On October 20, My Vape Order (MVO) petitioned a federal court of appeals for “an emergency motion for a stay pending a review and for expedited consideration” on the company’s vapor products that have been removed from the market.
In early September, the Food and Drug Administration (FDA) had issued a marketing denial order for MVO’s products. Like all other vape companies in the United States, MVO had until September 2020 to file premarket tobacco product applications (PMTAs) to be able to keep selling its vapes and e-liquids; the FDA, in turn, had until September 2021 to review the PMTAs.
The FDA missed its deadline to make decisions on the biggest vape companies’ products; it has subsequently approved just one. The agency has meanwhile issued marketing denial orders (MDOs) to numerous smaller players—and many of them are now pushing back against a process that has caused widespread anger.
Court documents paint the PMTA process as even more chaotic and unfair than critics have long maintained.
MVO initially filed a petition for review in the Ninth Circuit Court of Appeals at the end of September, as dozens of other vapor companies have done. Most have argued, in part, that the FDA’s denials were “arbitrary and capricious,” and that, in rushing to meet a court-imposed deadline, the agency overlooked vital information. Many manufacturers, too, have repeatedly complained of the FDA shifting its goal posts—and offering guidance on certain studies only after PMTAs had been filed.
As a result, MVO, like many other smaller companies, sits on the brink of financial collapse. “This financial harm is unrecoverable, as FDA, as a federal government agency, enjoys sovereign immunity,” MVO’s lawyers write.
Now, MVO’s attorneys are demanding that the appeals court grant a judicial stay for the company’s denied products by the end of October. In court documents reviewed by Filter, they paint the PMTA process as even more chaotic and unfair than critics have long maintained.
“In preparing and submitting its PMTA, MVO understandably relied on FDA’s many representations, including FDA’s statements that long-term studies would not be required for a successful PMTA,” the petition reads. “Nevertheless, FDA based the MDO on MVO’s purported failure to include long-term comparative efficacy data for its flavored ENDS products versus tobacco-flavored ENDS products in the form of a randomized controlled trial or longitudinal cohort study. In so doing, FDA ignored four randomized controlled abuse liability studies included in MVO’s application and summarily rejected without consideration other observational studies MVO included.”
“FDA’s about-face from its prior representations violates fundamental principles of administrative law,” the document continues.
In the span of a few weeks, between MVO’s original petition and its emergency motion, there’s been a notable development: The FDA rescinded an MDO for Turning Point Brands (TBP) because it identified “relevant information that was not adequately assessed” in the PMTA. TPB, which had petitioned a federal court a few weeks earlier
, then withdrew a similar appeal it had filed in a federal court. So far, this has been the only such rescission.
But as it turns out, lawyers for MVO revealed that their client had “collaborated extensively”—“shared studies and data”—with Twelfth State Brands, a CBD and vapor manufacturer, as well as TPB. (Twelfth State’s PMTA remains pending.)
In other words, counsel for MVO is essentially arguing that the company has not received the same treatment as TPB and TSB, even though the applications literally contained some of the same information. As competitors, the logic goes, this does not place them “on a level playing field.” (Through an attorney, MVO declined to comment on the pending litigation.)
The backlash to a derided process, on which millions of former smokers depend, is only growing.
Here’s the bureaucratic nightmare in a nutshell: Following the TPB reversal, as MVO’s lawyers explain, they approached the FDA to indicate that they planned to file an emergency motion for a stay. The agency then signaled that it “would entertain a request by MVO that FDA re-review its PMTA to determine whether a rescission of the MDO like that afforded to [TPB] was appropriate.”
The FDA appeared to want to head off legal action by dangling the prospect of a stay through its own internal procedure. The FDA did eventually grant the administrative stay, but would not define how long its “re-review” could last. Basically, it would be at the whim of the agency. In contrast, a judicial stay, which MVO is now seeking at an expedited pace, would guarantee the company can sell its denied products while its initial lawsuit works its way through the court.
Consumer advocates, vape producers and tobacco harm reductionists have looked to the FDA’s Turning Point Brands reversal as a precedent of sorts. The problem, though, is that TPB’s PMTA is not publicly available, so other manufacturers are left to guess how the company managed to get the agency to backtrack. If My Vape Order’s submissions contained some of the exact same information, that reduces the guesswork. But will it be enough?
It’s still unclear if the FDA will rescind any other MDOs. The extent to which other manufacturers may have shared PMTA information with each other is also unknown. But if some companies received MDOs on the basis of data that was also used by companies that didn’t get denied, how and why did this happen?
What is clear is that the PMTA saga is far from over—and that the backlash to a derided process, on which millions of former smokers depend, is only growing.
Photo by John Caroro on Unsplash