PMTA, MRTP and SE: the main pathways to market for tobacco products in the US

In order to launch products in the market, companies must first have their premarket tobacco product applications (PMTA) approved by the Food and Drug Administration (FDA). Alternatively, the substantial equivalence (SE) route may be taken if the requirements are met. In addition to a PMTA, companies may further submit a modified risk tobacco product application (MRTPA), allowing them to make claims about modified risks of their approved products.

This report examines these main pathways for tobacco products to enter the market in the US. It is not a comprehensive guide to navigating the scientific data and research studies that have to be conducted.

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Table of contents

  1. Executive summary
  2. The PMTA
  3. The MRTPA
  4. Differences between a PMTA and an MRTP
  5. The substantial equivalence route: an alternative to PMTAs

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