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At a press conference held on August 23, 1996, just one year after initially revealing his plans, President Clinton announced sweeping federal regulations to combat the underage use of tobacco products. The Food and Drug Administration (FDA) subsequently published a lengthy preamble to accompany the final regulations, detailing the Agency's assessment of the problem and responding to numerous public comments to its notice of proposed rulemaking (NPRM). Characterizing the growing use of tobacco products as a "pediatric disease," FDA Commissioner David Kessler previously had vowed to alter the smoking habits of the newest generation of tobacco users in order to "radically reduce the incidence of smoking-related death and disease." This Article critically evaluates claims that the FDA has exceeded statutory and constitutional limitations on its power.

The tobacco regulations deal with both cigarettes and smokeless tobacco products, and they focus primarily on the advertising, sale, and distribution of these products to children and adolescents. Among other things, the regulations establish a federal minimum age for the purchase of tobacco products, prohibit some vending machine sales, and limit the format and content of, as well as the conditions under which minors are exposed to, tobacco product advertising. The Agency also plans to require that the tobacco industry undertake a substantial educational program aimed at minors to provide information about the harmful consequences of using tobacco products and to counteract the appealing images associated with tobacco use in recent advertising campaigns.

Part II focuses on objections to the Agency's claim that it can regulate the advertising of tobacco products using the special statutory provisions applicable to restricted medical devices. The FDA argues that nicotine qualifies as a drug because tobacco companies intend that consumers become addicted to nicotine containing products. Even if true, the Agency still must justify the assertion of authority over products traditionally regulated by another agency, and then it must explain the counterintuitive classification of tobacco products as medical devices, and also as restricted devices, rather than as drugs.

Part III canvasses some of the apparently unanticipated consequences of this device classification, including the possibility that cigarette manufacturers may enjoy a broader preemption defense in tort lawsuits. Finally, Part IV addresses the relative strength of some of the various constitutional objections raised by the industry, particularly with regard to the advertising restrictions and the proposed industry-financed educational campaign. Ultimately, this Article concludes that the FDA regulations exceed the Agency's delegated authority and that the proposed educational campaign contravenes the First Amendment.

Recommended Citation

48 Ala. L. Rev. 1 (1996)