Supreme Court Recognizes Broad Ability Of Persons “Adversely Affected” To Sue
Case Name and Number: FDA v. R. J. Reynolds Vapor Co., No. 23-1187
Introduction: Today, the Supreme Court held that when the Food and Drug Administration (FDA) denies a manufacturer’s application to market tobacco products, a seller of those products can challenge the denial as a “person adversely affected” by it.
Background: The Family Smoking Prevention and Tobacco Control Act provides that “any person adversely affected” by the FDA’s denial of an application to market tobacco products can sue. The Act authorizes a lawsuit in the D.C. Circuit or the circuit in which the person adversely affected resides or has their principal place of business. 21 U.S.C. § 387l(a)(1). In this case, the FDA denied an application filed by R. J. Reynolds Vapor Co. (RJR Vapor) to market e-cigarette products. Rather than file a petition in the D.C. Circuit or the Fourth Circuit (where RJR Vapor is incorporated and has its principal place of business), RJR Vapor joined a Texas seller and a Mississippi-based trade association of retailers and filed a petition in the Fifth Circuit. The Fifth Circuit held that venue was proper.
Issue: Whether a retailer that wishes to sell a new tobacco product if not for the FDA’s denial order can sue to challenge the order as a “person adversely affected” by it under 21 U.S.C. § 387j(a)(1).
Court’s Holding: In an opinion authored by Justice Barrett and joined by Chief Justice Roberts and Justices Thomas, Alito, Kagan, Gorsuch, and Kavanaugh, the Supreme Court held that “any person adversely affected” encompasses sellers of tobacco products. See 21 U.S.C. § 387l(a)(1). Relying on decisions interpreting similar language, particularly from the Administrative Procedure Act, the Court explained that the phrase “any person adversely affected” covers anyone arguably within the zone of interests to be protected or regulated by the statute. The Court explained that “adversely affected” is a “term of art with a long history in federal administrative law” that should be interpreted broadly to permit judicial review of agency decisions.
Justice Jackson, joined by Justice Sotomayor, dissented. In their view, the particular statute at issue is focused on manufacturers seeking marketing approval from the FDA for new tobacco products, and so only those manufacturers are within the zone of interests protected by the statute, and only they can sue.
The Court’s decision evidences a strong presumption in favor of administrative agency review. Although the Court issued this decision in the context of the Family Smoking Prevention and Tobacco Control Act, the Court cited many other statutes with similar wording, and so the decision provides guidance about who can sue under those statutes as well.
Read the opinion here.