Case Explained: VDX Distro, Incorporated; Vapetastic, L.L.C v. United States Food & Drug Administration; Marty Makary, Commissioner, U.S. Food and Drug Administration; United States Department of Health and Human Services; Robert F. Kennedy, Jr., Secretary, U.S. Department of Health and Human Services

Court: United States Court of Appeals for the Fifth Circuit Filed: 2026-06-24 The Fifth Circuit denied the petition for review of the Food and Drug Administration’s (FDA) denial of a premarket tobacco product application for VDX Distro, Inc.’s menthol-flavored e-cigarette products. The court held that the FDA’s decision was lawful under the Family Smoking Prevention and Tobacco Control Act (TCA) and rejected all four challenges raised by the petitioners: 1. **Nondelegation/Major Questions Doctrine:** The court ruled that the petitioners’ argument, which they framed as a major questions doctrine challenge, was actually a nondelegation claim that is foreclosed by precedent (*Big Time Vapes, Inc. v. FDA*). The TCA provides an “intelligible principle” guiding the FDA’s authority to deem products as tobacco products, and Congress did not impermissibly delegate legislative power. 2. **Vagueness:** The court held that the TCA’s “appropriate for the protection of the public health” (APPH) standard is not unconstitutionally vague because it does not prohibit specific conduct or impose penalties on manufacturers; rather, it serves as an adjudicatory standard for evaluating marketing applications. 3. **Notice-and-Comment Rulemaking:** The court determined that the FDA’s “comparative-efficacy standard,” which requires non-tobacco-flavored e-cigarettes to demonstrate a benefit over tobacco-flavored ones to offset youth risks, is not a “tobacco product standard” under the TCA. Instead, it is a methodology for applying the APPH standard through adjudication. Consequently, the FDA was not required to follow notice-and-comment rulemaking procedures before adopting this standard. 4. **Arbitrary and Capricious Application:** Applying the Administrative Procedure Act’s arbitrary and capricious standard, the court found that the FDA acted reasonably in denying the application. The agency relied on relevant data regarding youth use risks and adult cessation benefits, focused on appropriate subpopulations (youth non-users and adult smokers) as permitted by the TCA, and provided a satisfactory explanation for why VDX’s proposed marketing restrictions were insufficient to mitigate youth access risks compared to biometric device barriers. As a result of this decision, the FDA’s denial of VDX Distro’s application remains in effect, and the petitioners are barred from marketing their menthol-flavored e-cigarette products without further FDA approval. Do It For The Case Law is a news reporting service. Nothing in this episode constitutes legal advice.