FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 10 (2000)

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Cite as: 529 U. S. 120 (2000)

Opinion of the Court

manufacturer from sponsoring any athletic, musical, artistic, or other social or cultural event using its brand name. Id., at 44617-44618. The labeling regulation requires that the statement, "A Nicotine-Delivery Device for Persons 18 or Older," appear on all tobacco product packages. Id., at 44617.

The FDA promulgated these regulations pursuant to its authority to regulate "restricted devices." See 21 U. S. C. 360j(e). The FDA construed 353(g)(1) as giving it the discretion to regulate "combination products" using the Act's drug authorities, device authorities, or both, depending on "how the public health goals of the act can be best accomplished." 61 Fed. Reg. 44403 (1996). Given the greater flexibility in the FDCA for the regulation of devices, the FDA determined that "the device authorities provide the most appropriate basis for regulating cigarettes and smokeless tobacco." Id., at 44404. Under 21 U. S. C. 360j(e), the agency may "require that a device be restricted to sale, distribution, or use . . . upon such other conditions as [the FDA] may prescribe in such regulation, if, because of its potentiality for harmful effect or the collateral measures necessary to its use, [the FDA] determines that there cannot otherwise be reasonable assurance of its safety and effectiveness." The FDA reasoned that its regulations fell within the authority granted by 360j(e) because they related to the sale or distribution of tobacco products and were necessary for providing a reasonable assurance of safety. 61 Fed. Reg. 44405-44407 (1996).

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 regulations. See Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374 (1997). They moved for summary judgment on the grounds that the FDA lacked jurisdiction to regulate tobacco products as customarily marketed, the regulations exceeded the FDA's authority under 21 U. S. C. 360j(e), and the advertis-


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