Prof: All right
everybody, let’s start in. So the midterms are graded,
for those of you that are not doing the paper.
And you’ll receive them back on
Thursday in class. And people for the most part
did quite well. So it’s good news.
Today I want to talk about
tobacco and the legal paradigm that surrounds tobacco,
because it really provides I think an interesting comparison
to some of the other legal regimes that we’ve taken a look
at so far in the course, including those that surround
air quality, pesticides, atomic weapons
testing, hazardous sites, and plastics.
So how is tobacco managed?
What’s its history?
And I have come to think about
this history really as a conflict of perceptions of
rights and obligations, particularly the right to
participate in markets, the right to speak freely,
the right to advertise, as opposed to the right to be
free from exposure to chemicals that are recognized to be quite
hazardous. So all these cases that we’ve
looked at so far during the term really have raised questions
about risk and different approaches to managing risk.
What are the different legal
strategies that you might think about to take on a hazard such
as this? Well one is taxes.
We’ll take a look at tax policy
and how tax policy creates a dependency relationship between
an industry and governments, particularly at times like this
of budgetary stress. We’ll take a look also at
place-based restrictions. So preventing the sale of
certain hazardous commodities in certain kinds of environments so
that we can no longer purchase tobacco products in vending
machines in the United States. Instead they have to be
purchased over the counter by someone who would check
identification. Sales restrictions of different
sorts, advertising restrictions, fair warning requirements on
tobacco products. Also compensation,
how are we going to manage compensation for those that
claim that they’ve been harmed by the products?
How are we going to subsidize
the industry? You probably know that many
different commodities, agricultural commodities,
receive rather high subsidies. So what has been the relative
history of tobacco subsidies compared to other commodities?
How about regulating the
chemical content of tobacco, flavoring agents,
coloring agents, the shape of tobacco?
How about tobacco products
designed to sooth? Or how about the regulation of
nicotine itself, known to be addictive?
How about the ban on all
tobacco products? Has anybody thought about doing
that at any scale? Well, many governments have
chosen to ban use of tobacco products inside buildings,
so public buildings commonly now restrict the use of tobacco
products. Also, how about socializing the
industry, an idea that Kessler came up with at the end of his
book. So what’s the scale of this
issue in terms of economics? About fifty billion dollars
today in consumer spending and about fifty million people in
the United States smoke approximately 600 billion
cigarettes each year. The overwhelming majority of
those cigarettes, by the way, are lit and smoked
indoors so that this is very much an indoor air quality
issue. About four billion cigars are
smoked also, forty million pounds of tobacco are burned
indoors every year. How about tobacco-related
illnesses? There’s very little debate
about this, compared to the other types of
problems that we’ve looked at that are managed by
environmental law, including pesticides,
including air pollutants, drinking water contaminates
managed by the Safe Drinking Water Act or chemicals that are
migrating from hazardous waste sites.
The quality of the scientific
evidence about the effect of tobacco on human health is
really the gold standard. It’s similar in quality to our
understanding of the role that radiation plays in inducing
cancer. There are also about 470,000
different suppliers, wholesalers and retailers that
are highly dependent upon this industry.
So this is a recipe for
enormous conflict in Washington about how to use the different
strategies that I just went over.
So the way that the laws have
evolved in the U.S. was laid out I think fairly
well in Kessler’s book. The strategies that the
government has relied on have included hazard warnings
predominately, control over advertising claims
and the use of specific media outlets,
age restrictions so that within the United States right now the
use of tobacco products, the sale of tobacco products is
restricted to those that are eighteen years and older,
although there are some states and some counties that now
demand that you need to be nineteen years old.
in Nassau County, Suffolk County in New York,
demand that you be nineteen years old.
If you look around the world
too, there’s quite a bit of variability.
In some of the poorer nations
of the world, you need to be ten years old.
In France, you need to be
sixteen years old. In Japan, you need to be twenty
years old. So that the idea of age-based
restriction is really quite variable across different
jurisdictional boundaries. Restricting access,
making certain that you can’t just walk up to a machine and
put your now seven or eight dollars into it to get your pack
of cigarettes out. The removal of subsidies,
but not prohibition. So that Congress considered a
variety of strategies, but they always backed off of
prohibition. How about industry strategies
to maintain their share of the marketplace, what have they
done? Well, one of the first things
that they did was to focus the issue, focus government’s
attention on labeling. And as with pesticide labeling
and the labeling of pharmaceuticals and food
products, labeling is a problematic form of conveying a
sense of risk. This is especially different
than pesticides or some drugs in that the product itself is
addictive. It’s addictive predominately
because of the nicotine content. The industry also fought to
confuse the evidentiary base on health effects.
So just like nuclear weapons
and just like pesticides and pharmaceuticals,
the knowledge about the danger grew from the industry research
itself. So the American Tobacco
Institute, for example, might be thought of similarly
to the Atomic Energy Commission or to the pesticide companies
that conducted their own analyses of data so that they
became the source of data to demonstrate the absence of a
clear understanding about adverse health effects.
Also in advertising,
they really took very bold moves–
and I’ll go through a variety of different advertising
strategies today with you– to associate tobacco use with
the ideas of freedom, values of nature,
also sociability and sexuality. So the imagery is very
important. It’s extremely important,
and also quite persuasive to the very young.
They focused on the costs of
regulations, not the costs of healthcare.
And it’s quite interesting to
think about the sea change that occurred as a result of
litigation in Florida against tobacco companies that resulted
in a settlement. So that many attorneys general
in the United States banded together and were able to reach
a settlement for approximately two hundred and fifty billion
dollars to be paid out by the tobacco companies to different
states, year by year.
A study at Yale just a couple
of years ago demonstrated, by the way, that the money that
came into Connecticut did not go into educational funds,
educational programs to prevent tobacco use or to increase the
rate of quitting of tobacco use. Instead, it was diverted into a
variety of other state needs. So this balancing of the costs
of regulation, as opposed to the benefits of
the product, has been central in their logic.
Also, the idea of preemption.
Just as pesticides are
preempted so that they can’t be regulated differently,
the labeling can’t vary from state to state.
So that the tobacco companies
went to the federal government and were successful in
preempting state and local regulation regarding both
labeling and tort litigation. So preemption basically
prevents this patchwork quilt of regulations from being imposed
on the industry. If you look at the variability
of taxation by state, it’s also quite curious.
So that in the state of Rhode
Island, the state tax is about two
dollars and forty-six cents per pack,
whereas the state of Kentucky it was down to three cents per
pack, and this is several years ago.
So states have the authority to
set taxes at different levels. To give you a sense of the
magnitude of importance to a state’s budget the sales tax
represents, if California increased the
sales tax by only fifty cents, it would raise nearly a half a
billion dollars per year. If New York would increase
their taxes by about fifty cents,
they would increase their income, their revenue,
by about a third of a billion dollars per year.
So that states have become
quite highly reliant upon these sales taxes as an important form
of income. How about some of the
statistics about smoking prevalence in education?
So as I said at the beginning
of the lecture, about fifty million people out
of a few over three hundred million people in the United
States smoke. But what about their level of
education? And what you see is that
current smokers tend to decline as a percentage with education.
Less than high school,
you see here the current smoking rate is much higher than
it is for those that have a university education.
So that those that understand
the health effects are less likely to adopt tobacco use and
they’re more likely to consider quitting.
So to give you a sense also of
the magnitude of tax revenue across some of the larger
states, the U.S. income is now well over ten
billion dollars per year that states enjoy.
Tobacco also has been a target
for subsidy removal. So compared to corn as an
example, corn enjoys about a one and a half billion dollar
subsidy, or did in 2004,
whereas tobacco subsidies are less than a billion dollars
today. Advertising is a very important
component of the cigarette companies’ budgets,
so that they are spending today close to twenty-two billion
dollars on advertising and promotional expenses.
And this amounted to about
fifty-three dollars for every person in the United States.
This is a twenty-two percent
increase over previous years. So what you find is,
as the market goes down, as the adoption rate among the
young go down, they will vary their targeting
of advertising by gender, by ethnic group,
as well as by age. So that expenditures for
advertising have increased in response to an increase in
regulation and these declining adopting rates.
Targeting children through
advertising is an important thing to consider.
And kind of curiously,
children played an important role in the evolution of
prohibitive policy with respect to nuclear weapons.
They played an important role
in the control of lead. They played a really important
role in the adoption of the tougher particulate matter
standards for pesticide restrictions.
So that in this case,
recognition that children are especially susceptible to
persuasion by advertising has similarly led to recent more
restrictive legislation. So Joe Camel provides a pretty
interesting example. This series ran between 1988
and 1997. And about three thousand new
smokers less than eighteen years were picked up per day.
And about a third of these
people, if they persist in their habit, will die of
tobacco-related illness. The appeals are well known to
everybody. Here you see Joe Camel with a
woman, an attractive woman in the background.
The image is tough,
the image is one of a fighter pilot.
And there he is,
smoking his cigarette. The idea of this series was
modeled after a television show called Miami Vice,
really modeled after James Bond and Don Johnson.
And one study showed that
nearly a third of all three year olds matched the character to
the cigarette brand. And among six year olds,
Joe Camel was as familiar as Mickey Mouse.
So within a matter of three
years, Joe increased Camel’s market share from one to
thirty-three percent in the less than eighteen year old range.
Sales increased during that
three-year period by five hundred million dollars per
year. And this is believed now to be
one of the most successful advertising campaigns in
history. Now think about the imagery as
well. So here on the left-hand slide,
you see a woman having presumably just reached a
mountain peak and then reached into her pocket for a Lucky
Strike. The Marlboro Man,
also the image of masculinity riding a horse,
having just roped a steer, also a key symbol for the
corporation. Looking back in history,
you can see also the appeal to women, and particularly as a
weight control strategy. So “to keep a slender
figure, no one can deny it’s wise to reach for a Lucky.”
And also the appeal to keeping
mom on a steady course. So here you have a child in the
ad, “Before you scold me, Mom, maybe you’d better light
up a Marlboro.” And “Gee,
Mommy, you sure enjoy your Marlboro.”
So things seem happier in the
family. So somebody’s cranky and
associate the use of tobacco with a mood swing.
Physicians were enlisted to
support advertising as well. So here you see some ads from
the 1930s and 1940s. It’s actually interesting,
you can go back through these old volumes of Life Magazine
or National Geographic or Time Magazine over
in Sterling Library and take a look at the patterns in
advertising over time. So, “Twenty thousand,
six hundred and seventy-nine physicians say Luckies are less
irritating,” and “It’s toasted.”
“More doctors smoke Camels
than any other cigarette.” Dentists also were part of the
advertising game. Anybody that has smoked or
knows smokers know that cigarettes generally stain
teeth, especially those without filters.
So the idea that putting a
filter on the end of the tobacco could remove the dangerous
product, it could remove the discoloring
agents in the compound, that’s an interesting idea.
Santa Claus even got into the
act for a while. So “guard against throat
scratch.” There’s also a long history
about reliance on gender. And women have been extensively
targeted. Women tend to have lower
adoption rate than men do by four or five percent in the
United States. And the dominant marketing
strategy has been one to rest on themes of both social
desirability and independence. And these are normally conveyed
by thin, attractive, and athletic models.
This history goes back quite a
ways, and you see it in different parts of the world as
well. So that the highest estimates
for cigarette smoking among women tend to be in the southern
and tobacco-growing states, such as Kentucky,
where it’s about 28.1 percent. Whereas nationally,
only eighteen percent of women smoke.
Also, you can recognize certain
patterns of reliance of different brands on different
types of imagery. So whereas Marlboro
concentrated on kind of a machismo image of masculinity,
Virginia Slims instead concentrated their efforts on
women. Always slim women,
always tough women, “Yeah, I got a tattoo and
no, you can’t see it.” So the image of sexuality and
also strength dominated their imagery.
The tobacco companies also
tried to influence cultural acceptance of tobacco products
by encouraging actors to smoke on stage,
encouraging producers, providing subsidies so that
tobacco use was noted in about seventy-five percent of all
movies that were reviewed several years ago and
forty-three percent of the movies showed scenes in which
tobacco use could be interpreted as attractive,
with qualities described by teenagers as sexy,
exciting, powerful, cool, sophisticated,
rebellious, and celebratory. And twenty-five percent of the
movies included some of the anti-tobacco statements.
Top-billed actors lit up in
fifty-nine percent of all movies reviewed.
Another example of Virginia
Slims advertising. Riding a motorcycle.
The idea that you would take on
risks, not only riding a motorcycle, but also riding
without a helmet. So that the idea that you’re
tough, you’re attractive,
you’re slim, these are all images that are
very strategically designed to encourage adoption rates.
In different parts of the
world, you find different ethnic groups being targeted using a
variety of different strategies. So Virginia Slims also tried to
create the idea that independence and cultural pride
are linked to tobacco use. So that there’s a terrific
amount of variability. Also, the promotion of
different kinds of events. When I was a kid and we’d go to
rock concerts, people would commonly be there
with these big trays hung over their shoulders with
sample-sized tobacco packages, four or five cigarettes in a
carton, and they were given out freely.
In some bars,
the promotional activities also freely distributed tobacco
products. In this case,
you probably recognize or knew that different kinds of races
and athletic events were sponsored by different groups.
for example, was quite active in promoting
tennis tournaments. The Virginia Slims Invitational
is an example of that. NASCAR racing was promoted by
Lucky Strike. The Marlboro 500 is another
stock car race. My dad, when he was in World
War II, he would, after he came back,
he always told stories about his K-Ration Kit.
So that they were given
K-Rations, which often included Spam, but also peanuts and
chocolate bars. And he would tell about always
having a cigarette pack freely available to all the GIs.
What a brilliant advertising
technique, recognizing the addictive power
of tobacco, how few cigarettes it really
takes to cause a physical addiction,
and putting them into every K-Ration,
virtually ensuring that you would have a high addiction rate
among the GIs once the millions of soldiers came back to the
U.S. Today, if you look on the
internet, you’ll find a variety of different advertising schemes
in different parts of the world. RJR Stir the Senses campaign is
a good example. And some of them include
product auctions and encourage you to become a member so that
they can advertise and provide you with information about
different kinds of discounts on products as well as to promote
their products. Now, different countries too
have taken different approaches to labeling.
And you know that I’m not a
great fan of labeling as a way of conveying knowledge about
risk. And I don’t think that it
really often helps a consumer to understand the true benefits as
opposed to the adverse effects associated with products.
But the Canadians have taken a
tougher stance than we have in the United States.
Now in the U.S.,
you know that we have these little boxes on the sides of the
packets, or sometimes on the backs of
the packets, that may say “Warning:
This product is known to cause cancer,”
or “This product is dangerous to your health,”
or “This product causes emphysema or exacerbates
asthma.” So that there are a variety of
different signal phrases that are required to be cycled
through on the sides of tobacco products.
Canada has a system whereby
they demand that the front of the package include photographs
of health loss. So here’s an example of what a
heart looks like after it’s had an attack, the darker area,
for example, in this photo.
cigarettes cause lung cancer. So someone on a heart-lung
machine lying in a hospital. Cigarettes hurt babies,
so that an appeal to protection of the unborn and of children,
getting people to think more carefully about what they’re
doing to their young. And something that might wake
up teenagers, tobacco use can make you
impotent. Can make you impotent?
That’s news to many people.
There are also prevalence rates
that vary by ethnicity so that American Indians and Alaskan
natives, for example,
have adoption and prevalence rates that are far higher than
we have in other ethnic minorities.
And also, Asians have one of
the lowest adoption and addiction rates in the nation.
Most smokers begin as teens.
And this is quite interesting
to me when I saw this. David Kessler showed this slide
to me. I’m going to show a series of
slides that he provided when he used to lecture in this course.
And you see that the adoption
rates begin at a very young age, so that up to twelve,
thirteen percent occur beneath the age of twelve.
Beneath the age of fifteen,
you see roughly twenty-five, fifty, maybe about fifty
percent of the age of adoption. So that the target of youth has
become a very important aspect of advertising campaigns among
the tobacco companies. In fact, RJ Reynolds in 1984
stated that “young smokers had been the critical factor in
the growth and decline of every major brand and company over the
last fifty years.” So if you can addict a single
individual who is fifty years old,
you will have a much lower rate of return than you would if you
could addict a fifteen year old. Another comment by an RJ
Reynolds executive, “Realistically,
if our company is to survive and prosper over the long term,
we must get our share of the youth market.”
And speaking again,
the executive says: “Evidence is now available
to indicate that the fourteen to eighteen year old group is an
increasing segment of the smoking population.
RJR must soon establish a
successful new brand in this market if our position in the
industry is to be maintained over the long run.
If we are to attract a
nonsmoker or pre-smoker, there is nothing in this type
of product that he would currently understand or desire.
Instead, we somehow must
convince him with wholly irrational reasons that he
should try smoking.” Very interesting idea.
So here you have a product that
would be disgusting to many people that had never tried it.
I remember when I smoked my
first cigarette, I just coughed and sputtered,
my eyes watered, I hated the taste and I hated
the smell that I carried around. And so that this was well
recognized by the industry that they needed to create other
factors that would encourage people to adopt.
Now how about the legal
framework that this sits within? Well, the Surgeon General’s
report that was released in 1964 was the first thorough and
comprehensive indictment of the effect of tobacco products on
human health, concluding that it did induce
lung disease. So that the Federal Trade
Commission at that time began to regulate advertising.
And it concluded that cigarette
advertising was deceptive, that advertisers had a
responsibility to warn the public about the health hazards
of smoking, and that the Federal Trade
Commission then proposed labeling the amount of tar and
nicotine and include a statement such as “Caution:
Cigarette smoking is dangerous to health.
It may cause death from cancer
or other diseases.” The idea of preemption
originated with respect to tobacco products back in 1965.
And it prohibited the Federal
Trade Commission and States and local governments from requiring
any other label on cigarette packages and any warnings to
cigarette advertising at least until 1969.
There’s also the Federal
Communications Commission that plays an important role here,
particularly the Fairness Doctrine.
So by 1967, more money was
spent on television tobacco advertising than for any other
product. And in 1966,
a citizen, John Banzhaf, wrote to CBS TV in New York and
requested that some other responsible spokesperson be
given a chance to present contrasting views on the issue
of the benefits and advisability of smoking.
And the FCC responded and
required a significant amount of time to rebut tobacco
advertising, concluding that “We hold
that the Fairness Doctrine is applicable to such
advertisements.” The Fairness Doctrine has its
origin in 1949 in a rule that required broadcasters to devote
some of their air time to discussing controversial matters
of public interest and to air contrasting views regarding
those matters. In 1969, the Public Health
Cigarette Smoking Act was adopted, and it demanded a
cautionary label with a key change in the phrase.
So that “The Surgeon
General has determined that cigarette smoking is dangerous
to your health,” not “may be dangerous to
your health.” It also required a blackout of
cigarette commercials as of January 1971,
and television and radio stations estimated a loss of
about two hundred and twenty million dollars in revenue.
So recall that I argued that
this industry creates a very large revenue base for states.
It also created a terrific
revenue base in terms of advertising for the
communications industry. What this means is that the
industry support was quite varied and quite wide and
diverse, that the tobacco industry had
the capacity to go to Congress and find allies that would not
be immediately intuited. So about seven and a half
percent of their total advertising revenue had been
associated with the tobacco industry at the time.
advertising, and age restrictions between
1965 and 2008 became the key targets of Congress when they
enacted six different statutes. And they required that all
packaging have labels on it. They required that the
advertisement of tobacco products through any electronic
communication medium would be prohibited by the Federal
Communications Commission. And it also required,
these statutes required the Secretary of Health and Human
Services to report every three years to Congress on research
findings concerning tobacco’s addictive property.
Kind of curiously,
to combat the origin of the scientific studies occurring
predominately within the industry,
the National Institute of Health started funding
independent studies. So that just as you find in the
pharmaceutical industry or in the pesticide industry,
the conduct of independent science really became quite
important to the government’s capacity to mount a challenge to
the evidence that was presented by the industry itself.
Also, these statutes made
states, the receipt of certain federal block grants contingent
upon their prohibiting tobacco product manufacturer,
retailer, or distributor from selling these products that
included not just cigarettes but also cigars and chewing tobacco
to individuals under the age of eighteen.
So what are the estimated
health effects from tobacco? Irritation is well recognized.
Lower respiratory infections
were recognized early. Reduced lung function.
Increased risk for asthma and
exacerbation of asthma among those that had it previously.
Early onset of menopause.
Also environmental tobacco
smoke can cause brain tumors and cervical cancer.
That’s environmental tobacco
smoke, that’s not smoke that’s inhaled by the smoker.
There are really three
different kinds of smoke that a cigarette would produce.
One is the smoke that’s inhaled
through the tobacco itself as it burns.
The other would be what’s
called side-stream smoke that is given off by the burning tip of
the product. And the third would be the
smoke that’s exhaled. So each is a different complex
of compounds, between three and four thousand
different chemicals. So it’s really been a very
difficult task understanding which of these chemicals is
responsible for which of these health effects.
But this, it’s an interesting
problem. It’s similar in respect to
diesel emissions, which is also a complex
mixture, so that the effect of the mixture has been the subject
of study, as opposed to the analysis of
individual components in the mixture.
So exposure during pregnancy
harms the fetus, and synergistic effects exist
with radon, the natural gas that’s given
off by granitic rock that we have here in Connecticut,
and the combination is known to cause lung cancer.
Environmental tobacco smoke has
increasingly become a target of regulation.
And its relationship to heart
disease is well supported by about thirteen epidemiological
studies, now fourteen. Environmental tobacco smoke is
responsible for other kinds of effects that include heart
disease, impairment of platelet
function, damage to the inside lining of arteries,
interference with oxygen delivery and use by cells.
And it can also depress
cellular respiration and enhance fatty deposits on vessel walls
that can exacerbate cardiovascular and neurological
illnesses. In 1997, a Harvard study of
thirty-two thousand nurses was released,
and found that the relative risk of coronary heart disease
among those that smoked compared to those that did not was about
two. So there was a two-fold
increase of risk of heart disease among those that smoked.
And they attributed sixty
thousand additional deaths each year in the United States to
environmental tobacco smoke. So that it wasn’t until the
late 1990s that these estimates of health loss associated not
from smoking but being in an environment where others smoked
became quite sophisticated. A twenty-fold increase in death
from lung cancer was attributed to environmental tobacco smoke
as stated in EPA’s 1992 Passive Smoking Report.
William Riley was the
administrator of the Environmental Protection Agency
at that point in time and he also is a Yale graduate and
returns to Yale quite often. And I spoke to him about his
effort inside the Environmental Protection Agency in the early
1990s to have environmental tobacco smoke declared to be a
dangerous substance and more heavily regulated.
And he thought that that was
one of the most difficult fights that he had as administrator
during the early 1990s. The chemicals found inside
tobacco smoke are all chemicals that you’ll recognize as
hazardous substances. Carbon monoxide,
nicotine, carcinogenic tars, ammonia, nitrogen dioxide,
vinyl chloride, cyanide, formaldehyde,
radionuclides, benzene, nitrosamines,
aromatic hydrocarbons, benzoate, pyrene,
and arsenic, all of these compounds are the
target of regulation under different statues.
So it’s quite remarkable that
we’ve been allowed to burn cigarettes in indoor
environments. So why has indoor environmental
quality and this problem escaped the attention of the
Environmental Protection Agency? Well, it really has to do with
private property rights and the perception of being free from
government regulation inside your own home or inside your own
office. But it is quite curious.
The question about who should
pay for tobacco-related illness has prompted much more vigorous
regulatory action and really was the basis for David Kessler’s
initiative inside the Food and Drug Administration that you
read about in his book, Question of Intent.
So in 1994 a new law was passed
authorizing the state of Florida to sue cigarette manufacturers
to recover their Medicaid funds used to treat people that had
tobacco-related illnesses. So states began to recognize
that their expenditures to pay for these illnesses were
enormous. They were in the multiple
billion dollars per year. The law was upheld by the
Florida Supreme Court and as of 1997,
forty-one states banded together to sue the tobacco
industry to recover these Medicaid costs.
The state settlement,
as I mentioned earlier in the lecture, is estimated to be
about $250 billion. Additional private litigation
has also gone on in different states against different
corporations. States have also,
kind of interestingly, borrowed against their
anticipated tobacco payments. And many believe that states
have become addicted to the tobacco money produced as a
result. So the EPA, in 1990,
began attacking passive smoking as being causally associated
with lung cancer in adults. And it listed environmental
tobacco smoke as a group A, or a “known human
carcinogen.” You may think this is kind of a
modest difference in classification,
but there are relatively few known human carcinogens that are
recognized by the National Cancer Institute,
the Centers for Disease Control, the International
Agency for Research on Cancer, and the World Health
Organization. So that the listing of the
product as a known human carcinogen gave the government
an increased step that they could use to–
an increased and powerful lever that they could use to step up
their encouragement to prohibit tobacco products from being used
in public buildings. EPA estimated in 1992 that as
many as three thousand nonsmokers die from lung cancer
every year. There are different roles that
EPA has played. And if EPA has been responsible
for environmental tobacco smoke or second-hand smoke,
the FDA has been thought of as the target for regulation.
And that story is told,
I think very, very well by David Kessler.
So that FDA’s question really
surrounded two issues. One, whether or not nicotine is
considered to be a drug, because under the Food,
Drug, and Cosmetic Act, FDA eventually claimed
jurisdiction based upon its finding that nicotine was a
drug. And if so, then it needed to
receive a license from the Food and Drug Administration.
And the second question is,
under the statute, is a cigarette itself or a
cigar a drug delivery device for the drug?
And if yes, it should be
regulated and possibly prohibited under the statute.
So this question about
addiction is quite interesting. So if you look at a sales
weight in nicotine and tar levels in smoke,
back as early as 1982 you found that as a percentage of the 1992
level between ’82 and 1991, you find that the nicotine
levels in cigarettes increased. The tar levels went down,
predominately as a product of filtration.
But something was going on.
And what was driving this
increase in nicotine? In fact, curiously,
the amount of nicotine in light brands that emerged during the
’80s and the 1990s, were found to be higher than in
the regular brands. This didn’t seem to make much
sense. They also realized that if you
pluck the tobacco leaves higher up on the stalk,
that they had a higher nicotine content in some species of
plants. So that that meant that the
tobacco growers, the tobacco processors,
had the capacity to manipulate the nicotine level based upon
the location on the stalk that the leaf was plucked from.
So the question again that
faced the Food and Drug Administration was,
isn’t nicotine a drug? And here’s a comment from Sir
Charles Ellis, from the British American
Tobacco Company Research Conference in 1962.
“It’s my conviction that
nicotine is a very remarkable beneficent drug that both helps
the body to resist external stress and also can,
as a result, show a pronounced tranquilizing
effect. Nicotine is not only a very
fine drug (he continued), but the techniques of
administration by smoking has a considerable psychological
advantage and a built-in control against excessive absorption.
We are, then,
in the business of selling nicotine, an addictive
drug…” By the way, these were comments
made at a private and confidential conference that
were eventually disclosed by the Food and Drug Administration in
its discovery process. And you can read more about
that and the role that Deep Cough played in giving the Food
and Drug Administration, and particularly Kessler,
guidance in how to get access to some of this information that
was not in the public domain. He continued:
“We are of the conviction that the ultimate explanation
for the perpetuated cigarette habit resides in the
pharmacological effect of smoke upon the body of a smoker.
Think of a cigarette pack as a
storage container for a day’s supply of nicotine…think of
the cigarette as a dispenser for a dosed unit of nicotine…
think of a puff of smoke as the
vehicle for nicotine…smoke is beyond question the most
optimized vehicle of nicotine…”
So going back to these original
transcripts of meetings held within the tobacco industry,
Kessler felt that he had discovered yes,
they believed that this was a drug.
They believed that it was
addictive, and they were thinking themselves that the
cigarette and cigar wrappers were drug delivery devices.
“In a sense,
the tobacco industry may be thought of as a specialized,
highly ritualized, and stylized segment of the
pharmaceutical industry.” Again, this is Claude Teague.
“Tobacco products uniquely
contain and deliver nicotine, a potent drug,
with a variety of physiological effects.”
They also discovered that the
companies were engaged in plant breeding,
trying to genetically engineer strains of tobacco plants that
would produce higher levels of nicotine,
particularly a strain known as the Y1 nicotine strain.
So the percentage of nicotine
in Y1 was about three-fold the content of normal flue-cured
tobacco. And the ammonia,
they found was capable of liberating free nicotine from
the blend in which it was associated,
and it increased the impact of satisfaction.
So adding ammonia as a chemical
component of the tobacco product would increase the delivery of
nicotine. So I’m going to stop there.
We’re just about at time.
And we’ll come back to the more
recent revisions to law, particularly the statute that
was adopted last June, and signed by President Obama,
and compare that statute to the Food and Drug Administration’s
proposed regulations when Kessler was then the FDA
Commissioner. Thank you.