Turning Point withdraws legal action after FDA back-tracks on PMTA refusal

The US Food and Drug Administration (FDA) has rescinded its marketing denial order (MDO) affecting 14 Turning Point Brands products, admitting that “relevant information that was not adequately assessed”. The company has responded by putting on hold a legal action against the agency.

In a letter to the vaping manufacturer and distributor, the FDA said the randomised trials and cross-sectional surveys that Turning Point Brands (TPB) presented in its premarket tobacco product applications (PMTAs) required “further review”.


Restricted content. Do you want to read more?