FOOD AND DRUG ADMINISTRATION ET AL. v. BROWN & WILLIAMSON TOBACCO CORPORATION ET AL. UNITED STATES SUPREME COURT
FACTS: Before 1995, the FDA consistently stated that it did not have the power to regulate tobacco. However, in 1995, the FDA established that nicotine is a drug, and cigarettes and smokeless tobacco are devices for administering the drug. FFDCA grants the FDA authority to regulate drugs and devices. Consequently, in August 1996, the FDA issued a rule with restrictions on the sale, promotion, and labeling of tobacco products, directed at behaviors marketed to kids. A group of tobacco manufacturers, retailers, and advertisers fi led suit against the FDA, arguing that it did not have authority to regulate tobacco products and that the advertising restrictions were not permissible under the Constitution. The district court ruled that FFDCA authorizes the FDA to regulate tobacco products and that the labeling requirements were permitted. The Fourth Circuit Court of Appeals reversed, fi nding Congress did not give the FDA jurisdiction to regulate tobacco products. ISSUE: Does the FDA have jurisdiction to regulate tobacco products? REASONING: The majority (fi ve justices) saw a fatal contradiction in the FDA’s case. The FDA has jurisdiction to regulate products that are safe for their intended use. If the FDA has determined that nicotine and cigarettes are unsafe when used for their intended purposes, the FDA has a duty to ban those products—which has been explicitly prohibited by Congress. (Four dissenting justices believed that the FDA did have authority to regulate tobacco products because the FDA has authority to regulate articles intended to affect the structure or any function of the body.) Further, the majority looked to Congress’s tobacco-specifi c legislation. Congress explicitly prohibits federal agencies from imposing health-related labeling requirements on tobacco products. (The dissenting justices believed that the majority overlooked the very purpose of FFDCA: to protect public health. Given the purpose of the statute, the FDA should be permitted to regulate tobacco products.) DECISION AND REMEDY: The FDA does not have jurisdiction over tobacco products. The appellate court’s ruling was affi rmed. SIGNIFICANCE OF THE CASE: The obvious signifi – cance of this case is that the FDA was not allowed to protect children from tobacco advertisements, but this case is also a good example of the confl ict between the letter of the law and the purpose of the law. The majority of the justices based their ruling on the letter of the law: what Congress had previously said about the FDA’s authority to regulate tobacco products, which led the majority to one conclusion. The minority of the justices based their dissent on the purpose of the law: the FDA’s ability to protect the public’s health, which led the minority to a different conclusion.
CRITICAL THINKING
The fi rst reason the majority offers for its conclusion that the FDA does not have authority to regulate tobacco is that the regulation of tobacco does not fi t with the FDA’s scheme for evaluating drugs. Consequently, the FDA would be forced to ban tobacco. What evidence does the court offer for this reason? Are you persuaded by the evidence?
ETHICAL DECISION MAKING
Consider both the majority and dissenting opinions. Who are the primary stakeholders affected by the decision that the FDA cannot regulate tobacco?
