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 navigate the scientific data and research studies that have to be conducted.

Free sample
I'm already a subscriber

Berta Camps Bisbal

Senior legal analyst
Berta has a law degree from the University of Barcelona and a Juris Doctor degree from Nova Southeastern University (Florida). She has worked as a faculty assistant in legal research in Florida, was a member of the Law Review, and has interned for a magistrate judge of the US District Court for the Southern District of Florida. Berta focuses on US legal analysis, including tracking all federal, state and local regulation. She runs our US interactive regulatory tracker product, following changing regulation on e-cigarettes in all 50 US states.

Our Key Benefits

The global novel nicotine market is in an opaque regulatory environment that requires professionals to be on top of industry developments to make informed decisions and optimise their strategy.

TobaccoIntelligence provides organisations with leading market and regulatory data analysis to anticipate and understand market developments globally and the impact of regulatory changes to the business.

  • Stay informed of any legal and market change in the sector that impacts your organisation
  • Maximise resources by getting market and legal data analysis daily in one place
  • Make smart decisions by understanding how the regulatory and market landscape evolves
  • Anticipate risks in your decisions by monitoring regulatory changes that impact your organisation