In a decision that could shake up the FDA’s premarket review process for vaping products, a federal court has granted a stay to Triton Distribution, preventing FDA enforcement of the agency’s Marketing Denial Order (MDO).
A three-judge panel on the 5th Circuit Court of Appeals found that Triton (also known as Wages and White Lion Investments, LLC) is likely to succeed in its MDO appeal, and that the FDA order is “likely arbitrary, capricious or otherwise unlawful.”
The decision allows Triton to continue selling its products while the court reviews the FDA denial order.
This is the first stay issued by a court in a legal challenge to the agency’s MDOs, although the FDA itself has stayed enforcement for some companies pursuing internal administrative appeals, and has rescinded marketing denials issued to Turning Point Brands and Fumizer based on “overlooked” evidence, and promised to delay enforcement against them until their reviews are complete.
Jim McDonald – Vaping360.com – 2021-10-28.
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