EVST 255: Environmental Politics and Law

Lecture 15

 - The Tobacco Paradigm


The lecture explores the development of scientific proof of the harm that tobacco poses to human health and the legal tools used to regulate its use. The government has used warnings, control over advertising, and age restrictions to regulate tobacco. The tobacco industry has been able to complicate efforts to impose stricter regulations on tobacco consumption due to its power in the media due to ad sales and government due to the importance of cigarette sales taxes to state governments.

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Environmental Politics and Law

EVST 255 - Lecture 15 - The Tobacco Paradigm

Chapter 1. Legal Strategies to Regulate Tobacco Use [00:00:00]

Professor John Wargo: 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. For example, 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.

Chapter 2. Targeting and Advertising Trends [00:11:49]

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. Virginia Slims, 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.

Chapter 3. Problematic Adoption and Prevalence Rates [00:21:29]

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. Another example, 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.

Chapter 4. An Evolving Legal Framework [00:25:47]

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.

So warnings, 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. Nonrespiratory cancers. 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 [correction: nonsmokers living with smokers] 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.

Chapter 5. Isn’t Nicotine a Drug? [00:37:48]

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 [the tobacco industry] 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.

[end of transcript]

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