So IQOS has PMTA approval – but what does that mean in practice?

This report will review the most relevant specific conditions that have been imposed upon IQOS and its heat sticks in the approval of its premarket tobacco application (PMTA) by the US Food and Drug Administration (FDA), and the federal framework that applies to it as a tobacco product.

Restrictions listed in this report are not meant to be exhaustive but an indication, mainly for vaping companies, of how the playing field will like for other reduced-risk tobacco products which will be competing against IQOS in the US market.

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Table of contents

  1. Main findings
  2. Scope of this report
  3. Introduction to the PMTA
  4. The conditions laid down
  5. Obligation to maintain and send reports
  6. Age verification
  7. Health warning requirement
  8. The applicable legal framework
  9. Health warning
  10. Packaging
  11. Banned ingredients
  12. Flavours
  13. Advertising
  14. Sales channels
  15. Taxation
  16. Reporting

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