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David A. Kessler, MD; Philip S. Barnett, JD; Ann Witt, JD; Mitchell R. Zeller, JD; Jerold R. Mande, MPH; William B. Schultz

JAMA. 1997;277(5):405-409.

Abstract
On August 28,1996, the US Food and Drug Administration (FDA) asserted jurisdiction over cigarettes and smokeless tobacco under the Federal Food, Drug, and Cosmetic Act. Under this Act, a product is a "drug" or "device" subject to FDA jurisdiction if it is "intended to affect the structure or any function of the body." The FDA determined that nicotine in cigarettes and smokeless tobacco does "affect the structure or any function of the body" because nicotine causes addiction and other pharmacological effects. The FDA then determined that these pharmacological effects are "intended" because (1) a scientific consensus has emerged that nicotine is addictive; (2) recent studies have shown that most consumers use cigarettes and smokeless tobacco for pharmacological purposes, including satisfying their addiction to nicotine; and (3) newly disclosed evidence from the tobacco manufacturers has revealed that the manufacturers know that nicotine causes pharmacological effects, including addiction, and design their products to provide pharmacologically active doses of nicotine. The FDA thus concluded that cigarettes and smokeless tobacco are subject to FDA jurisdiction because they contain a "drug," nicotine, and a "device" for delivering this drug to the body.

Author Affiliations
From the US Food and Drug Administration, US Department of Health and Human Services, Rockville, Md.

Footnotes
Reprints: David A. Kessler, MD, US Food and Drug Administration, 5600 Fishers Ln, 14-71 PKLN, Rockville, MD 20857.

Health Law and Ethics section editors: Lawrence O. Gostin, JD, the Georgetown/ Johns Hopkins University Program on Law and Public Health, Washington, DC, and Baltimore, Md; Helene M. Cole, Contributing Editor, JAMA.

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