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Administrative Law Keyed to Lawson
Food and Drug Administration v. Brown & Williamson Tobacco Corp.
Citation:
529 U.S. 120, 120 S.Ct. 1291, 146 L.Ed.2d 121 (2000)Facts
In 1996, the FDA asserted jurisdiction over tobacco products, concluding that nicotine was a “drug” and cigarettes were “devices” under the FDCA. The FDA determined that tobacco products were subject to regulation because nicotine affected the structure and function of the body and was intended by manufacturers to do so. The agency issued regulations aimed at reducing tobacco use among children and adolescents. Brown & Williamson and other tobacco companies challenged the FDA’s authority, arguing that Congress had never intended to give the FDA jurisdiction over tobacco products and had established a separate regulatory scheme for tobacco through other legislation. They pointed to the FDA’s own prior statements disclaiming authority over tobacco and to Congress’s repeated actions addressing tobacco regulation without granting the FDA explicit authority in this area.
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