FDA v. Brown & Williamson Tobacco Corp.

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FDA v. Brown & Williamson Tobacco Corp.
Seal of the United States Supreme Court
Argued December 1, 1999
Decided March 21, 2000
Full case nameFood and Drug Administration, et al. v. Brown & Williamson Tobacco Corp., et al.
Citations529 U.S. 120 (more)
120 S. Ct. 1291; 146 L. Ed. 2d 121
Court membership
Chief Justice
William Rehnquist
Associate Justices
John P. Stevens · Sandra Day O'Connor
Antonin Scalia · Anthony Kennedy
David Souter · Clarence Thomas
Ruth Bader Ginsburg · Stephen Breyer
Case opinions
MajorityO'Connor, joined by Rehnquist, Scalia, Kennedy, Thomas
DissentBreyer, joined by Stevens, Souter, Ginsburg

FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), is an important United States Supreme Court case in the development of American administrative law. It ruled that the Food, Drug, and Cosmetic Act did not give the Food and Drug Administration (FDA) the authority to regulate tobacco products as "drugs" or "devices".

Legal principle[edit]

The scope of authority held by an agency is determined by the agency's organic statute. Where Congress repeatedly denies an agency the power to regulate a particular area, and develops a comprehensive regulatory scheme outside the control of the agency, the agency may not regulate that area.

Note: The approach in this case balances the approach of US v. Southwestern Cable Co.. Whereas Southwestern Cable allowed an agency to regulate areas not explicitly contemplated by the statute when necessary to fulfill its ultimate goal even when legislative efforts to gain such power failed, FDA does not allow agencies to regulate areas for which Congress has developed a separate statutory scheme.

Facts and procedural posture[edit]

The Food and Drug Administration (FDA) attempted to regulate tobacco products. Tobacco companies challenged the regulations. The District Court granted in part and denied in part the plaintiff's claim. The Circuit Court reversed, ruling for the tobacco company.

The Supreme Court ultimately affirmed the Circuit Court's ruling for the tobacco company, ruling that the FDA did not have the power to enact and enforce the regulations in question.


The FDA's authority to regulate came from the Food, Drug, and Cosmetic Act (FDCA). The FDA argued that nicotine was a "drug" and cigarettes and smokeless tobacco are "devices" that deliver nicotine to the body within the meaning of the FDCA. Congress had enacted a number of tobacco-specific laws after the FDCA, and the FDA had never exercised any control over tobacco. The Court concluded in light of this that Congress did not intend to give the FDA the power to regulate tobacco, and that the regulations were therefore invalid.

Further developments[edit]

This decision was overridden by the passage of the Family Smoking Prevention and Tobacco Control Act of 2009, which gave the FDA the authority to regulate the tobacco industry and control the level of nicotine in cigarettes.[1]

See also[edit]


  1. ^ Donny, Eric C.; Denlinger, Rachel L.; Tidey, Jennifer W.; Koopmeiners, Joseph S.; Benowitz, Neal L.; Vandrey, Ryan G.; Al'Absi, Mustafa; Carmella, Steven G.; Cinciripini, Paul M.; Dermody, Sarah S.; Drobes, David J.; Hecht, Stephen S.; Jensen, Joni; Lane, Tonya; Le, Chap T.; McClernon, F. Joseph; Montoya, Ivan D.; Murphy, Sharon E.; Robinson, Jason D.; Stitzer, Maxine L.; Strasser, Andrew A.; Tindle, Hilary; Hatsukami, Dorothy K. (2015). "Randomized Trial of Reduced-Nicotine Standards for Cigarettes". New England Journal of Medicine. 373 (14): 1340–9. doi:10.1056/NEJMsa1502403. PMC 4642683. PMID 26422724.

Further reading[edit]

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