By Timothy S. Donahue

Top Takeaways:

• Court clash: Judges question whether FDA imposed an undisclosed comparative efficacy standard
• Industry stakes: Case could reshape how flavored PMTAs are evaluated—and denied
• Regulatory tension: Core dispute centers on rulemaking vs. case-by-case adjudication

It was a simple but loaded question: can the U.S. Food and Drug Administration require vape makers to prove that flavored products help smokers switch more effectively than tobacco flavors, without ever clearly stating that such a standard exists?

That tension fueled oral arguments before the U.S. Court of Appeals for the Fifth Circuit on April 28, where seven small vaping product manufacturers are challenging the agency’s denial of applications for flavored electronic nicotine delivery systems (ENDS).

The dispute stems from marketing denial orders (MDOs) issued in 2024, including one targeting lead plaintiff NicQuid, which had submitted a premarket tobacco product application (PMTA) in 2020, supported by scientific data, consumer surveys, and youth-access controls. The FDA denied the application, concluding that the company failed to provide a “comparative efficacy study” demonstrating that its flavored products—including menthol—help adults switch from cigarettes more effectively than tobacco-flavored alternatives.

Attorney Eric P. Gotting, representing NicQuid (NicQuid et al. v. FDA), argued that the requirement was never properly disclosed and constitutes an unlawful product standard imposed without rulemaking. “We still have that with regard to non-menthol flavor products, and that has resulted in an effect of ban,” Gotting said, citing the Fifth Circuit’s earlier decision in Wages and White Lion Investments v. FDA. “Even for menthol, it’s the same rationale.”

He said the agency’s review process has effectively become a binary screening mechanism rather than an individualized scientific assessment. “All it has done is opened up this mass of applications and asked if there a comparative efficacy study,” Gotting said. “If the answer is no, you get an MDO. That is it.”

Gotting also argued that the FDA ignored its own National Youth Tobacco Survey data, which he said showed virtually no use of his clients’ specific products among middle- and high-school students.

The broader industry challenge was reinforced by amicus counsel Christian G. Vergonis, arguing for R.J. Reynolds Vapor Company, who cited internal FDA documents as evidence of a top-down policy shift rather than a product-specific review. “The titles of those memos are not application-specific,” Vergonis said. “They talk about resolving foundational questions, all based on general considerations, not specific to any one applicant.”

Vergonis argued that the approach crosses into rulemaking, which would require formal notice-and-comment procedures. “Nobody knew anything about these comparative efficacy standards before the deadline” for PMTAs in September 2020, he added.

The government pushed back, defending the FDA’s actions as consistent with statutory requirements under the Tobacco Control Act. Government attorney Kevin B. Soter said Congress placed the burden on manufacturers to demonstrate that each product is “appropriate for the protection of the public health,” requiring a population-level analysis of risks and benefits.

He emphasized the agency’s core findings: non-tobacco flavors increase youth appeal and initiation risk; marketing restrictions do not fully mitigate that risk; and available evidence does not show that flavored products provide additional cessation benefits over tobacco-flavored alternatives.

“The flavored e-cigarettes and the tobacco-flavored e-cigarettes in general have the same potential benefits to adults,” Soter said. “But the flavors are adding risk to kids.”

Soter also underscored that product-specific evidence is essential, noting that recently authorized menthol products from JUUL and NJOY succeeded because those manufacturers submitted robust data for their respective formulations. Other applicants, he said, cannot rely on those authorizations.

Members of the panel pressed both sides on these points. Judge Andrew S. Oldham questioned whether the FDA’s framework effectively forecloses approval pathways for most manufacturers. “Why doesn’t every menthol ENDS manufacturer file a one-page application that says ‘we rely on [the JUUL and NJOY authorizations]?’” Oldham asked.

Gotting responded that although prior authorizations may provide some support, the FDA still requires full statutory review, rendering such reliance insufficient.

Judge Stephen A. Higginson raised a procedural issue, asking whether the panel should wait for the court’s en banc decision on remand in the Wages case before ruling here. Gotting urged the panel to proceed, while Soter deferred to the court’s discretion. Judge Jerry E. Smith also served on the panel.

The case also addressed a narrower statutory issue involving NicQuid’s zero-nicotine products. Gotting argued that the FDA applied the same rationale for denial even though the statutory definition of a tobacco product requires nicotine, raising additional questions about the agency’s interpretation of its authority.

A decision from the Fifth Circuit could have broad implications for the nicotine industry, particularly in clarifying how the FDA evaluates flavored products and whether it can impose de facto standards without formal rulemaking. At the same time, the case underscores a persistent tension in the regulatory framework—between an agency seeking to address youth risk and manufacturers who argue that shifting expectations have made compliance unpredictable.

The outcome will likely shape not only the fate of the seven companies involved but also the broader pathway for thousands of pending PMTA applications and the future contours of FDA oversight in the vaping category.