Analysis Regarding The Food and Drug Administration's Jurisdiction Over Nicotine-Containing Cigarettes and Smokeless Tobacco Products

Résumé

The Food and Drug Administration (FDA) is publishing a document entitled ``Nicotine In Cigarettes And Smokeless Tobacco Products Is A Drug And These Products Are Nicotine Delivery Devices Under the Federal Food, Drug, and Cosmetic Act,'' and announcing the availability of appendices to this document. FDA has conducted an extensive investigation and has engaged in comprehensive analysis regarding the agency's jurisdiction over nicotine-containing cigarettes and smokeless tobacco products. The results of that inquiry and analysis support a finding at this time that nicotine in cigarettes and smokeless tobacco is a drug, and that these products are drug delivery devices within the meaning of the Federal Food, Drug, and Cosmetic Act. Nonetheless, because the agency recognizes the unique importance of the jurisdictional issue as well as the factual justification for any proposed rule in this area, the agency invites comment on these matters. Comments submitted will receive full and serious consideration.