Background
VDX Distro, Inc. manufactures nicotine liquids for e-cigarettes and sells them to retailers, including co-petitioner Vapetastic, LLC. Under the Family Smoking Prevention and Tobacco Control Act (TCA), manufacturers cannot market tobacco products—a category that has included e-cigarettes since FDA’s 2016 deeming rule—without premarket authorization. VDX submitted a premarket tobacco product application (PMTA) seeking marketing approval for its “Four Seasons” line, many of which were menthol-flavored.
FDA denied the application as to the menthol-flavored products under what the parties call the “comparative-efficacy standard”: because non-tobacco-flavored e-cigarettes pose a known and substantial risk of youth initiation that tobacco-flavored products do not, FDA requires applicants for non-tobacco-flavored products to show a benefit to adult smokers—in terms of cessation or switching away from combustible cigarettes—that is superior to tobacco-flavored alternatives. FDA concluded that VDX’s application lacked sufficient evidence of such a comparative adult benefit to outweigh the youth-use risks, and therefore that marketing the products would not be “appropriate for the protection of the public health” (APPH) under 21 U.S.C. § 387j(c)(2)(A).
VDX and Vapetastic petitioned the Fifth Circuit for review, raising four challenges: (1) that FDA’s deeming authority violated the major questions doctrine; (2) that the TCA’s APPH standard is unconstitutionally vague; (3) that the comparative-efficacy standard is an unlawful tobacco product standard adopted without notice-and-comment rulemaking; and (4) that FDA applied the APPH standard arbitrarily and capriciously in adjudicating VDX’s application.
The Court’s Holding
Writing for a panel of Chief Judge Elrod and Judges Smith and Wilson, Judge Wilson denied the petition on all four grounds. On the first claim, the court held that petitioners’ argument was not a true major questions challenge but a nondelegation challenge, which is squarely foreclosed by the Fifth Circuit’s prior decision in Big Time Vapes, Inc. v. FDA, 963 F.3d 436 (5th Cir. 2020). On vagueness, the court held that the APPH standard is an adjudicatory criterion that does not itself prohibit any conduct; because vagueness doctrine applies only where a statute’s terms constrain conduct and expose a party to penalties, the APPH standard is not susceptible to vagueness attack.
On the notice-and-comment claim, the court held that the comparative-efficacy standard is not a “tobacco product standard” within the meaning of the TCA. Tobacco product standards, as illustrated by the two standards Congress enacted and FDA’s own proposed rules, set categorical, objective limits on product attributes. The comparative-efficacy standard, by contrast, is a flexible balancing methodology applied through adjudication—a more exacting interpretation of the APPH threshold for non-tobacco-flavored products rather than a categorical ban. The court relied on the Supreme Court’s decision in FDA v. Wages & White Lion Investments, LLC, 604 U.S. 542 (2024), which confirmed that agencies may develop regulatory standards through adjudication and that the APPH standard calls for inherently comparative judgments, including flavor-based comparisons.
On arbitrary-and-capricious review, the court rejected each of petitioners’ three sub-arguments. FDA did not rely on stale data; the record showed the agency was aware of declining youth e-cigarette use since 2019 and reasonably concluded that continued enforcement was appropriate given persisting elevated youth use levels. FDA’s focus on adult smokers and youth non-users as specific subpopulations was consistent with—not contrary to—the TCA’s “population as a whole” requirement, which directs FDA to consider both existing users and those who might start. And FDA did review VDX’s marketing plan, finding that it proposed no novel or materially different youth-access restrictions from those previously considered and found insufficient, a reasoned explanation the court declined to disturb.
Key Takeaways
- FDA’s comparative-efficacy standard—requiring non-tobacco-flavored e-cigarette applicants to show a comparative adult-cessation benefit over tobacco-flavored products—is a lawful adjudicatory methodology, not a “tobacco product standard” requiring notice-and-comment rulemaking under the TCA.
- The TCA’s APPH standard is immune from vagueness challenge because it governs FDA’s adjudicatory process, not manufacturer conduct; it is the separate statutory marketing prohibition, not the APPH standard itself, that constrains what manufacturers may do.
- Arguments that frame what is substantively a nondelegation challenge as a major questions challenge will not succeed; the two doctrines are distinct, and the Fifth Circuit’s Big Time Vapes precedent forecloses nondelegation attacks on FDA’s TCA deeming authority.
- FDA’s focus on particular subpopulations—adult smokers and youth non-users—when conducting its APPH balancing analysis does not violate the TCA’s mandate to assess risks and benefits to the “population as a whole.”
Why It Matters
This decision reinforces the FDA’s authority to apply the comparative-efficacy standard across the full range of non-tobacco-flavored e-cigarette applications—including menthol—without going through notice-and-comment rulemaking. Combined with consistent rulings from the Second, Third, Fourth, Seventh, Ninth, and D.C. Circuits, it leaves e-cigarette manufacturers with virtually no viable avenue to argue that flavor-based comparative analysis exceeds FDA’s statutory authority. The practical effect is that makers of menthol-flavored products face the same demanding evidentiary burden as makers of fruit- or candy-flavored products: demonstrate a measurable cessation advantage over tobacco-flavored alternatives, or face denial.
The decision also draws a sharp doctrinal line between the major questions and nondelegation doctrines, a distinction that will matter beyond the e-cigarette context as regulated industries continue to test the boundaries of post-Chevron administrative law. Courts entertaining industry challenges to broad congressional delegations will need to route those arguments through the correct doctrinal channel—and as this opinion illustrates, mislabeling a nondelegation claim as a major questions claim will not save it from circuit precedent.