FDA v. Wages and White Lion Investments, L.L.C.
| FDA v. Wages and White Lion Investments, L.L.C. | |
|---|---|
 | |
| Argued December 2, 2024 Decided April 2, 2025 | |
| Full case name | Food and Drug Administration v. Wages and White Lion Investments, L.L.C., dba Triton Distribution, et al. |
| Docket no. | 23-1038 |
| Citations | 604 U.S. ____ (more) |
| Argument | Oral argument |
| Opinion announcement | Opinion announcement |
| Case history | |
| Prior | Stay pending review granted, 16 F.4th 1130 (5th Cir. 2021); petitions for review denied, 41 F.4th 427 (5th Cir. 2022); FDA denial orders set aside, 90 F.4th 357 (5th Cir. 2024) (en banc); cert. granted (July 2, 2024) |
| Holding | |
| The FDA's denial of authorization to market flavored electronic cigarettes was not arbitrary and capricious | |
| Court membership | |
| |
| Case opinions | |
| Majority | Alito, joined by unanimous |
| Concurrence | Sotomayor |
| Laws applied | |
| Administrative Procedure Act | |
FDA v. Wages and White Lion Investments, L.L.C., 604 U.S. ____ (2025), is a United States Supreme Court decision holding that the Food and Drug Administration's denial of authorization to market flavored electronic cigarette products was not arbitrary and capricious under the Administrative Procedure Act (APA).
Background
[edit]Two makers of electronic cigarette liquids, Wages and White Lion Investments (doing business as Triton Distribution) and Vapetasia, applied to the Food and Drug Administration in 2020 for authorization to market their flavors, which have names like "Suicide Bunny Mother's Milk and Cookies" and "Iced Pineapple Express".[1] The FDA denied these applications, finding no evidence that the flavors' potential benefit to adult smokers did not outweigh the risk to youth.[2]
In January 2024, an en banc panel of the Fifth Circuit voted 10–6 in favor of the companies, setting aside the denial orders. On July 2, 2024, the Supreme Court agreed to hear the FDA's appeal.[3][1][2]
Supreme Court
[edit]Recognizing that the Family Smoking Prevention and Tobacco Control Act granted broad power over tobacco products to the FDA, Associate Justice Samuel Alito wrote for a unanimous Supreme Court in reversing the Fifth Circuit's decision. Given that this act explicitly requires the FDA to assess the likelihood that tobacco marketing will reduce tobacco usage, the Supreme Court declined to fault the agency for abandoning its initial inclusion of marketing plans in the approval process.[4]
In SEC v. Chenery Corp. (1943) and Calcutt v. FDIC (2023), the Supreme Court required courts to assess discretionary regulatory decisions using the same standards originally used by that agency. Narrowing those holdings, Alito noted that the Administrative Procedure Act's prejudicial error standard should allow the Fifth Circuit to treat the disuse of marketing plans as a harmless error because the FDA already decided to reject the applications under the statutory standard.[5]
Concurrence
[edit]Associate Justice Sonia Sotomayor wrote a concurring opinion reiterating that failure of these companies to provide scientific evidence that their products would not entice underage use was dispositive, making the change-in-position doctrine irrelevant.[4]
See also
[edit]References
[edit]- ^ a b "Supreme Court to weigh FDA's refusal to approve flavored vapes". NBC News. July 2, 2024.
- ^ a b "Supreme Court to hear case involving FDA denial of flavored vape products". The Hill. July 2, 2024.
- ^ "US Supreme Court to hear fight over FDA denial of flavored vape products". Reuters. July 2, 2024.
- ^ a b Howe, Amy (April 2, 2025). "Court tosses out lower-court ruling against FDA in flavored vape dispute". SCOTUSblog. Retrieved April 6, 2025.
- ^ Food and Drug Administration v. Wages and White Lion Investments, LLC, 604 U.S. ____ (S.Ct. 2025).