A guide to the FDA’s premarket tobacco applications (PMTAs)



  • Introduction
  • Overview of the application
  • Labelling and marketing
  • Health risk investigations
  • How the PMTA will be assessed
  • Industry concerns
  • Submission success


The FDA has now issued its proposed rule for pre-market tobacco product applications (PMTA), with detailed advice and guidance on this demanding and rigorous process for applicants preparing to submit their applications. This report provides a concise overview of the proposed rule as well as how the applications are assessed.

Published: 25th November 2019; No. pages: 20