Top Takeaways:
- FDA set Dec. 8, 2025 as the deadline for public comments on Philip Morris Products S.A.’s MRTP renewal applications for multiple IQOS heated tobacco products.
- The applications cover IQOS 3.0, IQOS 2.4, and Marlboro HeatSticks, each assigned to separate FDA dockets.
- FDA will consider public comments, TPSAC recommendations, and all relevant evidence before ruling on the renewals, following an Oct. 7 TPSAC review meeting.
The U.S. Food and Drug Administration has announced December 8, 2025 as the closing date for public comment on a series of modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products S.A. for several IQOS heated tobacco products already authorized for sale in the United States.
The agency said comments must be submitted by 11:59 p.m. Eastern Time to the appropriate federal docket to be considered as part of FDA’s review.
The renewal applications are filed under the following dockets:
- 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
FDA has posted redacted versions of the application materials on its website, consistent with federal disclosure laws governing proprietary and confidential information.
Under the Tobacco Control Act, the agency must evaluate whether the scientific evidence submitted continues to support an MRTP order for each product. As part of that process, FDA considers all relevant information, including public comments, external scientific input, and recommendations provided by the Tobacco Products Scientific Advisory Committee (TPSAC).
TPSAC convened on October 7, 2025, to discuss the IQOS renewal applications. The meeting, which was open to the public for virtual attendance, included opportunities for stakeholders and members of the public to provide oral comments. FDA has posted the meeting materials—including presentations and background documents—on its website.
The agency has not indicated when it expects to complete its review or issue decisions on the renewal applications.
