On January 19, the Fifth Circuit Court of Appeals ordered that the cases of Triton and Vapetasia, two US-based vapor companies that filed petitions for review against the Food and Drug Administration (FDA), be reheard en banc. The move negates a previous 2-1 decision that sided with the agency. The FDA had previously issued marketing denial orders (MDOs) to Triton, a manufacturer of a variety of vaping products, and Vapetasia, an e-liquid brand.
En banc rehearings, which require a stable of judges to weigh in on a case, are rare; in the Fifth Circuit, fewer than 1 percent of cases are reheard in this way. In the end, 16 judges voted on whether to rehear Triton and Vapetasia’s case—meaning at least nine of them must have voted in favor.
The case is seen as central to tobacco harm reduction advocates’ hope that flavored vapes—which most adults switching from cigarettes find preferable or even critical, but none of which the FDA has authorized—will remain available. Many urge, too, that the market not be restricted to just the handful of large companies that have so far received authorizations for tobacco-flavored products, and that open-system vapes—not at all popular with youth—be judged differently.
“We look forward to presenting our arguments on the extremely important issues.”
The new hearing will likely occur this spring, according to people familiar with the matter.
“We are pleased that the full court granted the petition for rehearing en banc and look forward to presenting our arguments on the extremely important issues presented by Triton and Vapetasia’s cases,” Eric Heyer, Triton’s lawyer, told Filter.
An FDA spokesperson told Filter that the agency “does not comment on possible, pending, or ongoing litigation.”
Like all vapor companies, Triton and Vapetasia had to file premarket tobacco product applications (PMTAs) to the FDA by September 2020 and demonstrate, ultimately, that their products would be “appropriate for the protection of public health” (APPH)—that is, more likely to be used by adults to switch from smoking than to introduce a new generation to nicotine. In September 2021, the agency denied their applications.
Then, that October, just a month after Triton received its MDO and filed a petition for review with the Fifth Circuit, the court granted the manufacturer a full stay as the case went through the judicial process. The stay order included a scathing 20-page review of the FDA, in which a three-judge panel wrote that the agency “simply ignored Triton’s [marketing] plan” and “pull[ed] a surprise switcheroo” in demanding long-term studies that companies did not anticipate.
By July 2022, following oral arguments, the court—somewhat surprisingly—denied Triton’s petition for review. Of the three judges who heard the original case, Catharina Haynes and Gregg Costa sided with the FDA, while Edith Jones, the former chief judge of the Fifth Circuit who has served since the Reagan administration, dissented.
Triton’s lawyer, Heyer, had put forth two arguments on the company’s behalf: Firstly, that the FDA lacks the authority to require Triton show its flavored vaping products are more effective at promoting smoking cessation than its tobacco-flavored ones; and, secondly, that the FDA acted “arbitrarily” and “capriciously,” failing to make clear that certain scientific studies were necessary and then rejecting the PMTAs on the basis that they were not included and overlooking other material. The latter argument has become common among vape manufacturers appealing agency denials.
With appeals courts essentially in disagreement, these cases “could begin to get some attention from the Supreme Court.”
Other cases remain active in a number of appeals courts, though most of them have fallen in the FDA’s favor; in August, however, the Eleventh Circuit Court of Appeals ruled that six companies’ PMTAs had to be reconsidered, concluding that the agency had failed to weigh their marketing plans—despite saying that was part of the assessment.
“The Fifth Circuit now breathes life back into the MDO challenges,” Azim Chowdhury, a regulatory and public policy attorney who represents a number of vapor companies, told Filter.
At the heart of these legal battles have been the credible accusations that the FDA has not provided a level playing field—moving deadlines, shifting priorities and adding requirements after PMTAs had already been filed. Growing evidence has pointed to an agency constantly shifting course—as in leadership’s overruling of agency scientists’ recommendation to authorize Logic’s menthol vaping products, which Filter recently reported.
Now, with appeals courts essentially in disagreement, these cases “could begin to get some attention from the Supreme Court,” another industry lawyer, requesting anonymity so as not to affect their company’s PMTAs, told Filter.