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Food and Drug Administration v. Wages and White Lion Investments, L.L.C., dba Triton Distribution, et al.

Paid petition · United States Court of Appeals for the Fifth Circuit, No. 21-60766, 21-60800 · judgment January 3, 2024


Decided · April 2, 2025
Pre-decision estimate: 75% cert probability (95% interval 65%–83%)

Before the decision, about 18.2× the 4.1% base rate. The model weighted this up for a federal-government petitioner, counsel who has won certiorari before, and a Fifth Circuit decision below, and down for a business respondent.

Question presented

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. The question presented is: Whether the court of appeals erred in setting aside FDA's denial orders as arbitrary and capricious.

Counsel of record

For petitioner
Sarah M. Harris
Acting Solicitor General

For respondent
Eric N. Heyer
Thompson Hine LLP

Case

Conference history
Distributed for 2 conferences

Amicus briefs
3 cert-stage · 14 merits
(4 supporting pet./neither, 10 respondent)

Argument & decision

Argued December 2, 2024 — Curtis E. Gannon · Eric N. Heyer. Audio and transcript

Decided April 2, 2025. Opinion by Alito.

Proceedings

  1. May 05 2025
    Judgment Issued.
  2. Apr 02 2025
    Judgment VACATED and case REMANDED. Alito, J., delivered the opinion for a unanimous Court. Sotomayor, J., filed a concurring opinion.
  3. Dec 02 2024
    Argued. For petitioner: Curtis E. Gannon, Deputy Solicitor General, Department of Justice, Washington, D. C. For respondents: Eric N. Heyer, Washington, D. C.
  4. Nov 06 2024
    Record received from the United States Court of Appeals for the Fifth Circuit. The record is electronic and is available on PACER.
  5. Nov 06 2024
    Reply of petitioner Food and Drug Administration filed. (Distributed)
  6. Oct 22 2024
    CIRCULATED
  7. Oct 21 2024
    Record requested from the United States Court of Appeals for the Fifth Circuit.
  8. Oct 18 2024
    SET FOR ARGUMENT on Monday, December 2, 2024.
  9. Oct 15 2024
    Brief amicus curiae of Coalition of Manufacturers of Smoking Alternatives filed.
  10. Oct 15 2024
    Brief amici curiae of Thirteen Members of Congress, et al. filed.
  11. Oct 15 2024
    Brief amicus curiae of Logic Technology Development LLC filed.
  12. Oct 15 2024
    Brief amici curiae of Electronic Nicotine Delivery System Trade Associations, et al. filed.
  13. Oct 15 2024
    Brief amicus curiae of Taxpayers Protection Alliance filed.
  14. Oct 15 2024
    Brief amici curiae of R.J. Reynolds Vapor Company, et al. filed.
  15. Oct 15 2024
    Brief amicus curiae of Vapor Technology Association filed.
  16. Oct 15 2024
    Brief amicus curiae of Goldwater Institute filed.
  17. Oct 10 2024
    Brief amicus curiae of Washington Legal Foundation filed.
  18. Oct 08 2024
    Brief amici curiae of Vaping Industry Stakeholders filed.
  19. Oct 07 2024
    Brief of respondents Wages and White Lion Investments, L.L.C., dba Triton Distribution, et al. filed.
  20. Sep 03 2024
    Brief amicus curiae of Global Action to End Smoking, Inc. in support of neither party filed.
  21. Sep 03 2024
    Brief amici curiae of Sixteen Members of Congress filed.
  22. Sep 03 2024
    Brief amici curiae of Massachusetts, et al. filed.
  23. Aug 30 2024
    Brief amici curiae of Public Health, Medical, and Community Groups filed.
  24. Aug 26 2024
    Brief of petitioner Food and Drug Administration filed.
  25. Aug 26 2024
    Joint appendix filed. (Statement of cost filed)
  26. Jul 24 2024
    Motion to extend the time to file the briefs on the merits granted. The time to file the joint appendix and petitioner's brief on the merits is extended to and including August 26, 2024. The time to file respondents' brief on the merits is extended to and including October 7, 2024.
  27. Jul 23 2024
    Motion for an extension of time to file the briefs on the merits filed.
  28. Jul 02 2024
    Petition GRANTED.
  29. Jun 28 2024
    DISTRIBUTED for Conference of 7/1/2024.
  30. Jun 04 2024
    DISTRIBUTED for Conference of 6/20/2024.
  31. Jun 04 2024
    Reply of petitioner Food and Drug Administration filed. (Distributed)
  32. May 17 2024
    Brief of respondents Wages and White Lion Investments, L.L.C., dba Triton Distribution, et al. in opposition filed.
  33. May 15 2024
    Brief amici curiae of Vaping Industry Stakeholders filed.
  34. Apr 18 2024
    Brief amici curiae of Public Health, Medical, and Community Groups filed.
  35. Apr 18 2024
    Brief amicus curiae of Logic Technology Development LLC filed.
  36. Apr 05 2024
    Motion to extend the time to file a response is granted and the time is extended to and including May 17, 2024.
  37. Apr 04 2024
    Motion to extend the time to file a response from April 18, 2024 to May 17, 2024, submitted to The Clerk.
  38. Mar 19 2024
    Petition for a writ of certiorari filed. (Response due April 18, 2024)