US FDA rejects 5.5m PMTAs; Juul’s application still under review

The US Food and Drug Administration (FDA) has rejected around 5.5m of the 6m premarket tobacco product applications  (PMTAs) it received for e-cigarette products, with the remainder pending review.

The federal agency announced today that it had issued marketing denial orders (MDOs) for a total of 946,000 applications relating to flavoured vapour products, following on from the “refuse to file” letter that the agency issued in August rejecting 4.5m applications from a single manufacturer.

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      The US Food and Drug Administration (FDA) has rejected around 5.5m of the 6m premarket tobacco product applications  (PMTAs) it received for e-cigarette products, with the remainder pending review.

      The federal agency announced today that it had issued marketing denial orders (MDOs) for a total of 946,000 applications relating to flavoured vapour products, following on from the “refuse to file” letter that the agency issued in August rejecting 4.5m applications from a single manufacturer.

      ...

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      Need help?

      Contact a sales representative right now and don’t wait

      Erik Galavis
      +34 654 320 547
      Email Erik