VOLUME
111
2001-2002
NUMBER
5
March 2002
-
Review
Tobacco Unregulated: Why the FDA Failed, and What To Do Now
111 Yale L.J. 1179 (2002)
The book jacket promises drama. David Kessler, former Commissioner of the Food and Drug Administration (FDA), is said to tell "a gripping detective story," a story of "right and wrong" and "moral courage." The "unlikely heroes" are a small team of FDA employees who set out to battle the "lethal" tobacco industry. Kessler himself plays a role akin to James Stewart's Mr. Smith.
This was real life, however, and the good guys did not win. Based on its investigations of the tobacco industry, the FDA answered the "question of intent"--whether tobacco manufacturers intended to produce nicotine's drug-like addictive effects--positively. This finding meant, for the FDA, that tobacco was a drug, and that tobacco therefore fell within its jurisdiction. The Agency acted on its claimed authority to promulgate rules aimed at reducing the incidence of youth smoking. These rules, for example, restricted underage purchases, prohibited billboard advertising near schools, and banned all but text-only ads in print publications that reach the young. The Supreme Court, however, taking the position that Congress did not intend to place tobacco within the Agency's jurisdiction, struck down the regulations.
Of course, the FDA's battle, despite its ultimate failure to create a regulatory scheme for tobacco, was not wholly without effect. Its investigation brought to light information about the mechanisms manufacturers use to control the level of nicotine in their products. Industry documents obtained by the Agency showed plainly how tobacco products are designed to "deliver nicotine, a potent drug, with a variety of physiological effects." The Agency's evidence demonstrated, as the Supreme Court observed, "that tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States." Collectively, the information produced through the FDA's investigation "changed popular thinking forever." The investigation also spurred a televised congressional hearing at which tobacco executives denied the addictive nature of cigarettes, a position that helped further to discredit the industry in the public mind. The Kessler-led effort, in short, has put tobacco reform on the public agenda in a way that promises continuing change.
Nevertheless, the fact remains that the FDA's regulatory effort failed. One aim of this Review is to explain why. I maintain that Kessler, perhaps driven by the sort of black-and-white dynamics that color the book jacket, sought too much. He claimed an essentially open-ended jurisdiction with unidentified aims. Had he argued for a more limited vision of the Agency's authority, one that, for example, confined itself to the youth smoking that was, in any case, the subject of the Agency's proposed regulations, the Supreme Court might have supported the Agency.
When he announced the regulatory effort, President Clinton stated that the "cigarette companies still have a right to market their product to adults. But today we are drawing the line on children." The restrictions promulgated by the FDA did indeed specifically target youth smoking. However, the FDA's jurisdictional claim, based on the addictive effects of nicotine in tobacco, was more sweeping. For Kessler, gaining jurisdiction "was far more important than" any rule, since any rule "was likely to be relatively modest, at least initially." The implication of this and other comments is that Kessler intended for the FDA eventually to regulate adult smoking and quite possibly to reduce nicotine levels in cigarettes generally. The breadth of the FDA's jurisdictional claim allowed the industry to raise the stakes of tobacco regulation to unacceptable levels. The industry argued that the Agency's findings on the harmful effects of nicotine would necessitate an absolute ban on the sale of tobacco products, but that such a ban was not intended by Congress. Whether the FDA could ever have regulated adult use of tobacco products is debatable, but if the Agency wanted to leave the issue open it should have done so in a way that made further regulation subject to independent judicial review, by, for example, framing its initial jurisdictional assertions in a way that precluded the possibility of any de facto ban. By arguing for open-ended authority, Kessler ironically allowed the tobacco industry to inject its own question of intent, one that looked not to the minds of the manufacturers but to the thinking of congressional lawmakers.
The first two Parts of the Review elaborate this thesis. Part I summarizes Kessler's account of the Agency's decision to take on tobacco and its search for evidence to support its jurisdictional claims. The summary points out the discoveries that the FDA made and highlights the ways in which Kessler designed the FDA's effort to regulate youth smoking as a sympathetic hook upon which to capture wide jurisdictional authority. Part II examines the Supreme Court decision that invalidated the FDA's rule. The Court's decision merits only brief mention in Kessler's discussion, which dismisses it as a straightforward outcome of conflicting ideologies. Whatever the Justices' motives, their opinions respond to basic questions about congressional intent and the scope of an agency's delegated authority. My analysis of the Court's opinion suggests that, given an agency's ability to adapt its legal powers to new circumstances in light of the statutory purpose of its enacting legislation, the FDA's youth-centered rule could have survived had the Agency argued for it on narrower jurisdictional grounds. In any case, the conflicting approaches expressed by the majority and the dissent regarding agency discretion, both generally and in the tobacco context, provide signposts for the FDA in determining its future role in the realm of tobacco regulation.
Part III considers directly the future of tobacco policy. Echoing the crusading chords of the book jacket, Kessler makes a stark proposal: He suggests that tobacco companies "be spun off from their corporate parents" and transferred to a congressionally chartered corporation that satisfies the industry's product liability obligations and sells tobacco in brown paper wrappers. If, as one tobacco lawyer suggested, the industry must now "obtain[] permission from society to continue to exist," Kessler seems unwilling to grant such permission. I argue that his approach is riddled by too many unknowns, and is also constitutionally problematic, since First Amendment protections of commercial speech ordinarily preclude a total restriction on product promotion.
Furthermore, the proposal ignores the advent of new types of risk-reduced tobacco products, "safer" cigarettes that may help those who cannot or will not quit smoking. A recent FDA-funded report by a committee of the Institute of Medicine (IOM) in the National Academy of Sciences found that these "reduced exposure" products could potentially be beneficial, if accompanied by an adequate regulatory scheme. Philip Morris, which is developing a smokeless cigarette, has also issued a new position paper acknowledging the need for legislation authorizing limited FDA regulation of tobacco. In the remainder of Part III, I argue that the FDA should be given regulatory authority over reduced-risk products. Moreover, even if no new authority is granted, the Agency's existing authority may by itself permit regulation. Although the Supreme Court rejected the FDA's broad jurisdictional claim, the Court was dealing with tobacco products generally, not with products specifically intended to reduce risk.
I conclude by suggesting that tobacco companies should have an obligation, because of tobacco's addictive nature, not only to reduce smokers' risk but also to assist smokers who wish to quit. Most promising would be industry development and marketing of cigarettes containing progressively lower quantities of nicotine as part of a graduated program of cessation. Measures such as this would restore to tobacco users the choice of which addiction robs them.
The book jacket promises drama. David Kessler, former Commissioner of the Food and Drug Administration (FDA), is said to tell "a gripping detective story," a story of "right and wrong" and "moral courage." The "unlikely heroes" are a small team of FDA employees who set out to battle the "lethal" tobacco industry. Kessler himself plays a role akin to James Stewart's Mr. Smith.
This was real life, however, and the good guys did not win. Based on its investigations of the tobacco industry, the FDA answered the "question of intent"--whether tobacco manufacturers intended to produce nicotine's drug-like addictive effects--positively. This finding meant, for the FDA, that tobacco was a drug, and that tobacco therefore fell within its jurisdiction. The Agency acted on its claimed authority to promulgate rules aimed at reducing the incidence of youth smoking. These rules, for example, restricted underage purchases, prohibited billboard advertising near schools, and banned all but text-only ads in print publications that reach the young. The Supreme Court, however, taking the position that Congress did not intend to place tobacco within the Agency's jurisdiction, struck down the regulations.
Of course, the FDA's battle, despite its ultimate failure to create a regulatory scheme for tobacco, was not wholly without effect. Its investigation brought to light information about the mechanisms manufacturers use to control the level of nicotine in their products. Industry documents obtained by the Agency showed plainly how tobacco products are designed to "deliver nicotine, a potent drug, with a variety of physiological effects." The Agency's evidence demonstrated, as the Supreme Court observed, "that tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States." Collectively, the information produced through the FDA's investigation "changed popular thinking forever." The investigation also spurred a televised congressional hearing at which tobacco executives denied the addictive nature of cigarettes, a position that helped further to discredit the industry in the public mind. The Kessler-led effort, in short, has put tobacco reform on the public agenda in a way that promises continuing change.
Nevertheless, the fact remains that the FDA's regulatory effort failed. One aim of this Review is to explain why. I maintain that Kessler, perhaps driven by the sort of black-and-white dynamics that color the book jacket, sought too much. He claimed an essentially open-ended jurisdiction with unidentified aims. Had he argued for a more limited vision of the Agency's authority, one that, for example, confined itself to the youth smoking that was, in any case, the subject of the Agency's proposed regulations, the Supreme Court might have supported the Agency.
When he announced the regulatory effort, President Clinton stated that the "cigarette companies still have a right to market their product to adults. But today we are drawing the line on children." The restrictions promulgated by the FDA did indeed specifically target youth smoking. However, the FDA's jurisdictional claim, based on the addictive effects of nicotine in tobacco, was more sweeping. For Kessler, gaining jurisdiction "was far more important than" any rule, since any rule "was likely to be relatively modest, at least initially." The implication of this and other comments is that Kessler intended for the FDA eventually to regulate adult smoking and quite possibly to reduce nicotine levels in cigarettes generally. The breadth of the FDA's jurisdictional claim allowed the industry to raise the stakes of tobacco regulation to unacceptable levels. The industry argued that the Agency's findings on the harmful effects of nicotine would necessitate an absolute ban on the sale of tobacco products, but that such a ban was not intended by Congress. Whether the FDA could ever have regulated adult use of tobacco products is debatable, but if the Agency wanted to leave the issue open it should have done so in a way that made further regulation subject to independent judicial review, by, for example, framing its initial jurisdictional assertions in a way that precluded the possibility of any de facto ban. By arguing for open-ended authority, Kessler ironically allowed the tobacco industry to inject its own question of intent, one that looked not to the minds of the manufacturers but to the thinking of congressional lawmakers.
The first two Parts of the Review elaborate this thesis. Part I summarizes Kessler's account of the Agency's decision to take on tobacco and its search for evidence to support its jurisdictional claims. The summary points out the discoveries that the FDA made and highlights the ways in which Kessler designed the FDA's effort to regulate youth smoking as a sympathetic hook upon which to capture wide jurisdictional authority. Part II examines the Supreme Court decision that invalidated the FDA's rule. The Court's decision merits only brief mention in Kessler's discussion, which dismisses it as a straightforward outcome of conflicting ideologies. Whatever the Justices' motives, their opinions respond to basic questions about congressional intent and the scope of an agency's delegated authority. My analysis of the Court's opinion suggests that, given an agency's ability to adapt its legal powers to new circumstances in light of the statutory purpose of its enacting legislation, the FDA's youth-centered rule could have survived had the Agency argued for it on narrower jurisdictional grounds. In any case, the conflicting approaches expressed by the majority and the dissent regarding agency discretion, both generally and in the tobacco context, provide signposts for the FDA in determining its future role in the realm of tobacco regulation.
Part III considers directly the future of tobacco policy. Echoing the crusading chords of the book jacket, Kessler makes a stark proposal: He suggests that tobacco companies "be spun off from their corporate parents" and transferred to a congressionally chartered corporation that satisfies the industry's product liability obligations and sells tobacco in brown paper wrappers. If, as one tobacco lawyer suggested, the industry must now "obtain[] permission from society to continue to exist," Kessler seems unwilling to grant such permission. I argue that his approach is riddled by too many unknowns, and is also constitutionally problematic, since First Amendment protections of commercial speech ordinarily preclude a total restriction on product promotion.
Furthermore, the proposal ignores the advent of new types of risk-reduced tobacco products, "safer" cigarettes that may help those who cannot or will not quit smoking. A recent FDA-funded report by a committee of the Institute of Medicine (IOM) in the National Academy of Sciences found that these "reduced exposure" products could potentially be beneficial, if accompanied by an adequate regulatory scheme. Philip Morris, which is developing a smokeless cigarette, has also issued a new position paper acknowledging the need for legislation authorizing limited FDA regulation of tobacco. In the remainder of Part III, I argue that the FDA should be given regulatory authority over reduced-risk products. Moreover, even if no new authority is granted, the Agency's existing authority may by itself permit regulation. Although the Supreme Court rejected the FDA's broad jurisdictional claim, the Court was dealing with tobacco products generally, not with products specifically intended to reduce risk.
I conclude by suggesting that tobacco companies should have an obligation, because of tobacco's addictive nature, not only to reduce smokers' risk but also to assist smokers who wish to quit. Most promising would be industry development and marketing of cigarettes containing progressively lower quantities of nicotine as part of a graduated program of cessation. Measures such as this would restore to tobacco users the choice of which addiction robs them.