On October 26, a United States federal court of appeals granted a full stay for vapor company Triton. This will allow Triton, which received a marketing denial (MDO) from the Food and Drug Administration (FDA) in September, to continue selling its products while a petition for review weaves its way through the judicial system. It’s the first full stay of its kind for a vapor company.
The decision has been met with praise and mockery from consumer advocates and the industry, who have long criticized the FDA for an onerous premarket tobacco product application (PMTA) process that favors well-financed corporations over mom-and-pop businesses.
Regulating an industry with thousands of producers and millions of consumers clearly has its challenges. Triton’s full stay, which includes a scathing opinion from a panel of judges, is an early indication that the US war on vaping won’t be over anytime soon, and that mounting legal challenges will likely force the FDA into more substantive decision-making.
One industry insider described the Triton stay as the “We Vape We Vote” moment of the Biden era, in which vape companies—endlessly back into a corner, but not giving up—managed to strike back.
In September 2020, Triton, like every vape manufacturer, had to submit an expensive and laborious PMTA for every product it wanted to keep on the market. The FDA had until September 2021 to review them.
The threshold for authorization centered on each product being “appropriate for the protection of public health”—unhelpful bureaucratic vernacular that eventually came to be understood as facilitating adult smokers’ transition to safer alternatives, without attracting a new generation of nicotine users.
By late summer, the agency had denied most of the small and midsize manufacturers, and punted on the larger players by saying those applications required more time. Dozens of vape producers subsequently filed lawsuits against the FDA. Many of them are arguing that the agency acted in an “arbitrary and capricious manner,” repeatedly altering PMTA requirements without allowing manufacturers to address the changes—so much so that a guideline for those applications appeared online after the filing date had passed.
Now, at least one court seems to agree. By issuing a full stay, the three-judge panel determined that Triton “will ultimately succeed” in its petition. If that were to happen, the company’s products would be remanded back to the FDA.
Triton’s full stay does not guarantee it will ultimately receive authorization. Nor does it ensure, should the company’s products go back under review, that the process would be completed in a timely fashion once resumed.
In copy-pasting all its MDOs, the FDA apparently failed to consider they could all be rebutted the same way.
The judges’ opinion—which could have been a single line instead of 20 blistering pages—eviscerated the FDA for bungling its regulatory power. It leveled the accusation that the agency had “simply ignored Triton’s [marketing] plan” and “pull[ed] a surprise switcheroo” by demanding long-term studies that companies did not anticipate.
It continued by stating that “the public-interest factor is at worst neutral,” meaning that no one really believes youth vaping rates will soar if Triton’s products remain on the marketplace.
There are two probable outcomes for Triton. In the first, the company’s lawyers approach the FDA and Department of Justice, asking for a full-blown rescission like those issued to Turning Point Brands (TPB) and Fumizer. In the second, the petition for review continues in court, and federal judges determine whether or not to vacate Triton’s original MDO and put the review back in the hands of the FDA.
An FDA spokesperson stated to Filter that the agency does not comment “on possible, pending or ongoing litigation.”
The more the PMTA denial saga develops, the more it seems like the FDA shot itself in the foot. By issuing MDOs through what looks to be a single, one-size-fits-all template, the agency didn’t provide any companies with explanations for why their products were denied.
Future appeals courts will likely make similar decisions, and those judges can apply this same rationale to every single denied product, because they were all denied interchangeably. Essentially, the FDA copy-pasted all of its MDOs, apparently failing to consider that they could all be rebutted the exact same way.
“This is a major recognition by three federal appeal court judges that the FDA badly bungled their application reviews for flavored vaping products,” Greg Conley, the president of the American Vaping Association (AVA), told Filter. “The court’s direct and concise opinion should be highly influential to other judges considering similar cases.”
The Influence Foundation, which operates Filter, has received unrestricted grants from the American Vaping Association. Filter’s Editorial Independence Policy applies.
Photograph by Blogtrepreneur via Flickr/Creative Commons 2.0
Show Comments