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The US Food and Drug Administration (FDA) has rescinded its marketing denial order (MDO) affecting 14 Turning Point Brands products, admitting that “relevant information that was not adequately assessed”.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”.

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      The US Food and Drug Administration (FDA) has rescinded its marketing denial order (MDO) affecting 14 Turning Point Brands products, admitting that “relevant information that was not adequately assessed”.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”.

      ...

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      Need help?

      Contact a sales representative right now and don’t wait

      Erik Galavis
      +34 654 320 547
      Email Erik