A federal appeals court has overturned the marketing denial orders (MDOs) against Triton Distribution and Vapetasia and directed the FDA to reevaluate the businesses' marketing applications in a much-awaited ruling. The Triton and Vapetasia requests for review were granted by the en banc panel of judges by a vote of 10–6.
Ten judges of the Fifth Circuit Court of Appeals determined that the FDA acted "arbitrarily and capriciously" when it denied Triton's premarket tobacco product applications (PMTAs) in a 52-page ruling rife with irony.
Judge Andrew S. Oldham, writing for the majority, stated that the Food and Drug Administration has taken producers of flavored e-cigarette products on a fruitless quest over a number of years. Oldham then went into some detail regarding the agency's "wild goose chase" before dismissing the FDA's argument.
Judge Oldham stated that the FDA "justifies its behavior with two principal arguments." Initially, the FDA contends that the years' worth of regulatory advice it produced was not worth the paper it was printed on since it was riddled with ambiguities and never offered an assurance that a specific application would be accepted. The FDA contends, second—and perhaps most alarmingly—that its arbitrary actions can be excused as innocuous as it guarantees to reject petitioners' applications even in the event that we remand the agency to comply with the law.
"Today, we reject both propositions.”
All of the court's sitting judges participated in the unusual en banc rehearing of the case, which resulted in the ruling. (One judge sat it out after joining the court after the case was filed.) The date of the oral arguments was May 16, 2023.
A three-judge Fifth Circuit panel's 2022 verdict against Triton was overturned by the ruling. Observers, who thought the court would take the FDA to task for granting Triton a stay after a prior Fifth Circuit panel had said the company's appeal was likely to succeed, were taken aback by the 2-1 ruling. Judge Oldham criticized the FDA in the stay judgment for continuously changing the PMTA goalposts and referred to the agency's altering regulatory criteria as a "surprise switcheroo."
Vape makers won in the Eleventh Circuit, yet other circuit courts have largely sided with the FDA in MDO challenges. This suggests that the Supreme Court may soon decide to intervene and resolve the "circuit split." Many MDO appeals are still pending in different appeals courts.
Among the 13 federal appeals courts in the US, the Fifth Circuit is regarded as the most conservative. Republican presidents appointed all 10 of the justices who voted in favor of Triton, as did three of the dissenting judges. Democrats appointed the other three members who voted in favor of the FDA.
