The FDA has reversed the Marketing Denial Order (MDO) it issued for some Turning Point Brands e-liquids. The agency has moved the TPB products back into scientific review, and in response the company has withdrawn its federal court petition for review, according to Filter reporter Alex Norcia.
Norcia broke the new todays in his blog, which includes a copy of the letter sent Thursday to TPB from FDA Center for Tobacco Products Office of Science Director Matthew Holman. In the letter, Holman claimed the agency had somehow overlooked the scientific evidence the company submitted with its Premarket Tobacco Applications (PMTAs)—which is difficult to believe.
“Upon further review of the administrative record, FDA found relevant information that was not adequately assessed,” wrote Holman. “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 FDA announced on Aug. 26 that PMTAs for products in flavors other than tobacco and menthol would face a higher evidentiary standard to earn authorization. TPB received an MDO for 490 of its products on Sept. 14, and filed a petition for review with the Sixth U.S. Circuit Court of Appeals on Sept. 23. The company then filed an emergency motion with the same court on Sept. 30, asking for a stay preventing the FDA from enforcing its MDOs.
Holman went on to say in his letter that, “in light of the unusual circumstances,” the FDA has no intention of initiating enforcement actions against the products under review, and would first issue a warning letter to the company if it decided to enforce (which is the typical FDA practice).
The FDA reversal applies to TPB only, and there is no indication the agency’s decision will apply to other companies that have appealed MDOs in federal court. Yesterday the FDA issued warning letters to 20 companies for selling products that have received MDOs. The FDA has so far issued MDOs to 323 vape manufacturers.
In the last week, two additional companies have filed appeals of their marketing denials. SWT Global Supply, Inc. (Hooligan Vapes) and Wages and White Lion Investments (Triton Distribution) both petitioned the 5th Circuit Court of Appeals for review, and Triton also asked the court to issue a stay, preventing FDA enforcement while the case is decided.