Regulation Redux: Still a bad prescription for smoker’s health

Author: John Luik
Article Published: 25/07/2007

With the Democrats once again in control of Congress, the issue of the Food and Drug Administration regulation of the tobacco industry is very much back on the legislative agenda. Unfortunately, the legislation being offered this time round by Senators Kennedy (D), Cornyn (R)and Representatives Davis (R) and Waxman ( D) is essentially the same as that proposed three years ago when the idea of FDA regulation was linked to legislation on tobacco quotas.

The campaign to bring the tobacco industry under the regulatory authority of the FDA began three decades ago with a 1977 ASH petition to the agency asking it to assert its jurisdiction over cigarettes on the grounds that they were a drug. Rebuffed by the FDA, ASH brought suit in federal court seeking to overturn the administration’s decision, but the suit failed.


It was only with David Kessler’s arrival as FDA commissioner that the issue of FDA regulation of the industry was revived through the novel claim in 1996 that the industry not only manipulated nicotine levels, but that this manipulation was “intended” to affect the smoker’s body and together this meant that cigarettes were effectively drugs subject to FDA regulation.


Kessler who believed that the key to tobacco control was to be found in preventing youth smoking, proposed a series of regulations which focused on youth access to tobacco and tobacco marketing, and included sweeping restrictions on young people’s access to tobacco products and a virtual elimination of tobacco marketing that could be construed in any way to influence young people.


Challenged by the industry in court, the FDA eventually lost its bid for regulatory authority when the Supreme Court in 2000 rejected its claim that the industry’s marketing claims implicitly acknowledged that it was selling a drug. Writing for the court, Justice O-Connor concluded that if Congress had wished to provide the FDA with authority to regulate tobacco it would have done so in the relevant legislation. The Kennedy and Co legislation is an attempt to provide that relevant legislation.


At a Capitol Hill news conference announcing the legislation, the curiously titled  Family Smoking Prevention and Tobacco Control Act, Kennedy said that “Congress cannot in good conscience allow the federal agency most responsible for protecting the public health to remain powerless to deal with the enormous risks of tobacco, the most deadly of all consumer products.”  


So just why is the revival of the legislation aimed at giving the FDA regulatory over the tobacco industry unfortunate? The proposal is unfortunate for two reasons: first because of the FDA’s regulatory philosophy and its deep links to the prohibitionists in the anti-tobacco movement and second because of the specific features of the bill.


To begin with there is the general problem of the FDA’s regulatory philosophy about tobacco. There is little evidence that even after Kessler’s departure the FDA has moved on from his belief that the goal of tobacco regulation was not to prod the industry and its customers into developing, producing and consuming less risky products, but rather to provide the agency with a cudgel big enough to destroy the industry. In effect, the problem with FDA regulation is that it is not at all clear that this agency does not see regulation as the route to effective prohibition.


For instance, at the end of his memoir on his time at the FDA ( A Question of Intent, 2001), Kessler observes that “My understanding of the industry’s power finally forced me to see that, in the long term, the solution to the smoking problem rests with the bottom line, prohibiting the tobacco companies from continuing to profit from the sale of a deadly, addictive drug. If public health is to be the centerpiece of tobacco control… the tobacco industry, as currently configured, needs to be dismantled.” (p. 392) That sounds much less like regulation than prohibition.


Kessler’s views are by no means unique, either in their extremity or in their wrong-headedness. Anti-tobacco activists have recently advocated the nationalization of the tobacco industry in Canada, in order to allow the public health community to produce tobacco products that smokers will not wish to consume, and there have also been increasing calls for a total prohibition of tobacco.


For these zealots the major success of the last fifty years in tobacco control –dramatically fewer smokers smoking cigarettes with substantially reduced tar levels- has not been brought about by providing smokers with information about the risks of smoking but instead through vigourous government regulations about smoking in public places, increased taxes, and denormalization campaigns. For these anti-tobacco crusaders the focus of tobacco control has always been the creation of a smoke-free utopia- not by the decision of individuals deciding not to smoke, but through the coercive power of government. And while Kessler might no longer be at the FDA, many of the true believers in the smoke-free society still are, as well as being close by, and there is no evidence that they would not use their new found “regulatory” powers to begin a process of prohibition by stealth.


Such a prohibitionist agenda founders, however, on a number of stubborn facts. For instance, the FDA’s belief in the efficacy of advertising bans to prevent youth smoking or even substantially reduce it is contradicted by the fact that smoking has flourished in societies without any advertising and continues and indeed has increased in some countries which have had advertising bans for years.


Again there is considerable evidence that shows that the predisposition of youth people to risk-taking and the existence of cigarettes will always result in some youth smoking. Similarly, the way in which cigarettes, and not just nicotine satisfy a variety of needs for many people means that there will also always be adult smokers. And if there are smokers, the needs of these smokers together with the immense profitability of the tobacco market will continue to insure that entrepreneurs, whatever their legitimacy, will wish to serve that market. All of these things count against an effective prohibition of cigarettes and smoking.


But it is more than just the FDA’s prohibitionist tendencies that count against the new legislation, it is also what the legislation proposes to allow the FDA to do. Indeed, in this respect the Kennedy legislation gets tobacco control wrong at every turn in that it proposes a policy of not only ineffective but counterproductive measures that will do nothing to address the legislation’s primary concern- underage smokers.


First, the legislation is driven by the assumption that “tobacco advertising and marketing contributes significantly to the use of nicotine-containing tobacco products by adolescents.” Indeed, as Kennedy put it at the news conference introducing the legislation “The tobacco industry currently spends over $ 15 billion a year to promote its products. Much of that money is spent in ways designed to tempt children to start smoking.” (NYT 16/2/07) While such talk is at least understandable if not acceptable as a politician’s sound-bite, it is however a travesty as policy. For one thing there is a wealth of econometric evidence that disproves the claim that tobacco advertising either leads to smoking initiation or increased consumption. Indeed, most studies of youth smoking do not even focus on advertising as a major predictor of smoking uptake. Further, despite claims like Kennedy’s the Government was unable during its recent racketeering trial to produce any credible evidence that showed a causal link between tobacco advertising and young people becoming smokers, or indeed, that proved Kennedy’s claim that tobacco advertising is “designed to tempt children to start smoking.” Most importantly, the focus on advertising is a distraction which diverts attention away from the wealth of research which shows that the most reliable predictors of whether a young person will become a smoker are factors such as living in single parent home, living in poverty, and dropping out of school.


Then too there is the additional problem that advertising restrictions bring with their risk of freezing market share as well as making difficult the entry of new players in a market already over half owned by Philip Morris. While PM claims that it supports FDA regulation because of its commitment to “reasonable regulation”, a position driven at least in part by its desire to use regulation as a means to reposition itself as a normal and responsible business, a less flattering reading sees anti-competitive reasons as the real driving force behind the industry giant’s support for FDA regulation. Indeed it is hard to see just how FDA regulation restores industry legitimacy since the regulation could more naturally be seen as a sanction imposed for  past and continuing misconduct.


Second, the proposed legislation provides the FDA authority to ban terms like light and mild on the spurious grounds that such cigarettes do not provide a genuine health benefit to smokers. As we have argued before, there is considerable epidemiological evidence that reductions in tar levels since the 1940’s- from 46 mg average to about 12 mg in the 1990’s- have resulted in substantial reductions in lung cancer risks- reductions of 20-30%. This is true even with compensation, which much evidence shows to not be a significant issue for most smokers. It is difficult to see how a measure that would result in banning such descriptors could plausibly be construed as a health measure.


Third, the Kennedy legislation allows the FDA to reduce nicotine levels, as well as giving it control over cigarette ingredients-both unsound policy options. For one thing, Senator Kennedy and his colleagues appear not to have read the Institute of Medicine’s 2001 report which noted the importance of “retaining nicotine at pleasurable or addictive levels while reducing the more toxic components of tobacco…” (p. 29) Or maybe they have and understand its implications all too well.


By mandating reduced nicotine levels, the FDA can gradually make legal cigarettes less palatable, thus furthering not a harm reduction strategy but a prohibition by regulation strategy. The goal is not safer smoking- whatever the rhetoric- but no smoking, with nicotine reductions being the key tool to make smoking unattractive. Since smokers smoke in part for nicotine, reducing nicotine will drive determined smokers to either smoke more cigarettes or smoke black market cigarettes with traditional nicotine levels, neither of which benefits their health.


Equally dangerous is the move to give the FDA authority over cigarette ingredients since once again this appears to be nothing more than prohibition by stealth since it is an attempt to re-engineer cigarettes to make them unsmokeable rather than attempting to develop less risky products. One can already see where this is leading in the moves by the proponents of the FCTC to discover whether brand ingredient differences are linked to brand sales so that popular ingredients can be banned. 


Fourth, the move toward changed warnings- particularly graphics- envisioned in the legislation, offers little prospect of providing a genuine health benefit since graphic health warnings have been shown not only to be ineffective in reducing smoking initiation, consumption and prevalence but also have the potential to increase smoking in reactant smokers. For instance, the results of an extensive survey for the Government of Canada, found that graphic warnings in Canada had


·          failed to produce a statistically significant decline in the incidence of adolescent smoking;

·          failed to produce a statistically significant decline in adolescent consumption- indeed one year after their introduction occasional adolescent consumption was higher than before;

·          failed to produce a statistically significant change in adult prevalence or consumption;

·          led to a decrease in the number or adult smokers who looked at the warnings several times a day;

·          led to an increase in the number of both smokers and nonsmokers who never look at or read the warnings. (For a fuller discussion of the problems of graphic warnings see my A Picture of Health? Why Graphic Health Warnings Don’t Work Democracy Institute, 2006)


Finally, the legislation’s provisions that would vest final authority on the development of less risky tobacco products with the FDA are ill-considered since it is unclear that the FDA is genuinely interested in harm reduction. For example, it has never embraced the IOM report, despite the fact that it commissioned it. Moreover, a good portion of the anti-tobacco movement has actively opposed harm reduction because of its implications for prohibition. Indeed, this provision seems far more intended to eliminate the prospect of harm reduction than to enhance it since it places harm reduction under the control of an agency whose authority is to be deployed much more toward eliminating smoking, not making it safer. Thus while the legislation purports to allow reduced risk products, what it really suggests is a regulatory environment and agenda that is profoundly hostile to them. Allowing for the gradual reduction of nicotine combined with banning descriptors such as light and mandating graphic health warnings which do not convey accurate information about the risks of smoking, signals a policy agenda designed to stop smoking, not to allow smokers who wish to continue to smoke with greater safety.


A much sounder policy would be to create a regulatory philosophy and framework that would allow, indeed encourage vigourous competition to create innovative, reduced tar products and which ensures that individuals who choose to smoke have the best available information about the relative health risks of these products.


Both the tobacco industry and its customers could benefit enormously from an FDA regulatory framework that takes into account the realities of smoking in the United States as opposed to some smoke-free utopia, and is interested in the public health needs of the millions of Americans who continue to smoke. The “Family Smoking Prevention and Tobacco Control Act, a legacy of Dr. Kessler’s time at the DFA, is very sadly not that framework.

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