iQOS MRTP Application

iQOS MRTP Application

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Philip Morris International (PMI) has filed a Modified Risk Tobacco Product Application to the FDA for its iQOS system. The Tobacco Control Act requires FDA authorization before any manufacturer can make statements that claim that its product is less harmful or presents a lower risk of disease than other tobacco products. The Act also requires that the FDA make the application materials available and accept comments on them. To view PMI’s application, visit the FDA’s website. The FDA has commissioned the Tobacco Products Scientific Advisory Committee (TPSAC) to comment on the application at the committee’s meeting on January 24-25, 2018.Members of the public health community can submit comments on the merits of this application. You can submit your comment on Regulations.gov. The FDA has not yet announced a final deadline for comments but in order for comments to be considered by TPSAC, they must be submitted by January 4, 2018. 

 

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