The assessment of Platform 1 is described in our Modified Risk Tobacco Product Applications to the US FDA
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 The application was prepared in accordance with the Draft Guidance of Industry.
Modified Risk Tobacco Product Applications | Draft Guidance | FDA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.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
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Reduced Risk Products (“RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. Our RRPs are smoke-free products that produce an aerosol that contains far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.