title: The legal and scientific basis for FDA's assertion of jurisdiction over cigarettes and smokeless tobacco.
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.
authors.affiliation: US Food and Drug Administration, US Department of Health and Human Services, Rockville, Md. 20857, USA.
authors.forename: D A
authors.initials: DA
authors.lastname: Kessler
authors.forename: P S
authors.initials: PS
authors.lastname: Barnett
authors.forename: A
authors.initials: A
authors.lastname: Witt
authors.forename: M R
authors.initials: MR
authors.lastname: Zeller
authors.forename: J R
authors.initials: JR
authors.lastname: Mande
authors.forename: W B
authors.initials: WB
authors.lastname: Schultz
mesh_terms: D005731:Ganglionic Stimulants / Q000494:pharmacology*; D006801:Humans; D007880:Legislation, Drug; D009538:Nicotine / Q000494:pharmacology*; D010947:Plants, Toxic; D011050:Policy Making; D000074606:Smoking Prevention; D019460:Tobacco Industry / Q000331:legislation & jurisprudence; D014029:Tobacco Use Disorder / Q000517:prevention & control; D014030:Tobacco, Smokeless; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D005731:Ganglionic Stimulants; D009538:Nicotine