A ‘groundbreaking’ ruling as appeal court orders US FDA to reconsider PMTA denial

In a big win for the vaping industry, a federal appellate court has ordered the US Food and Drug Administration (FDA) to reconsider its denial of premarket tobacco product applications (PMTAs) for six companies.

The 2-1 opinion by the US Court of Appeals for the 11th Circuit says the FDA erred when it issued marketing denial orders (MDOs) to Bidi Vapor, Diamond Vapor, Johnny Copper, Vapor Unlimited, Union Street Brands and Pop Vapor without considering the companies’ plans to prevent children from accessing their products.

Judges William Pryor and Andrew Brasher agreed that the MDOs were “arbitrary and capricious” and sent the PMTAs back to the FDA for further review. Lawyers for Bidi hailed the remand as “groundbreaking” and indicated the company might have a better chance of success in the next review.