THE LEGAL AND SCIENTIFIC BASIS FOR FDAS ASSERTION OF JURISDICTION OVER CIGARETTES AND SMOKELESS TOBACCO

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 affec t the structure or any function of the body.'' The FDA determined that nicotine in cigarettes and smokeless tobacco does ''affect the struct ure or any function of the body'' because nicotine causes addiction an d other pharmacological effects. The FDA then determined that these ph armacological effects are ''intended'' because (1) a scientific consen sus has emerged that nicotine is addictive; (2) recent studies have sh own that most consumers use cigarettes and smokeless tobacco for pharm acological purposes, including satisfying their addiction to nicotine; and (3) newly disclosed evidence from the tobacco manufacturers has r evealed that the manufacturers know that nicotine causes pharmacologic al effects, including addiction, and design their products to provide pharmacologically active doses of nicotine. The FDA thus concluded tha t cigarettes and smokeless tobacco are subject to FDA jurisdiction bec ause they contain a ''drug,'' nicotine, and a ''device'' for deliverin g this drug to the body.