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.

...

Benefits of subscription plans:

  • Stay informed of any legal and market change in the sector that impacts your organization
  • Maximise resources by getting market and legal data analysis daily in one place
  • Make smart decisions by understanding how the regulatory and market landscape evolves
  • Anticipate risks in your decisions by monitoring regulatory changes that impact your organization

Need help?

Contact a sales representative right now and don’t wait

Erik Galavis
+34 654 320 547
Email Erik