Government Regulation -- 2000



FDA v. Brown & Williamson Tobacco Corp.   (U.S. Supreme Court)

Whether FDA has jurisdiction to regulate tobacco products

On 3/21/00, the Supreme Court held that Congress has not given the Food and Drug Administration authority to regulate tobacco products marketed without manufacturer claims of therapeutic benefit. In 1996 the FDA had asserted such authority and promulgated regulations governing tobacco products’ promotion, labeling, and accessibility to children and adolescents. In holding that the FDA lacked authority to issue these regulations, the Court noted that if tobacco products were subject to the FDA’s jurisdiction, the FDA would be required to ban them pursuant to the Food, Drug, and Cosmetic Act because they cannot be used safely for any therapeutic purpose. Congress, however, has foreclosed a ban of such products, choosing instead to create a distinct regulatory scheme for tobacco that focuses upon labeling and advertising. Accordingly, the Court concluded there was no room for tobacco products within the FDCA’s regulatory scheme. The Court also noted that, prior to 1996, the FDA had consistently stated that it lacked authority to regulate tobacco products as customarily marketed and that this longstanding interpretation had been ratified by Congress, which had enacted numerous statutes regulating tobacco directly and had on several occasions rejected bills that would have given the FDA regulatory authority over tobacco. Under the circumstances, the Court concluded that the FDA’s assertion of regulatory authority was not entitled to deference.