FDA v. Brown & Williamson
Tobacco Corp.
529 U.S. 120 (2000)
Docket Number: 98-1152
Abstract
Argued:
December 1, 1999
Decided:
March 21, 2000
Subjects:
Economic Activity: Consumer Protection
Facts of the Case
he Food, Drug, and Cosmetic Act (FDCA) grants the Food and Drug
Administration (FDA) the authority to regulate, among other items, "drugs"
and "devices." In 1996, the FDA asserted jurisdiction to regulate tobacco
products, concluding that, under the FDCA, nicotine is a "drug" and
cigarettes and smokeless tobacco are "devices" that deliver nicotine to the
body. Accordingly, the FDA promulgated regulations governing tobacco
products' promotion, labeling, and accessibility to children and adolescents.
Brown & Williamson Tobacco Corporation, and a group of tobacco
manufacturers, retailers, and advertisers, filed suit challenging the FDA's
regulations. Brown moved for summary judgement on the ground that the
FDA lacked the jurisdiction to regulate tobacco products as customarily
marketed, or without manufacturer claims of therapeutic benefit. The
District Court ruled that the FDA had jurisdiction over tobacco as a device,
but that the agency had overstepped its authority in attempting to restrict
tobacco advertising. In reversing, the Court of Appeals held that Congress
had not granted the FDA jurisdicti
on to regulate tobacco products. The court
found that the FDA's definition of tobacco as a device was flawed because
the agency could not prove that the impact of tobacco products on the body
was "intended" under the act.
Question Presented
Does the Food and Drug Administration have the authority to regulate
tobacco products as "drugs" and "devices" under the Food, Drug, and
Cosmetic Act?
