SW Legal Educational Publishing

FDA Does Not Have Authority to Regulate Tobacco
Description The Supreme Court struck down FDA regulations of tobacco products, holding that Congress has clearly intended, via numerous statutes, to allow tobacco to be sold subject to specific regulatory controls. The FDA cannot claim jurisdiction over tobacco when Congress has assumed direct regulatory control itself.
Topic Consumer Protection
Key Words FDA, Drug Delivery Devices, Tobacco
C A S E   S U M M A R Y
Facts The FDA asserted jurisdiction to regulate tobacco products, contending that under the Food, Drug and Cosmetic Act (FDCA), nicotine is a "drug" and that cigarettes and smokeless tobacco are "devices" that deliver nicotine to the body. The FDA then issued various regulations to restrict tobacco promotion, labeling, and access. Tobacco makers, retailers and advertisers sued to challenge FDA jurisdiction under the FDCA. The district court upheld the FDA action; the appeals court reversed. The FDA appealed.
Decision Affirmed. Reading the FDCA as a whole, and taking into account subsequent tobacco-specific legislation, it is plain that Congress has not given the FDA authority to regulate tobacco products as customarily marketed. The FDA has clearly documented that tobacco products are unsafe, dangerous, and cause illness and death. Hence, if tobacco were drug devices under the FDCA, the FDA would be required to ban them from the market, a position the FDA has expressed in the past-if tobacco were subject to FDA regulation. Congress has foreclosed a ban of tobacco products, choosing instead to create a distinct regulatory scheme, by numerous statutes, focusing on the labeling and advertising of tobacco products. Its express policy is to allow tobacco to be sold subject to specific rules. The FDA must defer to the regulatory intent of Congress.
Citation Food and Drug Administration v. Brown & Williamson Tobacco Corp., 120 S.Ct. 1291 (2000)

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