Federal regulators faced intense scrutiny Tuesday as a three-judge panel questioned whether proper procedures were followed when implementing strict marketing requirements for flavored electronic cigarette products.
The case centers on two vape manufacturers, Wages and White Lion Investments and Vapetasia, whose applications to market flavored e-liquids were denied by the Food and Drug Administration. The companies had sought approval for products with names including “Iced Pineapple Express” and “Suicide Bunny Mother’s Milk and Cookies.”
At the heart of the dispute is what the companies describe as a “comparative efficacy standard” – a requirement that manufacturers demonstrate their non-tobacco-flavored products are more effective than tobacco-flavored alternatives at helping adult smokers transition away from traditional cigarettes.
Circuit Judge Edith Jones questioned whether the agency had properly followed the Administrative Procedure Act when implementing this standard. She emphasized that while not endorsing vaping, the regulatory approach had forced “hundreds of thousands of small businesses out of business” and suggested these companies deserved the procedural protections guaranteed by federal law.
The FDA classified e-cigarettes as tobacco products in 2016, triggering requirements under the Tobacco Control Act. Products not commercially available in the United States before February 7, 2007, must receive FDA authorization by demonstrating they are “appropriate for the protection of the public health.”
This determination requires balancing two key factors: the likelihood that new products will help existing smokers quit traditional tobacco products against the risk of encouraging non-smokers, particularly youth, to begin using nicotine products.
In 2021, the FDA issued widespread denials affecting over one million flavored vape product applications. The agency concluded that non-tobacco flavors – including fruit, candy, and dessert varieties – inherently posed elevated risks of youth vaping initiation. To counter this concern, companies needed to provide specific evidence showing their flavored products outperformed tobacco-flavored alternatives in smoking cessation efforts.
Eric Heyer, representing the vape companies, argued that both the Administrative Procedure Act and the FDA’s own “good guidance practices” regulations mandated a notice and comment period before adopting the comparative efficacy standard. He characterized the FDA’s approach as abstract and disconnected from actual evidence regarding youth usage risks in individual applications.
Judge Jones appeared sympathetic to this argument, noting the standard seemed to have been “developed beforehand” rather than through case-by-case adjudication. She referenced Fifth Circuit precedent, stating that “if it walks like a rule and it squawks like a rule, it’s subject to notice and comment.”
Joshua Koppel, representing the Justice Department and FDA, countered that the agency had simply “adjudicated a lot of applications in a similar way,” which he characterized as “good government practice.” He noted that arguments about pre-developed standards relied on an internal FDA memo that had been rescinded, and that the Supreme Court had previously declined to question the FDA’s assertion that this memo played no role in denial decisions.
Jones challenged this position, pointing out that despite claims the memo wasn’t relied upon, its language appeared directly in application denial orders. She noted that “a million denials use essentially the same language” and questioned whether 99% of subsequent applications cited identical standards or comparisons.
The current case follows a 2025 Supreme Court decision that reversed an earlier Fifth Circuit ruling finding the application denials arbitrary and capricious. However, the Supreme Court explicitly avoided addressing the notice and comment issue now before the panel.
The litigation wave following the 2021 mass denials reflects broader industry concerns about regulatory transparency. Vape manufacturers argue they weren’t adequately informed that applications lacking specific comparative efficacy evidence would face automatic denial.
The three-judge panel, including Circuit Judges Leslie Southwick and Catharina Haynes alongside Jones, took the case under submission without indicating when a ruling might be issued.
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