American Journal of Law & Medicine

Supreme Court: Food and Drug Administration has no authority to regulate tobacco - Food & Drug Admin. v. Brown & Williamson Tobacco Corp.

Supreme Court: Food and Drug Administration Has No Authority to Regulate Tobacco--Food & Drug Admin. v. Brown & Williamson Tobacco Corp.(1)--The Supreme Court of the United States held that Congress has not granted the Food and Drug Administration (FDA) the authority to regulate tobacco products as customarily marketed.(2)

In 1996, the FDA concluded that under The Food, Drug, and Cosmetic Act (FDCA), nicotine is a "drug" and cigarettes and smokeless tobacco are "devices" that deliver nicotine to the body. Under the FDCA, the FDA has the authority to regulate items classified as "drugs" or "devices." Pursuant to this authority, the FDA promulgated regulations governing tobacco products' promotion, labeling and accessibility to children and adolescents.(3) Respondents, a group of tobacco manufacturers, retailers and advertisers, filed suit in United States District Court for the Middle District of North Carolina challenging the FDA's 1996 assertion of jurisdiction to regulate tobacco products. …

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