Court Lets Four FDA-Denied Vape Companies Resume Sales, for Now

On February 1, the Eleventh Circuit Court of Appeals granted four nicotine vape manufacturers—Bidi Vapor, Diamond Vapor, Johnny Cooper and Vapor Unlimited—judicial stays on their marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA).

The decision means that these producers can continue selling their harm reduction products while the lawsuits remain active.

They followed dozens of other vape companies in taking legal action against the FDA, after the agency denied thousands of products through its new premarket tobacco product application (PMTA) pathway. In the PMTA process, the FDA has to determine whether submissions are “appropriate for the protection of public health”—a hazy standard that has now come to be understood as a given product’s likelihood of helping adult smokers transition to safer alternatives while not introducing a new generation to nicotine.