By Timothy S. Donahue
Top Takeaways:
- Judicial skepticism: Judges questioned whether FDA unlawfully adopted a key flavored-vape review standard without public notice and comment.
- PMTA fallout: The challenge stems from FDA’s denial of millions of flavored vaping product applications beginning in 2021.
- Industry stakes: A ruling against FDA could reopen challenges to flavored vape marketing denial orders.
A federal appeals court appeared skeptical Tuesday of the U.S. Food and Drug Administration’s claim that it could require flavored vape manufacturers to prove that their products offer greater switching benefits than tobacco-flavored alternatives without first going through a formal rulemaking process.
During oral arguments before the U.S. Court of Appeals for the Fifth Circuit, judges repeatedly questioned whether the FDA’s so-called “comparative efficacy standard” constituted a new rule that should have been subject to notice-and-comment procedures under the Administrative Procedure Act.
The case stems from marketing denial orders issued to Texas-based Wages and White Lion Investments Inc., and to California-based Vapetasia LLC, after the FDA rejected applications for flavored e-liquids, including products marketed under names such as “Iced Pineapple Express” and “Suicide Bunny Mother’s Milk and Cookies.”
The dispute centers on the FDA’s position that manufacturers seeking authorization for non-tobacco-flavored vaping products must demonstrate that those products are more effective than tobacco-flavored vaping products at helping adult smokers switch away from cigarettes.
FDA adopted that approach during its 2021 review of millions of premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems. Judge Edith Jones appeared particularly troubled by the agency’s actions.
“I’m not saying that vaping is a good thing,” Jones said. “But they were arbitrarily putting hundreds of thousands of small businesses out of business, and it seems to me they ought to at least have the opportunity that the APA provided.”
Jones repeatedly questioned whether the FDA had effectively created a new rule without following required procedures. “Under the test of the Fifth Circuit, if it walks like a rule and it squawks like a rule, it’s subject to notice and comment under either the APA or FDA’s good guidance,” she said.
Justice Department attorney Joshua Koppel argued that the FDA had not engaged in rulemaking but instead evaluated applications through individual adjudications. “We adjudicated a lot of applications in a similar way,” Koppel told the court, describing the approach as “good government practice.”
The judges appeared unconvinced.
Jones pointed to the agency’s repeated use of nearly identical language in denial orders across the vaping industry. “A million denials use essentially the same language,” she said.
Judge Leslie Southwick also questioned whether companies had received adequate notice of the standard before their applications were denied.
The case is a continuation of one of the most closely watched PMTA disputes in the vaping industry. In 2022, the Fifth Circuit ruled that the FDA acted arbitrarily and capriciously when it denied the companies’ applications. However, in 2025, the U.S. Supreme Court unanimously overturned that decision, finding that the FDA’s denial was not arbitrary and capricious.
Importantly for the industry, the Supreme Court declined to address the separate notice-and-comment issue now before the Fifth Circuit. That unresolved question has become the latest battleground in litigation over the FDA’s 2021 wave of marketing denial orders.
At the time, the FDA concluded that flavored vaping products posed a heightened risk of youth uptake and generally required robust evidence demonstrating benefits to adult smokers that were sufficient to outweigh those risks. Manufacturers have long argued that they were never informed in advance that comparative evidence against tobacco-flavored products would be required.
FDA maintains that the Tobacco Control Act already requires it to weigh the likelihood that products help adult smokers switch against the likelihood that they attract youth users, and that the agency simply applied that statutory standard during application reviews.
The three-judge panel, consisting of Judges Edith Jones, Leslie Southwick, and Catharina Haynes, took the case under submission and did not indicate when a decision would be issued.
