Today (November 6, 2025), FDA established the closing date for the public comment period on the modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products S.A. for several IQOS heated tobacco products. Public comments on these applications must be submitted to the appropriate docket by 11:59 p.m. ET on December 8, 2025, to ensure they are considered by FDA:
- FDA-2021-N-0408 (IQOS 3.0 System Holder and Charger)
- FDA-2017-D-3001 (IQOS 2.4 System Holder and Charger and Marlboro HeatSticks products)
The application materials, redacted in accordance with applicable laws, can be found on FDA’s website. Before making a final determination on an MRTP application, FDA takes into consideration all relevant information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC).
FDA held a TPSAC meeting to discuss these renewal applications on October 7, 2025. The public was able to attend virtually and present comments to the committee. Materials from the meeting are available on FDA’s website.
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