FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), is an important United States Supreme Court case in U.S. 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." This was later superseded by the Family Smoking Prevention and Tobacco Control Act, which granted the FDA the authority to regulate such products.
| FDA v. Brown & Williamson Tobacco Corp. | |
|---|---|
 | |
| Argued December 1, 1999 Decided March 21, 2000 | |
| Full case name | Food and Drug Administration, et al. v. Brown & Williamson Tobacco Corp., et al. |
| Citations | 529 U.S. 120 (more) 120 S. Ct. 1291; 146 L. Ed. 2d 121 |
| Holding | |
| The Food and Drug Administration has no authority to regulate tobacco products. | |
| Court membership | |
| |
| Case opinions | |
| Majority | O'Connor, joined by Rehnquist, Scalia, Kennedy, Thomas |
| Dissent | Breyer, joined by Stevens, Souter, Ginsburg |
| Laws applied | |
| Food, Drug, and Cosmetic Act | |
Superseded by | |
| Family Smoking Prevention and Tobacco Control Act | |
Legal principle
editThis section needs additional citations for verification. (September 2019) |
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 agency's control, the agency may not regulate that area.
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
editThe Food and Drug Administration (FDA) attempted to regulate tobacco products. Tobacco companies, including Brown & Williamson and Philip Morris Companies (among others), challenged the regulations.[1] 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.
Analysis
editThe 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 several tobacco-specific laws after the FDCA, and the FDA had never exercised any control over tobacco. The Court concluded that Congress did not intend to give the FDA the power to regulate tobacco and that the regulations were therefore invalid.
Further developments
editThis 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.[2]
See also
edit- Major questions doctrine – Principle of interpretation in United States law
- List of United States Supreme Court cases, volume 529
- List of United States Supreme Court cases
- Lists of United States Supreme Court cases by volume
- Y1 (tobacco)
References
edit- ^ Greenhouse, Linda (March 22, 2000). "High Court Holds F.D.A. Can't Impose Rules on Tobacco". The New York Times. ISSN 0362-4331. Retrieved May 15, 2019.
- ^ 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- Suing the Tobacco and Lead Pigment Industries: Government Litigation as Public Health Prescription by Donald G. Gifford. Ann Arbor, University of Michigan Press, 2010. ISBN 978-0-472-11714-7
External links
edit- Text of FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) is available from: CourtListener Google Scholar Justia Library of Congress Oyez (oral argument audio)