FDA v. Brown & Williamson Tobacco Corp

FDA v. Brown & Williamson Tobacco Corp.,
No. 98-1152 (U.S. Sup. Ct. Mar. 21, 2000)

The Food and Drug Administration (FDA) has statutory
authority to regulate both “drugs” and
“devices” under the Food, Drug, and
Cosmetic Act (FDCA), 21 U. S. C. §301 et seq. In
1996, the FDA claimed that it had jurisdiction to
regulate tobacco products, based on reasoning that
nicotine is a “drug” and cigarettes and
smokeless tobacco are the “devices” that
deliver nicotine to the body thereby giving the
agency the authority to regulate the tobacco
industry.

The Supreme Court concluded that the FDA did not
have jurisdiction to regulate tobacco products. The
Court said that if the FDCA were construed to
include tobacco products, it would lead to several
internal inconsistencies in the Act. It also found
that, before 1995, the FDA consistently stated that
it lacked jurisdiction over tobacco, that Congress
has enacted several tobacco-specific statutes on the
basis of the FDA’s stated position, and that
Congress has considered and rejected many bills that
would have given the agency such authority. The
Court held that considering the FDCA as a whole, in
conjunction with Congress’ subsequent
tobacco-specific legislation, Congress has not
granted the FDA the authority to regulate tobacco
products.