FDA’s “Comparative-Efficacy” Test for Non-Tobacco-Flavored E-Cigarettes Is an APPH Adjudicatory Method, Not a § 387g Tobacco Product Standard

I. Introduction

In VDX Distro v. FDA (5th Cir. June 24, 2026), petitioners VDX Distro, Incorporated (a manufacturer of nicotine e-liquids) and Vapetastic, L.L.C. (a retailer) sought review of the U.S. Food & Drug Administration’s denial of premarket authorization to market VDX’s menthol-flavored e-cigarette products. The dispute arises under the Family Smoking Prevention and Tobacco Control Act (the “TCA”), which bars marketing “new tobacco products” absent FDA authorization through a premarket tobacco product application (“PMTA”).

The central legal conflict concerned FDA’s approach to flavored e-cigarettes—particularly its view that non-tobacco flavors pose heightened youth-initiation risks and thus must demonstrate comparative adult benefits over tobacco-flavored e-cigarettes. Petitioners attacked FDA’s authority and methodology from four angles: (1) major questions/nondelegation, (2) vagueness of the TCA’s “appropriate for the protection of the public health” (“APPH”) standard, (3) whether FDA’s “comparative-efficacy standard” is an unlawfully adopted “tobacco product standard” requiring notice-and-comment rulemaking, and (4) whether the denial was arbitrary and capricious under the Administrative Procedure Act (“APA”).

II. Summary of the Opinion

The Fifth Circuit denied the petition for review and upheld FDA’s denial. The court held:

  • Petitioners’ “major questions” framing was, in substance, a nondelegation challenge foreclosed by Big Time Vapes, Inc. v. FDA.
  • The APPH standard is not susceptible to a vagueness challenge because it does not itself prohibit conduct or attach penalties; rather, the TCA’s separate prohibition on unauthorized marketing constrains conduct.
  • FDA’s “comparative-efficacy standard” is not a “tobacco product standard” under 21 U.S.C. § 387g; it is an adjudicatory methodology for applying APPH’s comparative calculus in PMTA review.
  • FDA’s denial was not arbitrary and capricious: FDA reasonably addressed youth-use data trends, permissibly focused on salient subpopulations (adult smokers vs. youth nonusers) consistent with the TCA’s “population as a whole” mandate, and adequately explained why VDX’s marketing plan did not mitigate youth-risk sufficiently.

III. Analysis

A. Precedents Cited (and How They Shaped the Decision)

1. Supreme Court guidance on the TCA and APPH comparisons

The opinion leans heavily on FDA v. Wages & White Lion Invs., LLC, 604 U.S. 542 (2024), for two propositions central to the Fifth Circuit’s holding:

  • APPH is “inherently comparative.” The Fifth Circuit quoted Wages to emphasize that APPH “calls out for various types of comparisons,” including comparisons among new products and against products already on the market. This provided the doctrinal foundation to treat FDA’s flavor-based comparisons as statutorily contemplated rather than extra-statutory innovation.
  • Agencies may develop standards by adjudication. Citing Wages (and through it SEC v. Chenery Corp., 332 U.S. 194 (1947)), the Fifth Circuit framed FDA’s comparative-efficacy approach as a permissible adjudicatory elaboration of an open-textured statutory standard—undercutting petitioners’ claim that only § 387g rulemaking can support systematic criteria.

2. Nondelegation vs. major questions: doctrinal sorting and foreclosure

Petitioners invoked the major questions doctrine, but the court recharacterized the argument as nondelegation and found it foreclosed by circuit precedent:

  • Nat'l Fed'n of Indep. Bus. v. Dep't of Lab., 595 U.S. 109 (2025) (Gorsuch, J., concurring), was used to distinguish the doctrines: major questions polices unlikely delegations; nondelegation polices intentional transfers of legislative power.
  • West Virginia v. EPA, 597 U.S. 697 (2022), supplied the “clear congressional authorization” language that defines major questions review, but the court concluded petitioners were not truly making that kind of claim.
  • FCC v. Consumers' Rsch., 606 U.S. 656 (2025), and J.W. Hampton, Jr., & Co. v. United States, 276 U.S. 394 (1928), framed the “intelligible principle” inquiry—yet the court did not re-litigate it because Big Time Vapes, Inc. v. FDA, 963 F.3d 436 (5th Cir. 2020), already upheld the TCA’s deeming delegation. The court treated Big Time Vapes as controlling (“on all fours”).

3. Vagueness doctrine: “penalty must attach to conduct”

For vagueness, the court relied on a line of cases emphasizing that vagueness concerns arise when standards regulate conduct or attach penalties:

  • Ford Motor Co. v. Tex. Dep't of Transp., 264 F.3d 493 (5th Cir. 2001), and Grayned v. City of Rockford, 408 U.S. 104 (1972), supplied the baseline “ordinary intelligence” notice principle.
  • Jones v. City of Lubbock, 727 F.2d 364 (5th Cir. 1984), and Boutilier v. INS, 387 U.S. 118 (1967), were used to draw a categorical limit: absent an effect on conduct, a standard is not susceptible to vagueness attack. The Fifth Circuit placed APPH on the “adjudicatory standard” side of that divide.

4. APA arbitrariness review and deference for scientific judgments

On arbitrary-and-capricious review, the court applied familiar APA benchmarks:

  • FCC v. Prometheus Radio Project, 592 U.S. 414 (2021), for the requirement that agency action be “reasonable and reasonably explained.”
  • Motor Vehicle Mfrs. Ass'n of the U.S. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983), and BNSF Ry. Co. v. Fed. R.R. Admin., 62 F.4th 905 (5th Cir. 2023), for the “rational connection between the facts found and the choice made.”
  • Seven Cnty. Infrastructure Coal. v. Eagle Cnty., 605 U.S. 168 (2025), quoting Baltimore Gas & Elec. Co v. Nat'l Res. Def. Council, Inc., 462 U.S. 87 (1983), for heightened deference when agencies make “scientific judgments.”
  • Massachusetts v. EPA, 549 U.S. 497 (2007), for the proposition that agencies have “broad discretion” to choose regulatory priorities—supporting FDA’s choice to maintain heightened scrutiny of non-tobacco flavors despite declining youth-use trends.

5. Sister-circuit consensus on comparative analysis for flavored products

To reinforce the legality of flavor-based comparisons under APPH, the Fifth Circuit aligned itself with other circuits:

  • Prohibition Juice Co. v. FDA, 45 F.4th 8 (D.C. Cir. 2022)
  • Magellan Tech., Inc. v. FDA, 70 F.4th 622 (2d Cir. 2023)
  • Liquid Labs LLC v. FDA, 52 F.4th 533 (3d Cir. 2022)
  • Avail Vapor, LLC v. FDA, 55 F.4th 409 (4th Cir. 2022)
  • Gripum, LLC v. FDA, 47 F.4th 553 (7th Cir. 2022)
  • Lotus Vaping Techs., LLC v. FDA, 73 F.4th 657 (9th Cir. 2023)

The practical effect is to situate the Fifth Circuit’s decision within an emerging cross-circuit stability: APPH permits FDA to demand evidence that flavored products provide cessation/switching advantages sufficient to offset youth-initiation risk.

6. Fifth Circuit procedural context and open questions

  • Shenzhen IVPS Tech. Co., Ltd. v. FDA, 148 F.4th 306 (5th Cir. 2025), was cited on venue (important in TCA petitions for review).
  • RJ. Reynolds Vapor Co. v. FDA, 65 F.4th 182 (5th Cir. 2022), appeared in a footnote distinguishing a TCA notice-and-comment argument (raised by petitioners) from an APA notice-and-comment argument (raised by amici). The court expressly left any APA notice-and-comment challenge “for another day.”

B. Legal Reasoning

1. The court’s central move: reclassifying FDA’s “comparative-efficacy standard”

The opinion’s most consequential analysis is its statutory taxonomy. Petitioners argued that because FDA uniformly applies the comparative-efficacy standard to non-tobacco-flavored e-cigarettes, it functions like a “tobacco product standard” under § 387g and therefore required notice-and-comment rulemaking. The Fifth Circuit rejected that characterization by contrasting:

  • § 387g “tobacco product standards” as “hard-and-fast lines” regulating product attributes categorically (e.g., flavor bans, numeric limits on constituents, maximum nicotine yields).
  • § 387j APPH adjudication as a case-specific balancing inquiry about whether marketing a particular product is “appropriate for the protection of the public health,” which (by statute and by Wages) entails comparative judgments.

To operationalize that distinction, the court relied on § 387g(a)(4)’s description of the “content of tobacco product standards,” the TCA’s two enumerated standards (flavor ban in cigarettes excluding tobacco/menthol; pesticide residue limit), and FDA’s own proposed § 387g rules in the Federal Register—all of which set objective categorical limits. Against that backdrop, the comparative-efficacy standard is “a balancing test, not a ban”: it does not foreclose approval of menthol products; it raises the evidentiary showing needed to satisfy APPH given FDA’s youth-risk findings.

2. APPH and “population as a whole”: permission to reason through subpopulations

Petitioners argued FDA violated the TCA by focusing “wholly” on adult smokers’ switching benefits versus youth risks. The court read the statute differently. While § 387j(c)(4) references the “population as a whole,” it explicitly directs FDA to consider:

  • the likelihood that “existing users of tobacco products will stop,” and
  • the likelihood that “those who do not use tobacco products will start.”

Those instructions, in the court’s view, affirmatively authorize FDA to examine the very subpopulations petitioners claimed were improperly emphasized—adult smokers (cessation/switching benefits) and youth/nonusers (initiation harms)—as the mechanism to estimate overall net public-health impact.

3. Arbitrary-and-capricious review: the “stale data” and marketing plan disputes

On data, the court accepted that youth e-cigarette use declined after 2019 but emphasized FDA’s reasoned explanation: FDA credited its enforcement posture for contributing to the decline, found youth use still “worryingly high,” and noted menthol remained a substantial share of youth use. Under Seven Cnty. Infrastructure Coal. v. Eagle Cnty. and Baltimore Gas & Elec. Co v. Nat'l Res. Def. Council, Inc., the court treated these as scientific and predictive judgments warranting high deference.

On the marketing plan, the court rejected the claim that FDA refused to review it “for the sake of efficiency.” The denial letter stated FDA “is now reviewing all applicant-proposed marketing restrictions,” and the record showed FDA did review VDX’s plan. Substantively, FDA explained why point-of-sale restrictions and advertising limits were insufficient when youth frequently obtain products “after the point of sale,” and identified “device access restrictions” (e.g., biometrics) as the kind of measure that could materially change the calculus—an explanation consistent with SWT Glob. Supply, Inc. v. FDA, 139 F.4th 957 (8th Cir. 2025), which the court cited approvingly.

C. Impact

1. Reinforcing FDA’s adjudicatory latitude under APPH

The decision strengthens FDA’s ability—within PMTA adjudications—to adopt and consistently apply evidentiary frameworks that operationalize APPH’s comparative nature. By holding that a uniform comparative-efficacy approach is not, for that reason alone, a § 387g “tobacco product standard,” the Fifth Circuit reduces the force of a common industry strategy: reframing stringent APPH evidentiary demands as unlawful backdoor rulemaking.

2. Clarifying what counts as a “tobacco product standard” under § 387g

The opinion gives regulated parties and reviewing courts a functional test grounded in statutory structure: § 387g standards are categorical, attribute-setting rules that can pretermit case-by-case APPH balancing; APPH methodologies remain adjudicatory so long as they do not operate as categorical bans and still allow applicants to win by meeting the evidentiary burden.

3. Limiting vagueness challenges to APPH-like licensing standards

By characterizing APPH as non-conduct-regulating and non-penal, the court makes vagueness attacks difficult for parties challenging open-textured public-interest standards used in licensing/authorization settings—at least where the enforcement “hook” is a separate, clear prohibition (here, marketing without authorization).

4. Practical consequences for flavored (including menthol) e-cigarette PMTAs

The decision validates FDA’s view that, because tobacco-flavored e-cigarettes “have not been shown to present the same risks to youth,” non-tobacco flavors must show incremental adult benefits compared to tobacco flavor to satisfy APPH. For applicants, the practical implication is that generalized cessation evidence may be insufficient; product-specific, comparative evidence tied to flavor and switching behavior is likely necessary.

IV. Complex Concepts Simplified

  • PMTA (Premarket Tobacco Product Application): The application a manufacturer must submit to obtain FDA authorization before marketing a “new tobacco product.”
  • APPH (“Appropriate for the Protection of the Public Health”): The TCA’s approval standard requiring FDA to weigh population-level risks and benefits, including whether current users will quit/switch and whether nonusers will start.
  • “Comparative-efficacy standard” (as used here): FDA’s approach that non-tobacco-flavored e-cigarettes must show greater adult switching/cessation benefit than tobacco-flavored e-cigarettes to offset higher youth-initiation risks.
  • § 387g “tobacco product standard”: A rule that sets categorical product requirements (e.g., bans certain flavors in cigarettes, sets numeric limits). Such standards require notice-and-comment rulemaking.
  • Notice-and-comment rulemaking: The process of publishing a proposed rule, taking public comments, and then finalizing a rule; the TCA expressly requires this for § 387g product standards.
  • Arbitrary and capricious review (APA): A court asks whether the agency considered relevant factors and explained its decision rationally; courts do not reweigh scientific disputes de novo.
  • Major questions vs. nondelegation: Major questions asks whether Congress clearly authorized an agency’s extraordinary assertion of power; nondelegation asks whether Congress gave away legislative power without an “intelligible principle.” The court treated petitioners’ argument as the latter.

V. Conclusion

VDX Distro v. FDA consolidates a key principle for TCA litigation: FDA’s flavor-based “comparative-efficacy” framework is a permissible adjudicatory method for applying the APPH standard, not a § 387g tobacco product standard requiring rulemaking. The Fifth Circuit also reaffirmed that APPH is insulated from vagueness attack because it does not itself prohibit conduct, and it upheld FDA’s denial under deferential APA review. The combined effect is to entrench FDA’s comparative, population-oriented PMTA decisionmaking—especially for non-tobacco-flavored products—while narrowing the procedural and constitutional avenues for challenging that approach in the Fifth Circuit.