Court allows firm to continue e-cig sales after ‘inadequate’ FDA denial order

The US Court of Appeals for the Fifth Circuit concluded that the Food and Drug Administration (FDA) “inadequately addressed or explained” a premarket tobacco product application (PMTA) that resulted in a marketing denial order (MDO), and decided to temporary allow a company from Texas to keep its flavoured products on the market until it resolves the case.

In a 20-page opinion, the court states that the federal agency did not properly address the marketing plan from Triton Distribution to reduce the products’ appeal to youth – something that was “a critical factor” for the FDA, according to the judges – and the evidence on the potential benefits of flavoured e-cigarettes.

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      The US Court of Appeals for the Fifth Circuit concluded that the Food and Drug Administration (FDA) “inadequately addressed or explained” a premarket tobacco product application (PMTA) that resulted in a marketing denial order (MDO), and decided to temporary allow a company from Texas to keep its flavoured products on the market until it resolves the case.

      In a 20-page opinion, the court states that the federal agency did not properly address the marketing plan from Triton Distribution to reduce the products’ appeal to youth – something that was “a critical factor” for the FDA, according to the judges – and the evidence on the potential benefits of flavoured e-cigarettes.

      ...

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      Need help?

      Contact a sales representative right now and don’t wait

      Erik Galavis
      +34 654 320 547
      Email Erik