Reported / Citable
Background
VDX Distro, Inc. manufactures nicotine-infused liquids for e-cigarettes and sells them to retailers including co-petitioner Vapetastic, LLC. Under the Family Smoking Prevention and Tobacco Control Act (TCA), e-cigarette manufacturers must obtain FDA premarket authorization before marketing their products. VDX applied for authorization for its “Four Seasons” line, which included menthol-flavored products. FDA denied the menthol portion of the application under its “comparative-efficacy standard”—a policy requiring applicants for non-tobacco-flavored e-cigarettes to demonstrate that their products provide adult smokers a measurable benefit over tobacco-flavored alternatives, because non-tobacco flavors pose heightened youth-initiation risks.
FDA grounded its denial in a finding that menthol-flavored e-cigarettes, despite earlier hopes that they might serve as a lower-risk substitute for adult menthol cigarette smokers, had not been shown in nationally representative data to be preferred over tobacco-flavored e-cigarettes for cessation or switching purposes. At the same time, approximately 27% of youth e-cigarette users in 2022 reported using menthol-flavored products. Concluding that VDX’s application lacked sufficient evidence that the adult benefit would outweigh the youth risk, FDA determined that marketing VDX’s menthol products would not be “appropriate for the protection of the public health” (APPH) as required by the TCA.
VDX and Vapetastic petitioned the Fifth Circuit for review, raising four challenges: (1) the major questions/nondelegation doctrine; (2) unconstitutional vagueness of the APPH standard; (3) that the comparative-efficacy standard is an unlawfully adopted tobacco product standard requiring notice-and-comment rulemaking; and (4) arbitrary and capricious application of the APPH standard to VDX’s application.
The Court’s Holding
The Fifth Circuit (Judge Wilson, joined by Chief Judge Elrod and Judge Smith) denied the petition on all four grounds. On the nondelegation challenge, the court held that petitioners’ argument—however styled as a “major questions” claim—was actually a nondelegation challenge squarely foreclosed by the court’s prior decision in Big Time Vapes, Inc. v. FDA, 963 F.3d 436 (5th Cir. 2020), which upheld Congress’s delegation of deeming authority to FDA. On vagueness, the court held the APPH standard is an adjudicatory benchmark, not a conduct-prohibiting rule; because it imposes no criminal or civil penalty directly on manufacturers, it is not susceptible to a due-process vagueness challenge.
On the rulemaking challenge, the court held that FDA’s comparative-efficacy standard is not a “tobacco product standard” within the meaning of the TCA. Examining the statute’s text and the examples of actual tobacco product standards—which set categorical, objective prohibitions (e.g., no non-tobacco, non-menthol flavors in cigarettes)—the court concluded that the comparative-efficacy standard is a flexible balancing methodology developed through adjudication, not a hard-and-fast ban. The Supreme Court’s decision in FDA v. Wages & White Lion Investments, 604 U.S. 542 (2024), which affirmed that agencies may develop regulatory standards through adjudication and that the APPH inquiry is “inherently comparative,” further supported that conclusion. Because the standard is not a tobacco product standard, FDA was not required to use notice-and-comment rulemaking before applying it.
On the arbitrary-and-capricious challenge, the court rejected all three sub-arguments. FDA did not rely on stale data: it acknowledged declining youth use rates but credited its own enforcement posture as a contributing cause and maintained that youth menthol use remained a material concern. FDA’s focus on adult smokers and youth non-smokers as subpopulations was consistent with the TCA’s mandate to weigh effects on “the population as a whole, including users and nonusers.” And FDA’s review of VDX’s marketing plan was substantively adequate—the agency found VDX proposed no novel access-restriction measures beyond those FDA had already found insufficient, noting that most youth e-cigarette users obtain products through social channels rather than direct purchase.
Key Takeaways
- The Fifth Circuit joins the Second, Third, Fourth, Seventh, Ninth, and D.C. Circuits in holding that FDA’s comparative-efficacy standard for non-tobacco-flavored e-cigarettes is a lawful adjudicatory methodology, not a tobacco product standard requiring notice-and-comment rulemaking.
- The TCA’s APPH standard cannot be challenged as unconstitutionally vague because it does not itself prohibit any conduct—it is an adjudicatory criterion for marketing authorization, not a penal provision.
- Congress’s delegation of “deeming” authority to FDA under the TCA satisfies the intelligible-principle test and survives nondelegation scrutiny, as settled by Big Time Vapes; relabeling the argument as a “major questions” challenge does not change the analysis.
- Menthol-flavored e-cigarette applicants face the same heightened evidentiary burden as other non-tobacco-flavored products after FDA’s internal reassessment in 2022 concluded that robust evidence of differential adult benefit over tobacco-flavored alternatives was lacking.
Why It Matters
This decision reinforces a now-uniform federal appellate consensus that FDA’s comparative-efficacy framework is a valid exercise of adjudicatory discretion under the TCA, effectively closing off the most common legal avenue that e-cigarette manufacturers have used to challenge premarket denials. For menthol-flavored product makers specifically, the ruling confirms that the 2022 policy shift—treating menthol the same as other non-tobacco flavors—will withstand judicial review absent strong, product-specific evidence of superior adult cessation benefit.
The opinion also offers a useful doctrinal clarification on the boundary between the major questions doctrine and the nondelegation doctrine, emphasizing that the two are distinct and that courts will not allow manufacturers to bootstrap a foreclosed nondelegation challenge simply by invoking major-questions rhetoric. Attorneys advising e-cigarette companies should note that the path to marketing authorization runs through FDA’s evidentiary requirements, not the courts—and that marketing-plan restrictions aimed at limiting youth access are unlikely to move the needle unless they are genuinely novel and demonstrably effective at curbing non-purchase acquisition by minors.