Supreme Court Hears Triton and FDA Arguments; Offers Few Hints

On Monday, lawyers representing the FDA and vape manufacturer Triton Distribution faced off in the Supreme Court, taking questions from the court’s nine justices. The FDA is seeking to overturn a Fifth Circuit Court of Appeals decision that found FDA marketing denial orders (MDOs) issued to Triton and Vapetasia were “arbitrary and capricious” and violated the Administrative Procedure Act (APA).

A full transcript of the proceedings is available on the Supreme Court website.

For just over an hour the opposing attorneys—Deputy Solicitor General Curtis Gannon representing the FDA, and Eric Heyer on behalf of Triton—took turns fielding questions about whether the FDA had given clear requirements to manufacturers submitting premarket tobacco applications (PMTAs), and whether the agency had moved the goalposts after the fact when it denied millions of products without the individual assessments mandated in the Tobacco Control Act, which governs the FDA’s regulatory processes.

The Tobacco Control Act says the FDA must assess whether a product is “appropriate for the protection of public health”—a vague standard that gives the agency wide latitude to interpret. Triton argued that one element of the FDA’s denials—a requirement to show that non-tobacco-flavored vape products are comparatively more effective than tobacco-flavored ones—was introduced after the fact, as was a requirement that successful applications must include evidence from certain kinds of long-term studies.

The FDA had never said those studies were the only possible acceptable evidence, argued Gannon; it had merely said they would "likely" be needed.

The FDA, said Triton, had also claimed before applications were submitted that marketing plans (which would show how the company intended to avoid youth uptake) would be an important PMTA component. But the agency never even reviewed Triton’s plans before issuing an MDO. The FDA contended that, if ignoring marketing plans was an error at all, it was “harmless error” that could be either ignored or remedied by remanding the applications back to the agency to review marketing plans only.

The study requirement and marketing plan “switcheroos,” as one Fifth Circuit judge described them, were the major topic of discussion during the arguments. Justices Clarence Thomas and Samuel Alito seemed to lean into the argument that the FDA didn’t provide “fair notice,” with Thomas calling FDA guidance “a moving target.”

But overall, the justices seemed somewhat sympathetic to the FDA’s defense that it had not changed its position on required evidence. The agency had said such studies weren’t required, said Gannon, but made clear that some strong evidence would be needed to prove products would benefit the population as a whole.

The three liberal justices—Elena Kagan, Kentanji Brown Jackson, and Sonia Sotomayor—were clearly satisfied with the FDA’s actions, and even conservative Justices Kavanaugh and Gorsuch seemed to question whether Triton had made its fair notice case.

Kavanaugh also suggested that applicants who receive MDOs can simply reapply. Triton attorney Heyer reminded him that waiting two or three more years for another FDA decision while unable to do business would mean bankruptcy for Triton and many other companies, who would no longer be protected from FDA enforcement until receiving FDA authorization.

Indeed this would be no problem for a company like Altria, which could sell cigarettes while it waits for an FDA authorization for its vaping products. But Triton doesn’t sell cigarettes. (Altria, by the way, helped write the Tobacco Control Act, which deliberately sets a high bar for approval of low-risk cigarette alternatives.)