FDA Backs Down, Rescinds Turning Point Brands' MDOs
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 The agency has moved the TPB products back into scientific review, and in response the company has withdrawn its federal court petition for review, according to Filter reporter Alex Norcia.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.
Two more companies appeal MDOs
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.
Jim, this is highly encouraging. Does this mean Turning Point is still not legally sold in the US though?
No, as I noted, the FDA told them it doesn’t intend to enforce while their applications are reviewed.
Yes I did read that. And fully understood. Was just curious about the legal aspect. It’s still illegal even though the FDA won’t enforce. The ATF can still charge for selling unlicensed tobacco, right? Even if the FDA does not intend to enforce. This is all so confusing!
The ATF handles the PACT Act, which applies to all vaping products—whether they contain nicotine or not, and whether they are classified by the FDA as tobacco or not. It’s an entirely separate thing from FDA rules and enforcement.
Right you are Jim. But the ATF prosecutes crimes of selling unlicensed tobacco products do they not? And if stores and distros are selling unlicensed tobacco products(which literally all nicotine vaping is at the moment), the ATF can press charges and take appropriate action. You SHOULD be warning folks that by continuing to sell unlicensed tobacco products they can be charged not only by the FDA, but by the ATF as well. And even though there are idiotic doubts about enforcement, the likelihood of legal action absolutely exists. Folks are taking HUGE risks by continuing to manufacture and sell nicotine… Read more »
ATF’s area is enforcing against manufacturers and sellers that don’t pay state and federal taxes on tobacco products.