Case Info: FDA v. Wages and White Lion Investments, LLC | Date Decided: 4/2/25 | Case No. 23-1038

Link to Docket: Here.

Question Presented: Whether the court of appeals erred in setting aside FDA's denial orders as arbitrary and capricious.

Holding: The Fifth Circuit’s conclusion that the FDA acted arbitrarily and capriciously in its adjudication of manufacturers’ premarket tobacco product applications is vacated because the FDA’s denial orders were sufficiently consistent with its predecisional guidance—as to scientific evidence, comparative efficacy, and device type—and thus did not run afoul of the change-in-position doctrine.

Result: Vacated and remanded.

Voting Breakdown: Justice Alito delivered the opinion for a unanimous Court. Justice Sotomayor filed a concurring opinion.

Link to Opinion: Here.

Oral Advocates:

• For petitioner: Curtis E. Gannon, Deputy Solicitor General, Department of Justice, Washington, D.C.
• For respondents: Eric N. Heyer, Washington, D.C.

Website Link to Oral Argument: Here.

Apple Podcast Link to Oral Argument: Here.