{"ID":54772,"name":"Food and Drug Administration v. Brown \u0026 Williamson Tobacco Corporation","href":"https:\/\/api.oyez.org\/cases\/1999\/98-1152","view_count":0,"docket_number":"98-1152","additional_docket_numbers":null,"manner_of_jurisdiction":"Writ of \u003Ci\u003Ecertiorari\u003C\/i\u003E","first_party":"Food and Drug Administration","second_party":"Brown \u0026 Williamson Tobacco Corporation","timeline":[{"event":"Argued","dates":[944028000],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/38299"},{"event":"Decided","dates":[953618400],"href":"https:\/\/api.oyez.org\/case_timeline\/case_timeline\/38300"}],"lower_court":{"ID":9,"name":"United States Court of Appeals for the Fourth Circuit","href":"https:\/\/api.oyez.org\/taxonomy\/term\/9"},"facts_of_the_case":"\u003Cp\u003EThe Food, Drug, and Cosmetic Act (FDCA) grants the Food and Drug Administration (FDA) the authority to regulate, among other items, \u0022drugs\u0022 and \u0022devices.\u0022 In 1996, the FDA asserted jurisdiction to regulate tobacco products, concluding that, under the FDCA, nicotine is a \u0022drug\u0022 and cigarettes and smokeless tobacco are \u0022devices\u0022 that deliver nicotine to the body. Accordingly, the FDA promulgated regulations governing tobacco products\u0027 promotion, labeling, and accessibility to children and adolescents. Brown \u0026amp; Williamson Tobacco Corporation, and a group of tobacco manufacturers, retailers, and advertisers, filed suit challenging the FDA\u0027s regulations. Brown moved for summary judgement on the ground that the FDA lacked the jurisdiction to regulate tobacco products as customarily marketed, or without manufacturer claims of therapeutic benefit. The District Court ruled that the FDA had jurisdiction over tobacco as a device, but that the agency had overstepped its authority in attempting to restrict tobacco advertising. In reversing, the Court of Appeals held that Congress had not granted the FDA jurisdiction to regulate tobacco products. The court found that the FDA\u0027s definition of tobacco as a device was flawed because the agency could not prove that the impact of tobacco products on the body was \u0022intended\u0022 under the act.\u003C\/p\u003E\n","question":"\u003Cp\u003EDoes the Food and Drug Administration have the authority to regulate tobacco products as \u0022drugs\u0022 and \u0022devices\u0022 under the Food, Drug, and Cosmetic Act?\u003C\/p\u003E\n","conclusion":"\u003Cp\u003ENo. In a 5-4 opinion delivered by Justice Sandra Day O\u0027Connor, the Court held that \u0022Congress has not given the FDA the authority to regulate tobacco products as customarily marketed.\u0022 The ruling was based on the FDCA as a whole and in conjunction with Congress\u0027 subsequent tobacco-specific legislation. \u0022By no means do we question the seriousness of the problem that the FDA has sought to address,\u0022 Justice O\u0027Connor wrote for the majority. Nonetheless, Justice O\u0027 Connor wrote, \u0022Congress, for better or for worse, has created a distinct regulatory scheme for tobacco products, squarely rejected proposals to give the FDA jurisdiction over tobacco, and repeatedly acted to preclude any agency from exercising significant policymaking authority in the area.\u0022\u003C\/p\u003E\n","advocates":[{"advocate":{"ID":38892,"name":"Richard M. Cooper","href":"https:\/\/api.oyez.org\/people\/richard_m_cooper","view_count":0,"last_name":"Cooper","roles":null,"thumbnail":null,"length_of_service":0,"identifier":"richard_m_cooper"},"advocate_description":"Argued the cause for respondents","href":"https:\/\/api.oyez.org\/case_advocate\/case_advocate\/17437"},{"advocate":{"ID":42213,"name":"Seth P. 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