Turning Point Brands' PMTAs Are Back Under FDA Review
Some breaking news: TPB is withdrawing its lawsuit in a federal court of appeals.
On Friday, Turning Point Brands, which late last month petitioned a federal court to review a marketing denial order (MDO) for many of its vapor products, is withdrawing its appeal. The company is doing so because, on Thursday, the Food and Drug Administration informed TPB the products that had been denied are now back under review.
“Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” reads a letter addressed to Brittani Cushman, TPB’s senior vice president of external affairs, and signed by Matthew Holman, the director of the office of science at the FDA’s Center for Tobacco Products. “Specifically your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.”
“Accordingly,” it goes on, “this letter rescinds the September 14, 2021, marketing denial orders for your tobacco products.” (Full letter attached below.)
The FDA also stated that, “in light of the unusual circumstances,” the agency “has no intention of initiating an enforcement action against any of [TPB’s] tobacco products identified” and if it “were to later seek to initiate an enforcement action … as to any of those products, it would first send a warning letter.”
That’s a rather large clerical error. And while victory laps might be premature, the news will certainly inspire a shred of optimism in an industry that’s recently been starved of it. (There’s no guarantee, for example, that the FDA won’t draw the same conclusion a month or two down the line.) Still, the decision is a startling reversal, and probably one that will be met with the usual criticism from mainstream tobacco control groups like the Campaign for Tobacco-Free Kids. Even, as we all know, youth vaping rates have yet again decreased in 2021.
It’s also an open question if the FDA will soon offer this kind of do-over to the other vapor companies that have petitioned the court, like Triton, which filed a similar lawsuit and an emergency motion for a stay — meaning its products could remain on the market while the case worked its way through court. In other words, the situation is still unclear: Is this a business-to-business decision, or will this be a blanket move by an agency that was likely rushed to get decisions out by a court-imposed deadline?
Stemming from a federal lawsuit by some public health organizations, the FDA had until early September to review the premarket tobacco product applications (PMTAs) of vape manufacturers who wanted to remain legally on the market. The agency has since denied a large swath of applications from most small- to medium-size producers by issuing MDOs, while indicating more time was needed to consider larger players like JUUL.
“This is a scenario we thought about,” said another vapor industry insider, who requested anonymity so as not to potentially affect the PMTA process. “Presumably they’ll offer the same sort of deal to everybody.” (Others in the industry have been surprised that the FDA did have a sort of internal review process readily available, to avoid the courts.)
For the past month, many consumer activists and vape producers have grown concerned that the FDA has been effectively inching toward a de facto flavor ban. This development, however, might restore some hope in the short term that the FDA is not operating with that rationale.
UPDATE (Friday, 10/8/21): The following statement was received after the newsletter’s publication: “On October 7, 2021, FDA issued a rescission of denial letter to TPB International, LLC, who submitted applications for their new tobacco products to FDA to obtain premarket authorization,” an FDA spokesperson said. “With this rescission, the company’s tobacco products are placed back into the review process.”
Here’s the full letter:
