PMTA and MRTP: navigating the path to FDA approval for reduced-risk products



  • Executive summary
  • Background
  • Legal framework
  • The PMTA and MRTPA for iQOS and Heets
  • Premarket Tobacco Product Applications (PMTA)
  • PMI’s PMTA application
  • What we expect
  • Modified Risk Tobacco Product Applications (MRTPA)
  • What do we expect
  • A practical example: snus
  • Potential regulation of HnB beyond the PMTA
  • The substantial equivalence route: an alternative to PMTAs


As PMI’s iQOS comes under consideration by the US FDA, we examine the hurdles it – and other – heated tobacco and e-cigarette products will have to clear to obtain authorisation for commercialisation and reduced-risk claims.

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