FDA v. Brown & Williamson Tobacco Corp.

FDA v. Brown & Williamson Tobacco Corp.
Supreme Court of the United States
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
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
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Superseded by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

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 This was later superseded by the Family Smoking Prevention and Tobacco Control Act, which granted the FDA the authority to regulate such products.

Decision

The Food and Drug Administration (FDA)'s authority comes from the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA). In the early 1990s, the FDA began arguing that nicotine was a "drug" and cigarettes and smokeless tobacco are "devices" that deliver it to the body. Tobacco companies, including Brown & Williamson and Philip Morris, challenged the regulations, arguing that Congress had enacted several tobacco-specific laws after the FDCA.

The District Court partially granted the companies' 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 Court concluded that Congress did not intend to give the FDA the power to regulate tobacco, making the regulations invalid.

Legal principle

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.

Whereas United States v. Southwestern Cable Co. (1968) allowed an agency to regulate outside its statutorily designated areas when necessary to fulfill its overarching goal, this decision forbids agencies from regulating in areas where Congress has developed a separate statutory scheme.

Further developments

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.

See also

• Major questions doctrine – Principle of interpretation in United States law
• Y1 (tobacco)

Further reading

• 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

• 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)