The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
these regulatory schemes. If tobacco products were included, each of these statutes would require extensive regulation of tobacco products to reduce risks to the health and safety of users and nonusers, including changes in product design and mandatory disclosure of information regarding contents and hazards. Moreover, under most of these schemes, faithful adherence to the statutory criteria would authorize, or even require, the regulatory agencies to take tobacco products off the market. For example, the chronic risk of tobacco products is much greater than the hazards of other products that have been banned under the Consumer Product Safety Act, and the Consumer Product Safety Commission's priority-setting rule suggests that it would have no choice but to ban tobacco products as well.
An analogous problem arises under the Food, Drug, and Cosmetic Act (FDCA). The definition of "drug" in the FDCA includes "articles (other than food) intended to affect the structure or any function of the body of man." Although the act does not expressly exclude tobacco products from its coverage, the Food and Drug Administration (FDA) has long taken the position that tobacco products manufactured and sold to be used "for smoking pleasure" are not "drugs" under the FDCA and are not subject to regulation thereunder, in the absence of intent by the manufacturers or vendors of cigarettes to affect the structure or function of the body. This position was ratified by the courts and has become the settled understanding.3
The FDA has not declined to exercise jurisdiction over tobacco products in all cases. The FDCA's definition of drug also includes articles "intended for use in the cure, mitigation, or prevention of disease," and the FDA has asserted jurisdiction when manufacturers have expressly promoted cigarettes as beneficial to health. For example, during the 1950s, the agency took regulatory action against cigarettes advertised as effective in preventing respiratory and other diseases4 and cigarettes promoted as weight-reducing aids.5 The FDA has also exercised jurisdiction over cigarette additives promoted as mitigating disease and over nicotine delivery systems promoted as alternatives to conventional cigarette smoking or as aids to smoking cessation. In recent years, petitions have been filed seeking to invoke FDA jurisdiction over cigarettes promoted as being "light" or otherwise low in tar and nicotine on the basis that these assertions imply that the cigarettes are less dangerous than other cigarettes and less likely to result in dependence or disease. The FDA has not yet acted on these petitions.
On February 25, 1994, FDA Commissioner David Kessler indicated that the agency was reconsidering its traditional view that tobacco products are not "drugs" under the FDCA. In a letter to the Coalition for Smoking OR Health and in subsequent testimony on Capitol Hill, Dr. Kessler sought to focus attention on whether cigarettes and other tobacco products are marketed as "nicotine delivery systems" to satisfy the dependence of consumers on nicotine. In raising this question, Dr. Kessler referred to evidence that "manufacturers commonly add nicotine to cigarettes to deliver specific amounts of nicotine."6 (As was