things.
That’s a very different approach than having FDA tell them
that they can’t do those things. And then you have the
McCain initiative in Congress.
- like other types of environmental problems, there
are certain groups in society that are at special risk. And in
this case the Americans with Disabilities Act was used to
eliminate or limit environmental tobacco smoke in the
workplace. And it requires that an employer make a
reasonable accommodation to the known disabilities of an
employee who requests the accommodation. So that workers
used the Americans with Disabilities Act effectively to clear
up the air within workplaces.
- the Food and Drug Administration case versus
Brown & Williamson and the Supreme Court ruling on March
of 2000
They concluded that existing law does not provide
FDA with authority over tobacco or tobacco marketing. They
claimed that FDA consistently stated before 1995 that it
lacked jurisdiction over tobacco. So the shift in the
administrator of the Food and Drug Administration, they
were arguing, was the only reason that they were taking this
issue on. And the Congress had enacted several tobacco-
specific statutes that fully demonstrated that they had not
intended that these regulations proposed by the Food and
Drug Administration be adopted. So Congress considered and
rejected many bills that would have given the agency that
authority. So the argument that the Supreme Court bought
was that this was a matter that should have been dealt with
in Congress specifically, but Congress chose not to deal with
it.
If it’s a Drug, Where’s the Benefit?
That the definition of a drug turned out to be dependent in
turn about whether or not there was an identifiable benefit:
“Various provisions in the Act require the agency to
determine that at least for some consumers, the product’s
therapeutic benefits outweigh the risks of illness or serious
injury…This the FDA cannot do, because tobacco products are
unsafe for obtaining any therapeutic benefit.
The inescapable conclusion is that there is no room
for tobacco products within the FDCA’s, Food, Drug, and
Cosmetic Act’s, regulatory scheme. If they cannot be used
safely for any therapeutic purpose and yet they cannot be
banned, they simply do not fit” the legal scheme that
Congress had intended.
-Sandra Day O’Connor wrote this opinion: “The
agency has amply demonstrated that tobacco use,
particularly among children and adolescents, poses perhaps
the single most significant threat to public health in the
United States.” Yet, “we believe that Congress has clearly
precluded FDA from asserting jurisdiction to regulate tobacco
products.”
-Supreme Court was off their rocker, that they really
were concluding something that was not morally defensible.
 - “Congress has foreclosed a ban on such products,
choosing instead to create a distinct regulatory scheme
focusing on the labelling and advertising of cigarettes and
smokeless tobacco.
- Compared to pesticides, where they created a
scheme that now stands that the agency, in that case the
Environmental Protection Agency, has to make a formal
finding of reasonable certainty of no harm. Not in this case.
Not in this case at all. So that the focus on labeling and
advertising, rather than on risk assessment or risk
minimization, is a very different approach to managing a
product or a technology in the marketplace. So its express
policy is to protect commerce and the national economy
while informing consumers about any adverse health effects.
-How were they so successful in escaping regulation?
It’s almost the ideal situation. So that they have the sense of
being regulated because of the advertising controls, but they
have virtual freedom to manipulate the chemical composition
of their products.
-Justice Breyer’s dissent on FDA’s authority is
interesting.
”According to the FDA, only 2.5 percent of smokers
successfully stop smoking each year, even though seventy
percent say they want to quit and thirty-four percent actually
make an attempt to do so…The fact that only a handful of
those who try to quit smoking actually succeed illustrates a
certain reality. The reality that the nicotine in cigarettes
creates a powerful physiological addiction flowing from
chemically-induced changes in the brain…The FDA found that
the makers of cigarettes intend these physical effects, hence
nicotine is a drug, the cigarette that delivers the nicotine to
the body is a device, and the FDCA’s language, read in light of
its basic purpose, permits the Food and Drug Administration
to assert the disease-preventing jurisdiction that the agency
now claims.”
Chapter 4. Family Smoking Prevention and Tobacco Control
Act
- So this bill adopted by Congress amends the Food,
Drug, and Cosmetic Act to grant the Food and Drug
Administration authority to regulate the advertising,
marketing, and manufacturing of tobacco products.
- a) It restricts tobacco marketing and sales to youth.
b) It bans all outdoor advertising within 1,000 feet of schools.
c) It bans free giveaways of any non-tobacco items with the
purchase of a tobacco product. d) It bans the sponsorship of
sporting events and entertainment events. e) It limits to black
and white text only advertising in publications with significant
teen readership and restricts vending machines and self-
service displays to adult-only facilities. And it continues to
require retailers to verify age for all over-the-counter sales.
- The tobacco settlement was not law that was
formed by statute. It was not formed by regulation; it was
formed by agreement between attorneys general of the
states and the tobacco companies.
- The language being moved from the Food and Drug
Administration’s proposed regulations into statutory
language, and this was blessed by Congress. It provides FDA
with authority to develop regulations that restrict advertising
and promotion to the full extent permitted by amendment to
the Constitution and it requires a detailed disclosure of
tobacco product ingredients for the first time. So the tobacco
companies have to disclose not just chemicals used for the
growing of tobacco, but the chemicals in the tobacco plants
themselves, whether or not they’re genetically modified, and
what kinds of additives they placed, not just in the tobacco
but in the filter as well as the paper. It also requires the FDA
to require changes to tobacco that would protect public
health. So public health now is a decision-making standard
that has to be viewed and treated with every decision that
FDA makes.
- one critical aspect of this new statute is that FDA is
now allowed, granted the authority to reduce nicotine
content or to ban ingredients that it believes are hazardous,
but it’s not allowed to require the reduction of nicotine to
zero or to ban any particular class of products, say cigars or
chewing tobacco as an example. It also controlled, gives, FDA
the authority to control reduced-harm products so that the
descriptors such as “light” or “mild” or “low” on labels or in
advertising will now become subject to the review of the
agency. You’ll remember that the light products that I showed
you last Tuesday had higher nicotine content in them than
the normal products.
And it requires larger and more specific health
warnings to cover the top fifty percent of the front and rear
panels of the package. And it directs the FDA to issue a rule
requiring graphic warnings on labels within a year from now.
So recall the Canadian government’s tobacco labeling
requirements as an example. Curiously, they also transfer the
costs of all regulation back to the companies so that all
tobacco-related Food and Drug Administration costs now
have to be allocated among the manufacturers of cigarette
tobacco and smokeless tobacco products sold in the U.S.
based upon their different shares of the marketplace.
Chapter 5. Control Programs; Mass Media; Science and
Industry
-states became very active in their own tobacco
control programs. And these programs turned out to be really
remarkable social experiments. They turned out to be quite
effective. In California, adult smoking dropped from twenty-
six percent to eighteen percent in about an eight-year period
following a variety of educational campaigns, public service
announcements, school programs. So that Massachusetts
similarly found a thirty-one percent decline between 1992
and 1999. In Oregon, tobacco use fell eleven percent. In
Florida in one year, teen smoking had gone down the fastest
that it had since 1980.
- The key elements have been mass media
campaigns, smoking bans and restrictions, particularly in
public places, in buildings as well as restaurants. Price
increases, they found that tobacco adoption rates were
extremely sensitive to tax levels. So in the states that had the
most elevated taxes, you had the lowest adoption rates. In
states that had the highest intensity of bans on place-based
restrictions, restrictions in buildings, they had the highest
rates of quitting. So that price sensitivity turned out to be a
really important component of the strategy. And they also
found that different types of physician interventions —
nicotine patches — were much more effective when they
were combined with these other educational programs than
they had earlier believed.
- So basically another lesson here is that mass media
works. And remember the 1967 Fairness Doctrine campaign
that itself resulted in a significant decline in smoking. In
California, the media campaign reduced sales of cigarettes by
232 million packs in only a two-year period. And when media
spending dropped from sixteen million to six million, the
program became less effective. So that education is really
important and it works.
-one of the greatest examples we’ve got about how
science had moved out of the tobacco industry into the public
sector funded by the government. A very different view
evolved of what was risky and what was not. A different
quality of knowledge developed about the nature of the
health risks. And it eventually led the public to realize that
this was a technology, this was a product that demanded
greater public attention.
Chapter 6. p; Environmental and Consumer Group
Arguments
- Strategically regulate rather than ban. Argue that
well, can I use the product in this way but not that way? Can I
continue to sell the tobacco in cigarettes if not cigars? Could I
continue to use a pesticide outdoors if you ban it indoors? So
try to maintain market share anyway that you can, and if you
can’t, if they decide no it’s going to be banned, then let us
export it. Please let us export it to other nations. Substitutes,
don’t compare us among competitors. Make sure that you
focus exclusively on our product because we don’t want the
risk, the threat, the environmental damage from our product
to be thought of an in an additive way with competitors’
products.
Environmental and consumer groups’ arguments
-their response has been pretty consistent.
- shift the burden of proof back to the private sector
to demonstrate safety
-Second, they’ll argue that evidence is insufficient to
justify finding safety. So they will delay for the same reasons
that industry would delay, saying that the evidence is
insufficient to justify increased regulation. But if this burden
of proof is switched, it’s basically providing a mirror image to
the former regulatory regime.
- Susceptibility. Think about how susceptibility varies
in the population. Again, all the cases that we’ve looked at in
the course so far have involved those that are especially
vulnerable, those that are especially exposed. So look at
exposure patterns and how they vary by age class. Look at
variability by ethnicity. Look at differences in use patterns or
behavior among different ethnic groups, perhaps in different
seasons, perhaps in different parts of the country, so that
looking at variability and how that plays out in how goods and
bads are distributed is really important to all the cases.
- Think about mixtures. Don’t just regulate single
products or single compounds, but think about regulating the
entire mixture. Tobacco smoke is a good example. It’s the
mixture that’s being regulated, not the individual component,
with the exception of nicotine. Aggregated exposure. So think
about where you might get exposed to the same kind of
threat from a variety of different sources, from air, from
water from foods.
- remember the idea of a new technology that would
change vehicle emissions under the Clean Air Act? That
requires a four-year period that the industry has to retool, to
think about how they’re going to redesign their engines to
meet that new standard.
- Restricted use and label changes and ecological
restrictions are often critical arguments of environmental and
consumer use, consumer protection groups. And
environmental testing, make certain that the environmental
testing is independently conducted.

- Environmental groups will commonly oppose

preemption because they want 1,000 regulations to bloom.
They want California to have the opportunity to adopt more
rigorous regulations, because California’s population and
consumer market share is so extraordinarily high as a
percentage of the U.S., what happens in California is going to
happen in the United States. And what happens in the United
States is going to happen abroad. So if you restrict the ability
of a lower level of government to adopt these regulations,
then you are not going to have the innovation in legal reform
that you otherwise might.