Case Info: FDA v. R.J. Reynolds Vapor Co. | Case No. 23-1187 | Date Argued: 1/21/25

Link to Docket: Here.

Background:

The Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, Div. A, 123 Stat. 1776, requires a person to obtain authorization from the Food and Drug Administration (FDA) before introducing a new tobacco product into interstate commerce. If FDA denies an application for authorization, "any person adversely affected by such * * * denial may file a petition for judicial review of such * * * denial with the United States Court of Appeals for the District of Columbia or for the circuit in which such person resides or has their principal place of business." 21 U.S.C. 387l(a)(l). The U.S. Court of Appeals for the Fifth Circuit has determined that a manufacturer may seek judicial review in that circuit even if it neither resides nor has its principal place of business there, so long as its petition is joined by a seller of its products, such as a gas station or convenience store, based in the circuit.

Question Presented: Whether a manufacturer may file a petition for review in a circuit (other than the D.C. Circuit) where it neither resides nor has its principal place of business, if the petition is joined by a seller of the manufacturer's products that is located within that circuit.

Holding: Retailers who would sell a new tobacco product if not for the FDA's denial order may seek judicial review of that order under § 387l(a)(1).

Result: Affirmed and remanded.

Voting Breakdown: 7-2. Justice Barrett delivered the opinion of the Court, in which Chief Justice Roberts and Justices Thomas, Alito, Kagan, Gorsuch and Kavanaugh joined. Justice Jackson filed a dissenting opinion, in which Justice Sotomayor joined.

Link to Opinion: Here.

Oral Advocates:

• For Petitioners: Vivek Suri, Assistant to the Solicitor General, Department of Justice, Washington, D.C.
• For Respondents: Ryan J. Watson, Washington, D.C.