The Fifth Circuit Court of Appeals listened to oral arguments on January 31 about a case that could help to determine the future of the US vape industry.
Eric Heyer, the lawyer for mid-sized e-liquid manufacturer Triton Distribution, argued that the Food and Drug Administration (FDA) acted “arbitrarily” and “capriciously” in denying his client’s premarket tobacco product application (PMTA). All vapor manufacturers had to file PMTAs for each individual product by September 2020 to stay legally on the market. The FDA, in turn, had until September 2021 to determine whether more than 6 million submissions were “appropriate for the protection of public health” (APPH)—a standard now understood as a product’s likelihood of helping adult smokers switch to a safer alternative rather than introducing a new generation to nicotine.
The question before the court concerns how exactly the FDA ended up denying Triton’s PMTA—with potential implications for comparable applications by many other denied companies.
So far, the FDA has authorized a single vaping product and two tobacco-flavored e-liquid cartridges, punted on the players with the largest market share and denied thousands of less well financed applications.
The question before the court concerns how exactly the FDA ended up denying Triton’s PMTA—with potential implications for comparable applications by many other denied companies.
The agency’s process, Heyer argued, set Triton up for failure: Because only after the PMTA deadline had passed did the FDA indicate that successful applications would likely need two types of long-term studies—randomized controlled trials (RCTs) and longitudinal cohort studies—to demonstrate “comparative efficacy.” In lay terms, these analyses needed to conclude that products helped smokers quit, not only that they were safer than cigarettes.
There were early signs that the court would agree with Heyer’s logic: At the end of October, the Fifth Circuit granted Triton a full stay, allowing the manufacturer to continue selling its products as the lawsuit snaked its way through the judicial system. Along with that decision, three judges—Andrew Oldham, Cory Wilson and Jennifer Elrod—issued a scathing opinion, stating that the FDA “simply ignored Triton’s [marketing] plan” and “pull[ed] a surprise switcheroo” by demanding long-term studies the companies did not anticipate.
As Filter reported, in memos made public from those court filings, the FDA appeared to resort to a “Fatal Flaw,” checklist-like process that looked for the inclusion of RCTs or longitudinal cohort studies in an application and summarily denied it if those weren’t present. The FDA has maintained that it later rescinded this method, around two weeks before the September 2021 decision deadline. Todd Wages, a partner at Triton, told Filter that the company informed the FDA that it would complete those studies but would need time to do so.
The FDA has enforcement discretion to act on any vapor manufacturer but has effectively allowed companies with pending PMTAs to keep selling their products as they remain under consideration—unlike those that have already received denials.
Heyer essentially claims that the FDA formed a new standard after the PMTA deadline, likely to dig itself out of mounds of paperwork. He argued on January 31 that the agency should have considered the whole PMTA—including Triton’s marketing plan and survey data that showed youth did not use the company’s vaping products—but did not, instead relying on that “Fatal Flaw” rejection strategy. He has asked the court to vacate Triton’s denial.
Should that happen, the Fifth Circuit judges on the case—Edith Jones, Gregg Costa and Catharina Haynes, not the three behind the October opinion—could create a precedent for the dozens of similar lawsuits, potentially leaving the FDA to re-review thousands of PMTAs.
Basically, there are three possible outcomes: The court upholds the FDA’s denial; allows Triton some time to complete long-term studies; or court vacates the denial.
But that’s far from certain. “There might be some type of relief for Triton, but what that means is the big question I think the court will struggle with,” a vaping industry insider, who requested anonymity so as not to affect the PMTA process, told Filter. “Telling the FDA they screwed up isn’t a meaningful or helpful remedy with ramifications that force a policy change,” they continued. “So what the court is able to do, and what that means for anyone else, is so up in the air. I’m sure the FDA is confident they’ll be unscathed, which is why they fought this and other cases.”
If the court disagrees with him, Heyer has requested that the judges “enjoin FDA from taking further adverse action on the Petitioners’ PMTAs for 18 months to allow Petitioners to conduct the necessary studies to prove comparative efficacy,” according to legal documents.
Basically, there are three possible outcomes: The court upholds the FDA’s denial, and Triton can no longer sell its products; the court allows Triton some time to complete long-term studies (and could potentially keep selling its products in the meantime); or the court vacates the denial, putting the PMTA back under review to be reevaluated over an indeterminate period.
Either way, it’ll end up back in the hands of the FDA—in a system that many in the industry maintain is broken. A “win” for Triton, in other words, might not necessarily be a win.
“It’s like going to a general practice doctor for a complex cardiac issue.”
At the hearing, Fifth Circuit Judges Jones, Costa and Haynes did not appear to be subject-matter experts. When Heyer presented a variety of different vaping products, Jones asked how to “ignite” them. And for whatever reason, Costa believed that the FDA had already authorized tobacco-flavored vaping products across the board.
“It’s like going to a general practice doctor for a complex cardiac issue,” another vaping industry insider, who also requested anonymity so as not to affect the PMTA process, told Filter.
But while the judges also harped on a supposed youth vaping crisis despite youth vaping rates substantially waning in recent years, they did not let the FDA off the hook. Jones in particular grilled the FDA’s counsel, Noah Katzen, about why the agency did not appear to evaluate Triton’s marketing plan and if the FDA was, in fact, applying a de facto blanket flavor ban without saying so.
“FDA ought to say, since the state of the science is inconclusive whether flavored products assist smokers in stopping to smoke in a robust way that overbears the attractiveness to youth, then we are not going to approve any applications,” Judge Jones said during the oral arguments, wondering if the agency was indirectly instituting a flavor ban. “If FDA is going to rely on inconclusiveness, then you’re making thousands of these producers waste thousands and thousands of dollars on what is a fruitless exercise. Or a flavorless exercise.”
Triton now awaits the court’s decision, which could take weeks or months.
Photograph by John via Flickr/Creative Commons 2.0