On 5th December 2016, PMI submitted a Modified Risk Tobacco Product application to the US FDA’s Center for Tobacco Products. The application was prepared in accordance with the Draft Guidance of Industry.

Modified Risk Tobacco Product Applications | Draft Guidance | FDA

Our application reflects the thorough scientific evaluation that has been conducted on the potential risk reduction profile of Platform 1 compared to cigarettes.


The US FDA was the first regulatory agency in the world to establish a framework for the submission of data necessary to authorize reduced-risk and/or reduced-exposure product claims. On January 24, 2018, PMI presented the Modified Risk Tobacco Product Application for Platform 1 before the Tobacco Products Scientific Advisory Committee (TPSAC). 

On June 8, 2018, PMI submitted additional clinical results to the FDA to add to the extensive body of evidence already presented to the agency.

The scientific review of our applications is ongoing.

 

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