FDA v. Brown & Williamson Tobacco Corp.
By: LN on May 02, 2012 10:03:17 AM

Citation:  529 U.S. 120, 120 S.Ct. 1291, 146 L.Ed.2d 121.

Summary:  Petitioner came out with a rule which regulated the sale of tobacco to young people who were less than 18 years of age. Respondents claimed that petitioner did not have authority for regulating the sale of tobacco. Petitioner claimed that he had authority under § 360j (e) of the FDCA.

Facts:  The Food and Drug Administration (FDA) published a proposed rule which concerned with the sale of cigarettes and smokeless tobacco to children and adolescents. It received 70,000 opinions as comments. Later on it issued the final rule. FDA concluded that the nicotine drug and cigarettes and smokeless tobacco were drug delivery devices and hence it had jurisdiction under the Food, Drug and Cosmetic Act (FDCA) for regulating the sale of tobacco. FDA promulgated regulations which concerned with promotion of the product, labeling and accessibility to children and adolescents. The access regulations prohibited sale of tobacco to those who were less than 18 years of age and required the retailers to sell the tobacco on photo identification to those who were younger than 27 years. Respondents a group of tobacco manufacturers, retailers and advertisers filed suit in the district court. The district court ruled in favor of petitioners holding that FDCA had given authority to FDA for regulating the sale of tobacco. Respondents filed an appeal to the appellate court which reversed the decision of the district court holding that FDA had no authority for regulating sale of tobacco. Petitioner sought review of the decision of the appellate court.

Issue:  Whether the Appellate court was correct in holding that congress had not granted jurisdiction to FDA for regulating tobacco products?

Holding:  Yes, the appellate court was correct in holding that congress had not granted jurisdiction to FDA for regulating tobacco products.

Procedure:  Judgment of the appellate court was affirmed by the United States Supreme Court.

Rule:  The Act granted FDA the authority to regulate combi-biologic product constituting a combination of a drug, device or biologic product. (Food, Drug and Cosmetic Act, § 353 (g) (1))  The agency could regulate the sale or distribution or other conditions as the FDA may regulate due to the potentiality of the harmful effect it causes or the collateral measures which are necessary for its use. There cannot be assurance for safety and effectiveness. (Food, Drug and Cosmetic Act, § 360j (e))

Rationale:  FDA had demonstrated that use of tobacco among children and adolescents posed the single most significant threat to public health in the United States. An administrative agency's power to regulate must always be derived from valid grant of authority from congress. When the Act is read as whole along with the congress's tobacco legislation it could be concluded that FDA did not have authority for rule making.

Dissent:  Four judges while dissenting opined that the holding of the court that the regulatory statute aimed at unsafe drugs and devices did not authorize regulations of a drug and a device knowing that it was unsafe. This particular drug and device risked the life threatening harms which the regulation tried to rectify.


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Michael Mordechai YadegariReviewsout of 83 reviews