Supreme Court Decides Food and Drug Administration v. R.J. Reynolds Vapor Co.

On June 20, 2025, the U.S. Supreme Court decided Food and Drug Administration v. R.J. Reynolds Vapor Co., No. 23-1187, holding that retailers of an e-cigarette product, and not just the product’s manufacturer, are persons “adversely affected” by the FDA’s denial of premarket approval under the Family Smoking Prevention and Tobacco Control Act (TCA) and are entitled to seek judicial review of the FDA’s decision under the Administrative Procedure Act (APA).

The TCA requires the manufacturer of any “new tobacco product” to seek and obtain FDA approval before it may market the product. The statute provides that “any person adversely affected” by the FDA’s denial of premarket approval may petition for judicial review under the APA in either the D.C. Circuit or the circuit in which that person resides or has its principal place of business. 21 U.S.C. § 387l.

In 2016, the FDA first classified e-cigarettes as new tobacco products subject to the TCA’s premarket approval requirements. The FDA later denied R.J. Reynolds’ petition for permission to market its Vuse Alto e-cigarette products. As a North Carolina corporation, R.J. Reynolds is domiciled in the Fourth Circuit, but it joined with several retailers of the Vuse Alto products to file a petition for judicial review in the Fifth Circuit instead. The Fifth Circuit denied the FDA’s motion to dismiss the suit for improper venue, holding that the TCA’s definition of “adversely affected” persons was broad enough to include the retailers as well as the manufacturer.

The Supreme Court affirmed. It looked first to the historically broad construction of the term “adversely affected” in administrative law. The same term appears in the judicial review provision of the APA itself, and the Court has interpreted it to include any person “even arguably” within the zone of interests affected by the statute in question. The Court rejected the FDA’s argument that the APA’s wide scope is a function of its unique status as an “omnibus” judicial review statute, noting that “adversely affected” has been given a similar construction in several other statutes’ judicial review provisions. Surveying this consistent interpretive approach across statutes covering diverse subject matters, the Court inferred a “presumption that the term ‘adversely affected’ carries the same meaning outside the APA as in it.”

The Court also rejected the FDA’s argument that the structure of the TCA evinces an intent to restrict judicial review to manufacturers only. While the TCA provision governing the petition and approval process, 21 U.S.C. § 387j, is geared exclusively toward manufacturers, the Court was not persuaded that this narrower scope should be read into the judicial review provision, for two reasons. First, the statute’s description of “any” aggrieved person is inconsistent with an intent that its application be limited to a single possible entity — the manufacturer who was denied the approval. Second, the TCA authorizes judicial review of not only premarket approval decisions, but also general FDA regulations. The TCA’s text and structure, the Court reasoned, cannot be squared with the theory that only a manufacturer lies within its zone of protected interests.

Justice Barrett delivered the opinion of the Court, in which Chief Justice Roberts and Justices Thomas, Alito, Kagan, Gorsuch, and Kavanaugh joined. Justice Jackson dissented, joined by Justice Sotomayor.