The FDA has filed for scientific review three Modified Risk Tobacco Product (MRTP) applications from Philip Morris Products S.A. (PMP S.A.) for its IQOS system and three types of Heatstick products.
- PMP S.A. Executive Summary (PDF – 5.74 MB)
- PMP S.A. Summaries of Research Findings on IQOS & Heatstick Products (Zip – 75.4 MB), including:
- Module 1: Cover Letters
- Module 2: Table of Contents (includes 208 page executive summary)
- Module 5: Environmental Impact
- Module 6: Summarizes of all research findings (>1,000 pages)
- Module 8: Postmarket Surveillance and Studies
Temporary Compliance Waiver Notice
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Note: The FDA is required by section 911(e) of the Federal Food Drug & Cosmetic Act, as amended by the Tobacco Control Act, to make MRTP applications available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments on the information contained in the applications and on the label, labeling, and advertising accompanying the applications.