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 This was later superseded by the Family Smoking Prevention and Tobacco Control Act, which granted the FDA the authority to regulate such products.

This article relies largely or entirely on a single source. (October 2017)

Quick Facts FDA v. Brown & Williamson Tobacco Corp., Argued December 1, 1999 Decided March 21, 2000 ...

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Superseded by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

Close

This 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.

The 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.

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 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.

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.^[2]

• 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)