The legal and scientific basis for FDA's assertion of jurisdiction over cigarettes and smokeless tobacco
D. A. Kessler, P. S. Barnett, A. Witt, M. R. Zeller, J. R. Mande and W. B. Schultz
US Food and Drug Administration, US Department of Health and Human Services, Rockville, Md. 20857, USA.
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.
