Key Takeaways
- A Fifth Circuit panel heard arguments Tuesday in a case challenging FDA marketing denial orders for flavored vape products.
- The plaintiffs said FDA required a “comparative efficacy study” showing flavored products help smokers switch better than tobacco-flavored products without previously making that standard clear.
- FDA issued a marketing denial order to NicQuid in May 2024 and denied the six other plaintiffs on similar grounds.
- The plaintiffs argued that the requirement effectively amounts to a tobacco product standard that should have gone through notice-and-comment rulemaking.
2Firsts, April 30，2026
According to the report, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit heard oral arguments on Tuesday in a case brought by seven small vape-liquid companies challenging the Food and Drug Administration’s denial of marketing authorization for flavored electronic nicotine delivery systems.
The case centers on FDA’s flavored vape denial standard
The report said lead plaintiff NicQuid filed a detailed Premarket Tobacco Product Application in 2020, including scientific data, consumer surveys and youth-access restrictions.
NicQuid argued that its products satisfied the Tobacco Control Act’s “appropriate for the protection of the public health” standard, which requires FDA to weigh risks and benefits for the population as a whole while balancing youth protection and adult smoker switching.
FDA denied NicQuid’s application in May 2024
According to the report, FDA issued a Marketing Denial Order in May 2024, blocking sales. The agency said NicQuid had failed to provide a “comparative efficacy study” showing that its non-tobacco-flavored products, including menthol, help adults switch from cigarettes better than tobacco-flavored versions.
The other six plaintiffs received similar denials, and the cases were later consolidated.
The plaintiffs said FDA’s approach violates two laws
Attorney Eric P. Gotting, representing NicQuid, told the panel that FDA’s approach violates both the Tobacco Control Act and the Administrative Procedure Act. He argued that the comparative efficacy requirement effectively amounts to a “tobacco product standard” that should have gone through formal notice-and-comment rulemaking.
The plaintiffs said FDA was not conducting real individualized review
Gotting said FDA was not actually performing individualized adjudications, but instead simply checking whether an application included a comparative efficacy study and issuing a marketing denial order if it did not. He also said FDA ignored its own National Youth Tobacco Survey data showing that virtually no middle- or high-school students were using his clients’ specific products.
Amicus counsel said internal memos showed a top-down policy shift
Christian G. Vergonis, appearing as amicus counsel for R.J. Reynolds Vapor Co., also argued that notice-and-comment procedures were required. He pointed to internal FDA menthol memos and said they reflected a top-down policy change rather than application-specific review.
FDA said manufacturers already bear the burden of proof
Government attorney Kevin B. Soter defended the denials as case-by-case adjudications required by the Tobacco Control Act. He said Congress placed the burden on manufacturers to prove that each specific new product is appropriate for the protection of public health.
FDA emphasized three central findings
Soter said FDA’s three central findings were that non-tobacco flavors significantly increase youth appeal and initiation risk, traditional marketing restrictions do not fully mitigate that risk, and general evidence does not show that flavored products provide added switching benefits for adults beyond tobacco-flavored ones.
FDA said approved products submitted product-specific switching data
Soter said six recently authorized menthol products from Juul and NJOY succeeded because those manufacturers submitted strong switching data for their specific formulations. He said other manufacturers cannot simply rely on already approved applications.
Judges questioned the logic of menthol review
The report said U.S. Circuit Judge Andrew S. Oldham questioned both sides about menthol products. He asked why every menthol ENDS manufacturer could not simply file a short application relying on the Juul and NJOY approvals. Gotting responded that existing approvals may be relevant, but FDA must still conduct a full statutory review.
The panel also discussed whether to wait for another related ruling
U.S. Circuit Judge Stephen A. Higginson asked whether the panel should wait for the en banc court’s decision on remand in the Wages case. Gotting urged the panel to rule now, while Soter left that question to the court.
NicQuid also raised an issue involving zero-nicotine products
Gotting briefly raised a separate issue involving NicQuid’s zero-nicotine liquids. He said FDA applied the same denial rationale to those products even though the statutory definition of “tobacco product” requires nicotine.
The ruling could affect thousands of pending applications
The report said the panel also included U.S. Circuit Judge Jerry E. Smith. A ruling in the case could affect thousands of pending applications and clarify how much procedural leeway FDA has in reviewing the large number of vape products submitted after the 2020 PMTA deadline.
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