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.
