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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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.

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