Regulatory report: Q&A – US FDA final guidance on PMTAs and SE reports

On 4th October 2021 the US Food and Drug Administration (FDA) issued two final rules providing additional information on the requirements for Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) reports. This report aims to answer questions that may be raised on this topic, in particular taking into account the public comments and responses the FDA has offered.

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Table of contents

  1. Introduction
  2. What are these final rules? Are there any significant changes to the status quo?
  3. What happens to my application if it was submitted before the guidance was published?
  4. What the actions may the FDA take on my PMTA application?
  5. Are there any pointers the FDA follows to refuse to accept a PMTA for initial review?
  6. What factors does the FDA look at to grant a PMTA?
  7. How can I get my flavoured product approved?
  8. When will the FDA issue an MDO?
  9. If I get an MDO, may I re-submit an application?
  10. Once I get a PMTA, can my product remain on the market forever?
  11. Is there any danger my MGO might be withdrawn?
  12. What if the business has been transferred and I now own an application that was submitted before I owned it?
  13. Is there any reference to synthetic nicotine?
  14. How can I go through the SE route?
  15. May I go via the SE route if I have a PMTA and then modify it?

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