We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product.[1] On April 2, 2025, the Supreme Court of the United States unanimously vacated and remanded the decision by the U.S. Court of Appeals for the Fifth Circuit that set aside the FDA’s denial order for premarket approval of certain e-cigarette products.[2] The Court found that the Fifth Circuit erred in holding that the FDA’s change in position regarding the application requirements was arbitrary and capricious.[3] The Court also rejected the Fifth Circuit’s refusal to apply the harmless-error rule under the Administrative Procedure Act (APA).[4]
Wages and White Lion Investments, LLC, doing business as Triton Distribution, and Vapetasia, LLC (hereinafter collectively referred to as “manufacturers”), submitted Premarket Tobacco Product Applications (PMTAs) for various dessert-, candy-, and fruit-flavored e-cigarette products, and the FDA rejected all applications.[5] In its denial order, the FDA reasoned that the manufacturers failed to provide “sufficient scientific evidence to demonstrate that the marketing of their products would be appropriate for the protection of public health.”[6] The denial order also cited the lack of evidence from “a randomized controlled trial, longitudinal cohort study, or another reliable and robust method” that show benefits of the manufacturers’ products “over an appropriate comparator tobacco-flavored product.”[7] The FDA also stated that it did not evaluate the marketing plans that the manufacturers submitted in their PMTA, even though the FDA previously indicated that it would consider such marketing plans.[8]
The Fifth Circuit sided with the manufacturers, and found that the FDA acted arbitrarily and capriciously by changing its position with regard to requirements for the type of scientific evidence, comparative-efficacy, and device type to obtain premarket approval.[9] The Fifth Circuit also rejected the FDA’s contention that any errors were harmless.[10]
In vacating the Fifth Circuit’s holdings, the Court expressed deference to the FDA’s decision-making process and acknowledged the “broad discretion” left by the Family Smoking Prevention and Tobacco Control Act (TCA) and the FDA’s own guidance in setting the requirements for a PMTA.[11] The Court concluded that there was no change in position by the FDA as to the type of evidence required because, although the agency had “commented on the strength of various types of evidence and how particular types of evidence would likely be evaluated,” it never “la[id] down any clear test.”[12] Further, while there was no evidence that the FDA offered guidance that a specific comparison with a tobacco-flavored product would be required, the Court found that “the FDA’s comparative-efficacy standard was a natural consequence” of the agency’s earlier guidance, and that the agency was acting within its discretion to establish the comparative standard when evaluating a PMTA.[13] The Court also concluded that the FDA’s apparent prioritizing of certain types of devices for enforcement did not create a “legitimate reliance” interest that other device types would not be subject to enforcement, where the manufacturers only had “a belief about how an agency is likely to exercise its enforcement discretion,” and “could not have built up decades of reliance” when “they were part of the very first wave of marketing denials under the FDA’s newly minted jurisdiction over tobacco products.”[14] Finally, the Court found that applying the harmless-error rule here may be appropriate where “an agency’s decision is supported by a plethora of factual findings, only one of which is unsound.”[15]
This decision resolves a circuit split that had been created by the Fifth Circuit’s decision. Seven other courts of appeals have already rejected challenges to FDA’s denial of PMTAs brought on grounds that the FDA acted arbitrarily and capriciously.[16] However, the Court’s opinion points out that it addresses only the specific statutory provisions under the APA for reviewing agency decisions under the arbitrary-and-capricious standard, but does not reach the question as to violation of other provisions of the APA and TCA.[17] Thus, the Court appears to have left open the possibility of further challenges to the FDA’s denial of PMTAs by flavored e-cigarette manufacturers.
Editor: Brenden S. Gingrich, Ph.D.
[1] https://www.knobbe.com/blog/flavored-e-cigarette-manufacturers-face-regulatory-challenges/
[2] See Food and Drug Administration v. Wages and White Lion Investments, L.L.C., DBA Triton Distribution, et al., 604 US ____ (2025) (“White Lion”).
[3] See Id. at pp. 20-21.
[4] See Id. at pp. 44-45.
[5] Id. at pp. 15-16.
[6] Id. at p. 16.
[7] Id. (internal quotation marks omitted).
[8] Id. at pp. 13-14, 17.
[9] Id. at pp. 17-18; see also Wages and White Lion Investments, L.L.C. v. FDA, 90 F. 4th 357, 362 (2024) (“Wages”).
[10] White Lion at p. 18; see also Wages, 90 F.4th at 390.
[11] White Lion at pp. 24-26, pp. 31-32, 37.
[12] Id. at p. 26.
[13] Id. at p. 35-37.
[14] Id. at p.p. 39-40.
[15] Id. at p. 45.
[16] Petition for a Writ of Certiorari at 13, White Lion 604 US ____ (2025) (No. 23-1038).
[17] See White Lion 604 US at p. 19.
