FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 34 (2000)

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

Opinion of the Court

requires expansion, that is the job of Congress." Action on Smoking and Health v. Harris, 655 F. 2d, at 243. In 1980, the FDA also denied a request by ASH to commence rule-making proceedings to establish the agency's jurisdiction to regulate cigarettes as devices. See Letter to ASH Executive Director Banzhaf from FDA Comm'r Goyan (Nov. 25, 1980), App. 50-51. The agency stated that "[i]nsofar as rulemaking would relate to cigarettes or attached filters as customarily marketed, we have concluded that FDA has no jurisdiction under section 201(h) of the Act [21 U. S. C. § 321(h)]." Id., at 67.

In 1983, Congress again considered legislation on the subject of smoking and health. HHS Assistant Secretary Brandt testified that, in addition to being "a major cause of cancer," smoking is a "major cause of heart disease" and other serious illnesses, and can result in "unfavorable pregnancy outcomes." 1983 House Hearings 19-20. He also stated that it was "well-established that cigarette smoking is a drug dependence, and that smoking is addictive for many people." Id., at 20. Nonetheless, Assistant Secretary Brandt maintained that "the issue of regulation of tobacco . . . is something that Congress has reserved to itself, and we do not within the Department have the authority to regulate nor are we seeking such authority." Id., at 74. He also testified before the Senate, stating that, despite the evidence of tobacco's health effects and addictiveness, the Department's view was that "Congress has assumed the responsibility of regulating . . . cigarettes." Smoking Prevention and Education Act: Hearings on S. 772 before the Senate Committee on Labor and Human Resources, 98th Cong., 1st Sess., 56 (1983) (hereinafter 1983 Senate Hearings).

Against this backdrop, Congress enacted three additional tobacco-specific statutes over the next four years that incrementally expanded its regulatory scheme for tobacco products. In 1983, Congress adopted the Alcohol and Drug Abuse Amendments, Pub. L. 98-24, 97 Stat. 175 (codified at

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