Vape Manufacturers Battle FDA in Fifth Circuit Over “Secret” Flavor Rules
Seven independent vape liquid manufacturers have taken the Food and Drug Administration (FDA) to the Fifth Circuit Court of Appeals, challenging the agency’s blanket denial of flavored vape products. This legal showdown centers on whether the FDA unlawfully imposed a strict “comparative efficacy” standard without prior public notice, effectively banning non-tobacco flavors.
During oral arguments before a three-judge panel, the central tension revolved around a cloudy regulatory question: Can the FDA force vape makers to prove their flavored e-liquids are superior to plain tobacco flavors for smoking cessation, without ever formally announcing that requirement?
The lead plaintiff, NicQuid, submitted a comprehensive Premarket Tobacco Product Application (PMTA) in 2020. The application included scientific data, consumer surveys, and strict youth-access restrictions. NicQuid argued its products met the Tobacco Control Act’s standard of being “appropriate for the protection of the public health” by offering adult smokers a less harmful alternative.
However, in May 2024, the FDA issued a Marketing Denial Order (MDO) blocking NicQuid’s sales. The agency stated the company failed to provide a “comparative efficacy study” demonstrating that its non-tobacco flavors, including menthol, were more effective at transitioning adults away from cigarettes than tobacco-flavored alternatives.
Plaintiffs Allege “Rulemaking in Disguise”
Attorney Eric P. Gotting, representing NicQuid, argued that the FDA’s comparative efficacy requirement is essentially a “tobacco product standard.” Under the Administrative Procedure Act, such a standard requires formal notice-and-comment rulemaking, which the FDA bypassed.
Gotting contended that the FDA abandoned individualized adjudications in favor of a sweeping, unwritten ban. “All it has done is opened up this mass of applications and asked if there a comparative efficacy study,” Gotting told the panel. “If the answer is no, you get an MDO. That is it.”
He further noted that the FDA ignored its own National Youth Tobacco Survey data, which showed virtually no middle or high school use of his clients’ specific products.
Amicus attorney Christian G. Vergonis, representing R.J. Reynolds Vapor Co., bolstered this claim by pointing to internal FDA “menthol memos.” Vergonis argued these memos revealed a top-down policy shift based on general considerations rather than application-specific reviews. Citing the Fifth Circuit’s 2001 Shell Offshore precedent, he argued that adopting a policy first and applying it universally constitutes rulemaking in disguise.
The Government Defends Case-by-Case Adjudication
Kevin B. Soter, arguing on behalf of the government, defended the MDOs as straightforward, case-by-case adjudications mandated by the Tobacco Control Act. He emphasized that Congress placed the burden of proof squarely on manufacturers.
Soter outlined three foundational FDA findings driving the denials:
- Non-tobacco flavors significantly increase the risk of youth appeal and initiation.
- Traditional marketing restrictions are insufficient to fully mitigate these youth risks.
- General evidence does not prove that flavored products provide additional switching benefits for adults beyond what tobacco-flavored products offer.
“The flavored e-cigarettes and the tobacco-flavored e-cigarettes in general have the same potential benefits to adults,” Soter explained. “But the flavors are adding risk to kids.”
He noted that recent menthol approvals for Juul and NJOY were granted because those specific manufacturers submitted robust, product-specific switching data, proving that individual formulations matter.
Judicial Scrutiny and Next Steps
The panel, consisting of U.S. Circuit Judges Andrew S. Oldham, Stephen A. Higginson, and Jerry E. Smith, pressed both sides on procedural nuances.
Judge Oldham questioned the timeline, noting arguments that manufacturers were unaware of the comparative efficacy standards before the September 2020 PMTA deadline. Soter countered that the statute itself provided sufficient guidance, as interpreted by the Supreme Court.
Meanwhile, Judge Higginson questioned whether the panel should delay its ruling until the en banc court decides on the remand in the related Wages and White Lion Investments, LLC v. FDA case. Gotting urged for an immediate decision.
Adding a final layer of complexity, Gotting highlighted that the FDA applied this same denial rationale to NicQuid’s zero-nicotine liquids, despite the statutory definition of a “tobacco product” explicitly requiring the presence of nicotine.
The impending ruling from the Fifth Circuit is expected to clarify the FDA’s procedural boundaries and could determine the fate of thousands of pending vape applications submitted after the 2020 deadline.
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