By Timothy S. Donahue

Top Takeaways

• Fifth Circuit judges questioned whether FDA denials constitute a de facto ban on flavored refillable vapes.
• The court pressed the FDA on the zero authorization rate for open-system vaping products.
• The case highlights ongoing judicial scrutiny of the FDA’s PMTA framework.

A federal appeals panel on Tuesday openly questioned whether the U.S. Food and Drug Administration’s near-universal rejection of flavored refillable e-cigarette applications amounts to a de facto ban, pressing government lawyers on how a product category can survive with zero marketing authorizations.

During oral arguments before the U.S. Court of Appeals for the Fifth Circuit, Judge Cory T. Wilson noted that the FDA has authorized only six e-cigarette products among the hundreds of thousands of premarket tobacco product applications (PMTAs) submitted since the 2020 deadline.

“If denials are effectively 100 percent for a category of products, isn’t that a ban?” Wilson asked.

The case stems from an appeal by VDX Distro Inc., which challenges the FDA’s denial of its application to market menthol-flavored refillable vaping products. VDX argues that the agency has imposed an unlawful blanket policy requiring flavored products to demonstrate they are more effective than tobacco-flavored products in helping adult smokers quit—without first adopting that standard through formal rulemaking.

U.S. Department of Justice attorney Ben Lewis rejected the characterization of a ban, arguing that FDA approvals exist and that the agency evaluates each application on a case-by-case basis.

Judge Jennifer Walker Elrod pressed Lewis on whether the FDA has ever approved a flavored e-cigarette product without evidence of greater cessation benefits than tobacco-flavored products. Lewis responded that if an applicant claims superior cessation efficacy but fails to provide supporting evidence, the FDA would deny authorization.

Counsel for VDX, Gregory Troutman, argued that the FDA’s approach violates the Family Smoking Prevention and Tobacco Control Act by imposing an unwritten standard without notice-and-comment rulemaking. He told the court that no open-system bottle of e-liquid or tank-based vaping products has been authorized, calling the outcome indistinguishable from a categorical prohibition.

“This is not individualized review,” Troutman said. “This is a de facto ban on open systems.”

The panel also heard arguments from Christian Vergonis of Jones Day, appearing for amicus R.J. Reynolds Vapor Co., who said the FDA has applied an efficacy-comparison requirement to vaping products that it does not apply to other nicotine categories, including nicotine pouches. Vergonis argued that the agency would deny flavored vaping products even if they demonstrated equal rather than superior cessation performance.

The Fifth Circuit has become a key venue for challenges to FDA nicotine and tobacco regulations, particularly from vaping manufacturers. In recent years, the court has repeatedly scrutinized the agency’s premarket tobacco product application (PMTA) process and enforcement approach, often questioning whether the FDA’s standards were clearly communicated to applicants.

That posture briefly produced major wins for the vaping industry. In early 2024, an en banc Fifth Circuit panel vacated the FDA’s denials of flavored e-liquid applications, ruling that the agency had acted arbitrarily. The U.S. Supreme Court unanimously reversed that decision in 2025, holding that the FDA had acted within its statutory authority when it denied flavored products that lacked sufficient evidence of net public health benefit.

Even so, the Supreme Court later clarified that manufacturers and retailers have standing to challenge PMTA denials, a ruling that continues to channel complex regulatory disputes back into the Fifth Circuit.

Tuesday’s argument reflects that ongoing tension: while courts have affirmed the FDA’s authority to regulate flavored products, judges remain skeptical of outcomes that effectively eliminate entire product classes without explicit bans or formal rulemaking.

The case is VDX Distro et al. v. U.S. Food and Drug Administration, No. 24-60537. No ruling has been made.