Two e-cigarette companies win appeal and resubmit their PMTAs

According to Bloomberg, two e-cigarette companies will have the chance to resubmit their marketing applications to the U.S. Food and Drug Administration.

On January 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” when it rejected the premarket tobacco product applications (PMTAs) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia, both of which had sought approval to sell their products in the United States.

In an opinion by Judge Andrew S. Oldham, the court said the FDA had “sent flavored e-cigarette manufacturers on a wild goose chase,” telling them what was required for approval and then denying every application. Oldham said the FDA “never fairly told applicants that they needed to conduct long-term research on their specific flavored products.”

In a dissenting opinion, Judge Catharina Haynes said the agency “properly discharged its statutory duties by considering the relevant portions of the applicants’ PMTAs and reaching a reasonable conclusion that marketing the applicants’ products would be inappropriate for the protection of public health.”