On July 18, the Fifth Circuit Court of Appeals denied Triton’s petition to review a marketing denial order (MDO) issued by the Food and Drug Administration (FDA) in September 2021. The decision, which industry observers have been watching for nearly a year, could cap off one of the most significant legal battles between a notable vapor manufacturer and the FDA—one that has been viewed as something of a proxy for a wider struggle. Dozens of other smaller vape companies have accused the agency of operating unfairly, and will likely be disheartened by this ruling.
Like all other vapor manufacturers, Triton had until September 2020 to file premarket tobacco product applications (PMTAs), which had to prove that their products would be “appropriate for the protection of public health.” It’s an intuitive threshold in theory: Triton had to show, in other words, that its vaping products were more likely to be used by adults looking to switch from cigarettes or stay on a safer alternative, as opposed to attracting a new generation to nicotine.
The FDA denied Triton’s PMTAs in September 2021, and the company immediately launched an appeal through the courts.
Among the three judges who heard the Triton case, Catharina Haynes and Gregg Costa sided with the FDA. Edith Jones, the former chief judge of the Fifth Circuit who has served since the Reagan administration, dissented from her colleagues.
“I will not stop fighting until I can’t any longer, until every door is closed.”
The ruling means that as things stand, Triton will not be able to sell its reduced-risk nicotine products.
“I’m very disappointed in the court,” Todd Wages, a partner at Triton Distribution, told Filter. “We’re exploring our next steps. I will not stop fighting until I can’t any longer, until every door is closed.”
Eric Heyer, the lawyer representing Triton Distribution, told Filter that the company “intends to file a petition for rehearing en banc by the entirety of the Fifth Circuit.” The move, which essentially asks the full stable of judges to weigh in on the case and potentially overturn it, amounts to something of a Hail Mary. (Appeals courts have to grant en banc hearings, and they occur only rarely.)
Heyer had put forth two arguments on behalf of the company: Firstly, that the agency “lacks authority … to impose a requirement that Triton demonstrate its flavored ENDS products are more effective at promoting smoking cessation than its tobacco flavored ENDS products”; and, secondly, that the FDA acted “arbitrarily” and “capriciously,” never making it clear that certain scientific studies would be required, and then rejecting Triton’s PMTA on the basis that it did not include those studies—all the while ignoring other relevant information, like the company’s marketing plans.
Judges Haynes and Costa, who held the majority opinion, called the first argument “blatantly wrong,” asserting that the Family Smoking Prevention and Tobacco Control Act (TCA), which gave the agency the power to regulate tobacco products in 2009, “authorizes FDA to consider comparative cessation evidence, if not expressly then impliedly.” Although acknowledging that their “job here is quite limited,” and that they “are not tasked with determining whether [they] agree with FDA’s decision,” Haynes and Costa broadly concluded that they owed the FDA deference when it came to scientific matters in which Triton and the agency fundamentally disagreed.
In an industry that’s fresh to ongoing regulation, when surprises are common and everything typically takes way longer than expected, the split decision in favor of the FDA still came as a shock to many in tobacco control. Especially considering that at the end of October 2021, different judges in the same appeals court granted Triton a stay while the company’s petition remained active. Those judges wrote in a scathing opinion that the FDA had “simply ignored Triton’s marketing plan” and “pull[ed] a surprise switcheroo” by demanding long-term studies that companies did not anticipate.
“Kafka would have understood the FDA all too well.”
The “surprise switcheroo” has been perhaps the best evidence, and the biggest criticism, that Triton and others have had. Many vape companies have long contended that the FDA never made clear that specific, extensive studies—randomized control trials and longitudinal cohort studies—would be required in an application. It was only later, they argue, facing a pile of millions of PMTAs, that the agency adopted a “Fatal Flaw” check-list style method that denied marketing applications based on whether or not those studies were included, probably to cut through a bevy of paperwork it did not anticipate.
Jones, the judge who dissented, agreed with this logic. She called the agency’s actions “a mockery of ‘reasoned administrative decision-making,” adding that “Kafka would have understood the FDA all too well.” The agency, Jones wrote, “(1) changed the rules for private entities in the middle of their marketing application process, (2) failed to notify the public of the changes in time for compliance, and then (3) rubber-stamped the denial of their applications because of the hitherto unknown requirements.”
“The majority’s analysis of these MDOs looks almost exclusively at the bottom-line result of FDA’s decisions and finds nothing to criticize,” Jones wrote. “But the facts recited above speak for themselves. FDA refused to review petitioners’ marketing restrictions, which it had repeatedly stated were key to discouraging youthful use of the products and were thus critical components of the PMTAs. FDA repeatedly counselled applications that long term studies were likely unnecessary and it said nothing about comparative efficacy studies—until the PMTA deadline was long gone; and then it refused the petitioners the opportunity to conduct such studies.”
“Finally, FDA’s defense against petitioners on the merits of their applications is loaded with post hoc rationalizations,” she continued. “Any of these errors is a ‘fatal flaw.’ Taken together, they are mortal wounds.”
Photograph by Walknboston via Flickr/Creative Commons 2.0
Show Comments