The U.S. Fifth Circuit Court of Appeals, during a panel hearing of the VDX Distro case, questioned the FDA’s claim that it had not imposed a de facto ban on flavored, refillable vapes (open systems). The judges pointed out that with only 6 out of hundreds of thousands of PMTA applications approved, a near 100% rejection rate for a product category essentially constitutes a de facto ban. The government argued that approved cases still exist; it does not constitute a ban.
Key Points
- • Court and Panel: U.S. Fifth Circuit Court of Appeals.
- Core Issue: Whether the FDA’s rejection of applications for flavored, refillable vapes constitutes a de facto ban.
- Key Statement: Judges stated that a “near 100% rejection” of a product category is a de facto ban.
- Procedural Claim: VDX Distro’s lawyers argued that the FDA violated the Family Smoking Prevention and Tobacco Control Act by rejecting applications without notice and comment.
- Case Information: VDX Distro et al. v. FDA et al., Case No. 24-60537.
Panel Expresses Skepticism During Hearing
January 6, 2026 – According to Law360, a panel of the U.S. Fifth Circuit Court of Appeals expressed skepticism during a hearing regarding the U.S. Food and Drug Administration’s (FDA) claim that it had not imposed a de facto ban on flavored, refillable vape products (open systems), noting that the mass rejection of applications “looks a lot like a ban.”
Judge Highlights Near-Total Rejection Rate
U.S. Circuit Judge Cory T. Wilson noted that only 6 out of hundreds of thousands of vape product applications had been approved.
VDX Distro Challenges FDA’s Application Standards
VDX Distro Inc., which appealed after its application for a mint-flavored vape product was rejected by the FDA, argued that the FDA systematically rejects applications for refillable systems. According to the company, if an application does not provide evidence that the product is more effective than tobacco-flavored products in helping adults quit smoking, it is rejected.
Court Considers Whether Rejections Amount to a Ban
Wilson stated that if a product category is “rejected nearly 100%,” that constitutes a de facto ban. Government attorney Ben Lewis of the U.S. Department of responded that the opposing party had not claimed the existence of an injunction and that some applications had already been approved; therefore, there was no de facto injunction.
Judges Question FDA’s Effectiveness Standard
Judge Elrod inquired whether the FDA had approved flavored vape products that could not demonstrate greater effectiveness than tobacco-flavored products. Lewis stated that if an applicant positioned their product as more effective in helping adults quit smoking than tobacco-flavored products, the application would be denied without supporting evidence.
Alleged Violation of Notice-and-Comment Requirements
Gregory Troutman, attorney for VDX Distro, stated that the FDA violated the Family Smoking Prevention and Tobacco Control Act by failing to conduct a notice-and-comment rulemaking procedure before denying applications similar to VDX Distro’s.
Claims of a De Facto Ban on Open-System Products
Troutman further stated that no open-system bottled or tank devices had been approved. Which he argued constitutes a de facto ban on open-system products.
Industry Raises Concerns Over Unequal Standards
Christian Vergonis of Jones Day, attorney for R.J. Reynolds Vapor Co., stated that the FDA applied the “effectiveness” standard at issue in the trial to vaping products but not to other nicotine products such as nicotine pouches. He also claimed that even if menthol-flavored vaping products were shown to be as effective as tobacco-flavored products. The FDA would still deny the application.
