U.S. Fifth Circuit judges question FDA’s claim it has no de facto ban on flavored refillable e-cigarettes

Key Points

• Court and panel: U.S. Court of Appeals for the Fifth Circuit; Judges Jennifer Walker Elrod, Jerry E. Smith and Cory T. Wilson

• Core issue: whether FDA’s denial pattern for flavored refillable/open-system products functions as a de facto ban

• Key remark: Judge Wilson said near-100% denials for a product class are a de facto ban

• Procedure claim: petitioner says FDA denied applications without notice-and-comment rulemaking under the Tobacco Control Act

• Case: VDX Distro et al. Petitioners v. Food & Drug Administration et al., No. 24-60537

2Firsts, January 7, 2026 – According to Law360, a Fifth Circuit panel on Tuesday questioned the FDA’s claim that it has no de facto ban on flavored refillable e-cigarette products, suggesting that denying hundreds of thousands of applications looked like a ban.

Judge Cory T. Wilson noted that only six out of hundreds of thousands of applications to market e-cigarette products had been approved. VDX Distro Inc. appealed after the FDA denied its application to market menthol flavored e-cigarette products, arguing the agency systematically denies refillable-system applications if they lack evidence the products are more effective than tobacco-flavored products at helping adults quit smoking cigarettes.

Wilson said that if denials are effectively at 100% for a certain class of products, that is a de facto ban.

Government counsel Ben Lewis of the U.S. Department of Justice argued that approvals exist and that there is therefore no de facto ban.

Judge Jennifer Walker Elrod asked whether the FDA ever approved flavored e-cigarette products that could not show efficacy greater than tobacco-flavored products. Lewis said that if an applicant pitched the product as more effective than tobacco-flavored products at helping adults quit smoking cigarettes, the application would be denied if evidence was not provided.

VDX Distro counsel Gregory Troutman argued that the FDA violated the Family Smoking Prevention and Tobacco Control Act by not engaging in notice-and-comment rulemaking before denying applications like VDX Distro’s. He said none of the open system bottled or tank devices have been approved and called that a de facto ban on open system products.

Christian Vergonis of Jones Day, for amicus R.J. Reynolds Vapor Co., argued the FDA applied the efficacy standard to vaping products but not to other products like nicotine pouches, and said the agency would still deny applications even if menthol vaping products had equal efficacy.

The case is VDX Distro et al. Petitioners v. Food & Drug Administration et al., No. 24-60537, in the U.S. Court of Appeals for the Fifth Circuit.

Image source: Law360