On March 31, 2017, PMI submitted a Premarket Tobacco Product Application to the US FDA’s Center for Tobacco Products. The application seeks authorization to commercialize Platform 1 in the United States.

A PMTA marketing order is a prerequisite to commercializing a new tobacco product in the United States. An affirmative decision on the PMTA would allow the marketing of Platform 1 without modified risk or exposure claims and independent of the U.S. FDA’s decision on the MRTPA – Modified Risk Tobacco Product Application – which was submitted for the same platform on December 5, 2016. Our PMTA was accepted for scientific review, which is ongoing.

 

 

 

Applications for Premarket Review of New Tobacco Products | Draft Guidance | FDA

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