Case Info: FDA v. Wages and White Lion Investments, LLC | Case No. 23-1038 | Date Argued: 12/2/24 | Date Decided: 4/2/25

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. The agency may grant such authorization only if the applicant shows, among other things, that the marketing of the product would be "appropriate for the protection of the public health." 21 U.S.C. 387j(c)(2)(A). In this case, the agency denied respondents' applications for authorization to market new e-cigarette products because they had failed to show that marketing the products would be appropriate for the protection of the public health. The Fifth Circuit set aside FDA's denial orders as arbitrary and capricious, relying on legal theories that have been rejected by other courts of appeals that have reviewed materially similar FDA denial orders.

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 Opinion Summary: Here.

Apple Podcast Link to Opinion Summary: Here.