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A panel of the Fifth Circuit Court of Appeals expressed skepticism Tuesday over the U.S. Food and Drug Administration’s assertion that it has not effectively banned flavored refillable e-cigarette products, suggesting that the agency’s near-total rejection rate may amount to a ban in practice.

During oral arguments, U.S. Circuit Judge Cory T. Wilson noted that the FDA has approved only six applications out of hundreds of thousands submitted by manufacturers seeking authorization to sell electronic nicotine delivery systems.

“If you’re effectively at 100% denial on a certain class of products, then it is a de facto ban,” Judge Wilson said.

The case was brought by VDX Distro Inc., which challenged the FDA’s refusal to authorize its menthol-flavored refillable e-cigarette products. The company argues that the agency has adopted an unwritten policy of rejecting refillable systems unless manufacturers prove the products are more effective than tobacco-flavored versions at helping adults quit smoking traditional cigarettes.

FDA Pushes Back on ‘De Facto Ban’ Claim

Representing the government, Justice Department attorney Ben Lewis told the court that no ban exists, emphasizing that some applications have been approved.

“There have been approvals,” Lewis said, arguing that the absence of blanket approval does not amount to a prohibition.

U.S. Circuit Judge Jennifer Walker Elrod pressed the government on whether the FDA had ever approved a flavored e-cigarette product that did not demonstrate greater cessation benefits than tobacco-flavored products. Lewis responded that applications making such claims are denied if they fail to provide supporting evidence.

Counsel for VDX Distro, Gregory Troutman, argued that the FDA violated the Family Smoking Prevention and Tobacco Control Act by effectively imposing new requirements without first engaging in notice-and-comment rulemaking.

“None of the open-system bottled or tank devices have been approved,” Troutman said. “So it is a de facto ban on open system products.”

An attorney representing industry amici echoed that concern. Christian Vergonis, speaking on behalf of R.J. Reynolds Vapor Co., argued that the FDA applies stricter standards to vaping products than to other nicotine delivery products, such as nicotine pouches.

He said the agency denies flavored vape applications even when they show similar effectiveness to tobacco-flavored products.

The panel hearing the case included Judges Jennifer Walker Elrod, Jerry E. Smith and Cory T. Wilson. The court did not issue a ruling from the bench.

The case is VDX Distro et al. v. Food & Drug Administration et al., case number 24-60537, in the U.S. Court of Appeals for the Fifth Circuit.