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FDA v. Brown & Williamson Tobacco Corp.

Supreme Court of the United States

December 1, 1999, Argued ; March 21, 2000, Decided

No. 98-1152

Opinion

 [*125]   [***129]   [**1296]  JUSTICE O'CONNOR delivered the opinion of the Court.

 This case involves one of the most troubling public health problems facing our Nation today: the thousands of premature deaths that occur each year because of tobacco use. In 1996, the Food and Drug Administration (FDA), after having expressly disavowed any such authority since [**1297]  its inception, asserted jurisdiction to regulate tobacco products. See 61 Fed. Reg. 44619-45318. The FDA concluded that nicotine is a "drug" within the meaning of the Food, Drug, and Cosmetic Act (FDCA or Act), 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq., and that cigarettes and smokeless tobacco are "combination products" that deliver [****11]  nicotine to the body. 61 Fed. Reg. 44397 (1996). Pursuant to this authority, it promulgated regulations intended to reduce tobacco consumption among children and adolescents. Id., at 44615-44618. The agency believed that, because most tobacco consumers begin their use before reaching the age of 18, curbing tobacco use by minors could substantially reduce the prevalence of addiction in future generations and thus the incidence of tobacco-related death and disease. Id., at 44398-44399.

 Regardless of how serious the problem an administrative agency seeks to address, however, it may not exercise its authority "in a manner that is inconsistent with the administrative structure that Congress enacted into law." ETSI Pipeline Project v. Missouri, 484 U.S. 495, 517, 98 L. Ed. 2d 898, 108 S. Ct. 805 (1988). And although agencies are generally entitled to deference in the interpretation of statutes that they administer, a reviewing "court, as well as the agency, must give effect to the unambiguously  [*126]  expressed intent  [***130]  of Congress." Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-843, 81 L. Ed. 2d 694, 104 S. Ct. 2778 (1984). In this case, we believe that Congress has [****12]  clearly precluded the FDA from asserting jurisdiction to regulate tobacco products. Such authority is inconsistent with the intent that Congress has expressed in the FDCA's overall regulatory scheme and in the tobacco-specific legislation that it has enacted subsequent to the FDCA. In light of this clear intent, the FDA's assertion of jurisdiction is impermissible.

The FDCA grants the FDA, as the designee of the Secretary of Health and Human Services, the authority to regulate, among other items, "drugs" and "devices." See 21 U.S.C. §§ 321(g)-(h), 393 (1994 ed. and Supp. III). The Act defines "drug" to include "articles (other than food) intended to affect the structure or any function of the body." 21 U.S.C. § 321(g)(1)(C). It defines "device," in part, as "an instrument, apparatus, implement, machine, contrivance, . . . or other similar or related article, including any component, part, or accessory, which is . . . intended to affect the structure or any function of the body." § 321(h). The Act also grants the FDA the authority to regulate so-called "combination products," which "constitute a combination of a drug, device, or biologic [****13]  product." § 353(g)(1). The FDA has construed this provision as giving it the discretion to regulate combination products as drugs, as devices, or as both. See 61 Fed. Reg. 44400 (1996).

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529 U.S. 120 *; 120 S. Ct. 1291 **; 146 L. Ed. 2d 121 ***; 2000 U.S. LEXIS 2195 ****; 68 U.S.L.W. 4194; 2000 Cal. Daily Op. Service 2215; 2000 Daily Journal DAR 2987; 2000 Colo. J. C.A.R. 1435; 13 Fla. L. Weekly Fed. S 161

FOOD AND DRUG ADMINISTRATION, ET AL. v. BROWN & WILLIAMSON TOBACCO CORPORATION, ET AL.

Prior History:  [****1]  ON WRIT OF CERTIORARI TO THE UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT.

Disposition: 153 F.3d 155, affirmed.

CORE TERMS

tobacco, cigarettes, tobacco product, regulation, smoking, nicotine, ban, Food, effects, Hearings, advertising, products, consumers, labeling, manufacturer, addiction, smokeless, safe, public health, drugs, authority to regulate, marketed, Cosmetic, chemical, tobacco-specific, therapeutic, misbranded, illness, reasonable assurance, regulatory scheme

Governments, Legislation, Interpretation, Administrative Law, Agency Rulemaking, General Overview, Business & Corporate Compliance, Governments, Agriculture & Food, Federal Food, Drug & Cosmetic Act, Healthcare Law, Medical Treatment, Medical Devices, Premarket Approval, Antitrust & Trade Law, Consumer Protection, Deceptive Labeling & Packaging, Classification & Regulation, Tobacco Products, Federal Cigarette Labeling & Advertising Act, Product Promotions, Federal Government, Claims By & Against, Communications Law, Regulated Practices, Content Regulation, Advertising, Separation of Powers, Constitutional Controls, US Congress