Triton May Sell ENDS Pending MDO Review
Wages and White Lion Investments, parent to Triton Distribution, may continue to market its electronic nicotine delivery system (ENDS) devices in the U.S. until its appeal against the Food and Drug Administration’s marketing denial orders (MDO) has been evaluated in court.
On Oct. 15, the U.S. Court of Appeals for the Fifth Circuit put the MDO on hold pending review. The judges also granted motions to expedite the appeal case and a ruling for emergency relief.
Triton Distribution filed a motion to stay after the FDA denied the company’s premarket tobacco product application. The company claims that it had been irreparably harmed as a result of the FDA’s actions and faced an imminent shutdown of its business.
In its motion, Triton contends that the FDA retroactively changed the requirements for PMTAs. “By imposing a new, across-the-board requirement that flavored ENDS products be demonstrably more effective at promoting smoking cessation than otherwise identical tobacco-flavored products, FDA acted contrary to its authority under Section 910 of the Food, Drug and Cosmetic Act (“FDCA), 21 U.S.C. § 387j, and not in accordance with law,” Triton wrote.
At least six companies have filed lawsuits challenging the agency’s decision to make the companies remove their products from the market. Last week, the FDA rescinded the MDO issued to Turning Point Brands and the company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s PMTA.