Food and Drug Administration v. Brown and Williamson Tobacco Corporation

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Supreme Court of the United States
Food and Drug Administration v. Brown and Williamson Tobacco Corporation
Reference: 529 U.S. 120 (2000)
Term: 1999
Important Dates
Argued: December 1, 1999
Decided: March 21, 2000
Outcome
United States Court of Appeals for the 4th Circuit affirmed
Majority
Sandra Day O'Connor • Antonin Scalia • William Rehnquist • Anthony Kennedy • Clarence Thomas
Dissenting
Stephen Breyer • John Paul Stevens • David Souter • Ruth Bader Ginsburg

Food and Drug Administration v. Brown and Williamson Tobacco Corporation is a case decided on March 21, 2000, by the United States Supreme Court. It involved an attempt by the Food and Drug Administration to regulate tobacco under the Food, Drug, and Cosmetic Act.[1] Several tobacco companies challenged these regulations on the grounds that the FDA did not have jurisdiction to regulate tobacco. The Supreme Court ruled 5-4 that the FDA did not have jurisdiction to regulate tobacco products, affirming the decision of the United States Court of Appeals for the 4th Circuit.[2]

HIGHLIGHTS
  • The case: The Food and Drug Administration attempted to regulate tobacco under the Food, Drug, and Cosmetic Act.
  • The issue: Did the FDA have jurisdiction to regulate tobacco, and did the Chevron doctrine require the Court to defer to the FDA's interpretation of the act?
  • The outcome: The Supreme Court ruled 5-4 that the FDA did not have jurisdiction to regulate tobacco.


    • In brief: In 1996, the FDA asserted its authority under the Food, Drug, and Cosmetic Act to regulate tobacco, and subsequently issued regulations governing tobacco's promotion, labeling, and accessibility to minors. Several tobacco companies sued the FDA to challenge these regulations, arguing that since they did not market their tobacco with claims of a therapeutic benefit, the FDA had no jurisdiction to regulate it. The District Court sided with the FDA, but the United States Court of Appeals for the 4th Circuit reversed this decision and sided with the companies. The Supreme Court ruled 5-4 that the FDA did not have jurisdiction to regulate tobacco, affirming the decision of the Court of Appeals.

    Why it matters: The decision halted the FDA's attempts to regulate tobacco. It also established new guidelines for courts exercising deference under the Chevron doctrine.

    Background

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    The Food, Drug, and Cosmetic Act gave the Food and Drug Administration power to regulate drugs and drug-related devices. Starting in 1996, the Administration labeled nicotine a drug and cigarettes a device used to deliver nicotine, and issued regulations governing their format and marketing. Several tobacco companies sued the FDA to challenge these regulations.

    The ruling in Chevron v. Natural Resources Defense Council established the standard of Chevron deference to guide courts in their review of federal agency regulations. Chevron deference provides the following guidelines for federal courts regarding agency interpretation of a statute:

    • 1. A court must determine whether Congress has made an express intent known in the statute and that this expression is unambiguous.
    • If the intention of Congress is unambiguously stated, the inquiry must end, because the courts and agencies must give effect to the unambiguously expressed intent of Congress.
    • If, however, the intention of Congress is ambiguous, or if the statute lacks express language on a specific point, then a federal court must decide whether the agency interpretation is based on a permissible construction of the statute.
    • 2. In examining the agency's reasonable construction, a court must assess whether the decision of Congress to leave an ambiguity, or fail to include express language on a specific point, was done explicitly or implicitly.
    • If the decision of Congress was explicit, then the agency’s regulations are binding on federal courts unless those regulations are arbitrary, capricious, or manifestly contrary to statute.
    • If the decision of Congress was implicit, then so long as the agency's interpretation is reasonable, a federal court cannot substitute its own statutory construction superior to the agency's construction.[3] [4]

    Since FDA v. Brown & Williamson involved the FDA's interpretation of the Food, Drug, and Cosmetic Act, the Supreme Court followed the Chevron scheme to evaluate that interpretation.

    Oral argument

    Oral argument was held on December 1, 1999. The case was decided on March 21, 2000.[2]

    Decision

    The Supreme Court ruled 5-4 that Congress had intended to exclude tobacco from the Food, Drug, and Cosmetic Act and place it under its own regulatory scheme, so the FDA did not have jurisdiction to regulate it. This affirmed the decision of the United States Court of Appeals for the 4th Circuit.

    Justice Sandra Day O'Connor wrote the majority opinion and was joined by Chief Justice William Rehnquist and Justices Antonin Scalia, Anthony Kennedy, and Clarence Thomas.

    Justice Stephen Breyer wrote a dissenting opinion and was joined by Justices John Paul Stevens, David Souter, and Ruth Bader Ginsburg.

    Opinions

    Opinion of the court

    Writing for the Court, Justice Sandra Day O'Connor used Chevron deference to evaluate the Food, Drug, and Cosmetic Act. The first step of that process required the Court to determine Congress' intent when it passed the act. O'Connor argued that since the act had given the FDA a mandate to ensure that any product it regulated was safe, and since tobacco had been proven to be unsafe, then the FDA would have been obligated to ban the sale of all tobacco products. Congress had, however, "foreclosed the removal of tobacco products from the market." She cited a provision of the United States Code that held the following:

    “ [t]he marketing of tobacco constitutes one of the greatest basic industries of the United States with ramifying activities which directly affect interstate and foreign commerce at every point, and stable conditions therein are necessary to the general welfare. 7 U. S. C. § 1311(a).[2][5] ”


    O'Connor concluded that provision, coupled with the fact that Congress had passed six statutes regulating tobacco since 1965, demonstrated a clear intent by Congress that tobacco fall under its own regulatory scheme and outside the purview of the FDA. The Court thus held that the FDA had no jurisdiction to regulate tobacco products.

    Concurring opinions

    There were no concurring opinions.

    Dissenting opinions

    Justice Stephen Breyer wrote a dissenting opinion and was joined by Justices John Paul Stevens, David Souter, and Ruth Bader Ginsburg. Breyer argued that the Court should accept the FDA's interpretation of the Food, Drug, and Cosmetic Act because it was a more convincing literal reading of the statute. He also disagreed with the majority's assertions regarding Congress' intent in passing the act and argued that the post-1965 acts passed by Congress had not deprived the FDA of jurisdiction to regulate tobacco.

    “ The upshot is that the Court today holds that a regulatory statute aimed at unsafe drugs and devices does not authorize regulation of a drug (nicotine) and a device (a cigarette) that the Court itself finds unsafe. Far more than most, this particular drug and device risks the life-threatening harms that administrative regulation seeks to rectify. The majority's conclusion is counterintuitive. And, for the reasons set forth, I believe that the law does not require it.[2][5] ”

    Impact

    The ruling halted the attempts by the FDA to regulate tobacco products.

    In her use of Chevron deference, Justice Sandra Day O'Connor argued that FDA v. Brown & Williamson merited an exception to the normal proceedings under that doctrine.

    “ Chevron deference is premised on the theory that a statute's ambiguity constitutes an implicit delegation from Congress to the agency to fill in the statutory gaps. In extraordinary cases, however, there may be reason to hesitate before concluding that Congress has intended such an implicit delegation. This is hardly an ordinary case.[2][5] ”


    In her view, if Congress had wanted to give the FDA a mandate to regulate an industry that formed such a large part of the American economy, then it would have done so in a clearer and less ambiguous manner. Thus, the Court was not bound to accept the FDA's interpretation of the Food, Drug, and Cosmetic Act in this case.

    See also

    External links

    Footnotes

    1. ↑ Legal Information Institute, 21 U.S. Code Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT, accessed December 17, 2017
    2. ↑ 2.0 2.1 2.2 2.3 2.4 Justia, FDA v. Brown & Williamson Tobacco Corp., accessed December 17, 2017
    3. ↑ U.S. Department of Justice, "Chevron, U.S.A. v. Natural Res. Def. Council," accessed July 15, 2016
    4. ↑ Supreme Court of the United States (via Findlaw), Chevron U.S.A. v. Natural Res. Def. Council, decided June 25, 1984
    5. ↑ 5.0 5.1 5.2 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
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