After listening to arguments against the FDA’s arbitrary and capricious PMTA rejections from dozens of lawsuits, the court also heard from Eric Heyer, the lawyer for mid-sized e-liquid manufacturer Triton Distribution. He questioned what the justifications for the FDA’s decisions were, whilst referring to comparable applications by many other denied companies.
In response to these arguments, the Fifth Circuit has like the Eleventh Circuit Court of Appeals, allowed the rejected products to stay on the market at least for the duration of the lawsuit.
Like all other vape manufacturers, Triton had until September 2020 to file premarket tobacco product applications (PMTAs), ultimately having to prove its products were more likely to be used by adults looking to switch from cigarettes, as opposed to attracting teens and hooking them on nicotine.
Among the three judges who heard the Triton case, Catharina Haynes and Gregg Costa sided with the FDA, while former chief judge of the Fifth Circuit Edith Jones, disagreed with her colleagues.
Filter disclosed that Todd Wages, a partner at Triton Distribution, emphasized that they intend to keep fighting for their reduced-risk products to remain on the market. “I’m very disappointed in the court,” he said as quoted by Filter. “We’re exploring our next steps. I will not stop fighting until I can’t any longer, until every door is closed.” Heyer reiterated that the company “intends to file a petition for rehearing en banc by the entirety of the Fifth Circuit.”
Recently issued Juul MDO suspended for further reviews
This MDO appeal rejection will certainly raise significant concerns amongst vape brands who submitted similar requests. Meanwhile, the FDA has recently suspended a previously issued Juul MDO to conduct further reviews. “FDA is reviewing the marketing denial orders it issued to JUUL because in the course of reviewing litigation briefing materials the agency determined that there are scientific issues unique to this application that warrant additional review,” said an FDA spokesperson as quoted by Filter. The spokesperson added that because Juul’s “products do not have marketing authorization, [the company] cannot legally market, ship or sell their products,” and “the stay does not change this.”
“With this administrative stay from the FDA now in place, we continue to offer our products to adult smokers while we pursue the agency’s internal review process,” Joe Murillo, the chief regulatory officer at Juul Labs, said in a statement. “We remain confident in the quality and substance of our applications and believe that ultimately we will be able to demonstrate that our products do in fact meet the statutory standard of being appropriate for the protection of the public health. We now look forward to re-engaging with the FDA on a science- and evidence-based process to pursue a marketing authorization for JUUL products.”
