FDA Has Rescinded its Marketing Denial Order Against Turning Point Brands, Inc
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In an incredible turn of events, the Food and Drug Administration (FDA) has rescinded, or reversed, its Marketing Denial Order (MDO) against Turning Point Brands, Inc. The move by the FDA comes after Turning Point Brands, Inc issued a federal appeal against the FDA to review its decision of denying the company a marketing order for 490 of its vape products.
Table of Contents:
- The Appeal by Turning Point Brands, Inc.
- The Decision to Rescind the Marketing Denial Order by the FDA
- What This Means for the PMTAs
- Conclusion
The Appeal by Turning Point Brands, Inc.
The appeal, which was filed on September 23 by Turning Point Brands, Inc, asked the Sixth U.S. Circuit Court of Appeals to review Marketing Denial Orders of Premarket Tobacco Applications (PMTAs) for various flavored e-liquids made by Turning Point Brands, Inc (TPB). Among these included products by the brands: Solace, Vapor Shark, and VaporFi.
The appeal stated that the FDA Marketing Denial Order should be reviewed once more “on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.”
Almost a week later, on September 30, Turning Point Brands, Inc asked the court in which they had filed the appeal for a stay of the FDA denial order, so they could continue selling products while the court reviewed the decision by the FDA.
The stay also asked for an expedited review of the FDA’s decision and provided a few of the reasons why they considered the decision by the FDA unjust. In the motion, Turning Point Brands, Inc goes on to say that “FDA repeatedly instructed the industry that, to obtain marketing authorization, they did not need to produce long-term studies. Instead, FDA recommended submitting scientific-literature reviews, consumer-perception studies, or other alternatives to show that ENDS products are ‘appropriate for the protection of the public health.”
However, when the FDA explained its reasons for denying the marketing order, the FDA when on to say that, according to TPB, Inc, “FDA reasoned that TPB failed to conduct ’a randomized controlled trial and/or longitudinal cohort study’ or other studies performed ‘over time’ to show that TPB’s specific flavored products help adult users stop smoking more than tobacco-flavored products do, yet FDA previously deemed these studies unnecessary, and FDA rejected TPB’s other studies as inherently unreliable, even though FDA previously encouraged these studies. The Administrative Procedure Act (APA) forbids FDA from engaging in that bait-and-switch.”
The Decision to Rescind the Marketing Denial Order by the FDA
After the appeal was submitted by TPB, the FDA changed its tune. On Friday, October 8th, the appeal by Turning Point Brands, Inc was withdrawn because the company had received a communication on Thursday, October 7, from the FDA that their products were back in review.
In the letter, the FDA explained its reasons for why they were reversing their decision of giving TPB a marketing denial order.
“Upon further review of the administrative record, FDA found relevant information that was not adequately assessed, 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.” the letter goes on to state that “Accordingly, this letter rescinds the September 14, 2021, marketing denial orders for your tobacco products.”
The letter also touches upon enforcement action by the FDA, stating that “in light of the unusual circumstances,” the agency “has no intention of initiating an enforcement action against any of 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.”
What This Means for the PMTAs
The news gives a sliver of hope to the vaping industry, which this year has faced tremendous obstacles. Since the deadline of the PMTAs has gone by, the FDA has denied market orders to 323 vape manufacturers. Still, there are many vape manufacturers that have filed appeals, and this recent reversal could create a precedent for how the FDA plans on dealing with the vape manufacturers that plan to seek legal action against the FDA.
Although there aren’t any guarantees that a month from now, the FDA will give the same verdict to the PMTA application of Turning Point Brands, Inc, this very important move by the FDA could open the floodgates for other companies to seek the same route in order to be put back in the review process. However, the decision is still in the hands of the FDA, and while the reversal is important, there is also the possibility that this could be a one-off case.
A vapor industry insider stated on Alex Norcia’s (the reporter who broke the news) Blog, The No Smoking Section, that “This is a scenario we thought about,” adding that “presumably they’ll offer the same sort of deal to everybody.”
Conclusion
The decision to rescind the Marketing Denial Order against Turning Point Brands, Inc, is an important development for the continuity of flavored vaping products. As of now, at least two companies are taking the same legal route, with Wages and White Lion Investments (Triton Distribution) creating an appeal with the same court and issuing an appeal to stay similar to the one created by Turning Point Brands, Inc.
