title: The FDA may not regulate tobacco products as "drugs" or as "medical devices".
abstract: Professor Richard Merrill contends that the Federal Food, Drug, and Cosmetic Act does not grant the FDA regulatory authority over cigarettes and smokeless tobacco products.  The fact that Congress did not expressly deny the FDA regulatory authority over tobacco cannot, Professor Merrill argues, be used to infer such authority.  This inference is particularly inappropriate in the case of tobacco regulation, he maintains, because there is compelling evidence that Congress had no intention of delegating this authority to the FDA.  He is unpersuaded that presidential approval legally sanctions the FDA's claim of authority by granting it a superficial political legitimacy.  Finally, he reminds us of the FDA's own repeated denials of jurisdiction over tobacco products, and he recalls the numerous times that Congress passed legislation directed at tobacco without granting the FDA any role in its regulation.  Professor Merrill's Essay, like the other pieces in this volume, was written after the United States District Court for the Middle District of North Carolina decided Coyne Beahm v. FDA, but before a three judge panel of the United States Court of Appeals for the Fourth Circuit reversed that decision in Brown & Williamson Tobacco Corp. v. FDA. In Coyne Beahm, the District Court held that the Federal Food, Drug, and Cosmetic Act authorized the FDA to regulate tobacco products, but not tobacco advertising.  The Fourth Circuit rejected the District Court's jurisdictional ruling and invalidated the FDA's regulations in their entirety.  The Clinton Administration has since requested an en banc rehearing before the Fourth Circuit.
authors.affiliation: University of Virginia, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Merrill
mesh_terms: D000329:Advertising / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D006801:Humans; D010947:Plants, Toxic; D014026:Nicotiana; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence