The deeming rule and PMTAs: what it all means for manufacturers



  • Introduction
  • Why an ENDS product requires FDA approval
  • Pathways to approval
  • The FDA guidance on PMTAs
  • PMTAs, public health, and scientific studies


In this in-depth report, we look at why ENDS products require FDA approval before detailing the three pathways to FDA market approval, including a look at what is required for premarket tobacco product applications.

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