Summary of Federal District Court's Ruling On the Food and Drug Administration's Jurisdiction Over, and Regulation of Cigarettes and Smokeless Tobacco

On April 25, 1997, Judge William Osteen of the Federal District Court in Greensboro, North Carolina, ruled that FDA has jurisdiction under the Federal Food, Drug, and Cosmetic Act to regulate nicotine-containing cigarettes and smokeless tobacco.¹ The Court held that "tobacco products fit within the FDCA's definitions of 'drug' and 'device,'" and that FDA can regulate cigarettes and smokeless tobacco products as drug delivery devices under the combination product and restricted device provisions of the Act.

With respect to the tobacco rule, the Court upheld all restrictions involving youth access and labeling, including two access provisions that went into effect Feb. 28: (1) the prohibition on sales of cigarettes and smokeless tobacco products to children and adolescents under 18, and (2) the requirement that retailers check photo identification of customers who are under 27 years of age. The Court also upheld additional access and labeling restrictions originally scheduled to go into effect Aug. 28, 1997, including a prohibition on self-service displays and the placement of vending machines where children have access to them. The Court also upheld the ban on distribution of free samples, the sale of so-called kiddie packs of less than 20 cigarettes, and the sale of individual cigarettes. However, the Court delayed implementation of the provisions that have not yet gone into effect pending further action by the Court.

The Court invalidated on statutory grounds FDA's restrictions on the advertising and promotion of cigarettes and smokeless tobacco. Judge Osteen found that the statutory provision relied on by FDA, section 520(e) of the Act (21 U.S.C. 360j(e)), does not provide FDA with authority to regulate the advertising and promotion of tobacco products. Specifically, the Court found that the authority in that section to set "such other conditions" on the sale, distribution, or use of a restricted device does not encompass advertising restrictions. Because Judge Osteen based his ruling on the advertising provisions on purely statutory grounds, he declined to consider the First Amendment challenge to those parts of the rule. The government is appealing the advertising portion of the ruling.

1. Coyne Beahm, et al. v. FDA, et al., United States Tobacco Company, et al. v. FDA, et al., National Association of Convenience Stores, et al. v. Kessler, et al., American Advertising Federation, et al. v. Kessler, et al. (M.D.N.C.).

BG 97-9