U.S FDA Announces Dec. 8 Deadline for IQOS MRTP Renewal Comments

Nov.07

The U.S. FDA has set December 8, 2025, 11:59 p.m. ET as the closing date for public comments on the MRTP renewal applications submitted by Philip Morris Products S.A. for several IQOS heated tobacco products.

Key Points:

Public comments on IQOS MRTP renewals are due by December 8, 2025, 11:59 p.m. ET.
Applications include: FDA-2021-N-0408 (IQOS 3.0) and FDA-2017-D-3001 (IQOS 2.4 and Marlboro HeatSticks).
Redacted application materials are available on the FDA website.
FDA will consider public input and recommendations from TPSAC before final determination.
TPSAC held its meeting on October 7, 2025; meeting materials are now public.

2Firsts, Nov. 7, 2025 — The U.S. Food and Drug Administration (FDA) announced the closing date for the public comment period on 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 by 11:59 p.m. Eastern Time on December 8, 2025, to the appropriate docket to ensure they are considered by FDA.

The relevant docket numbers are:

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.

According to FDA, the application materials—redacted in accordance with applicable laws—are available on the agency’s website. Before making a final determination on any MRTP application, FDA considers 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 on October 7, 2025, to discuss these renewal applications. The public was able to attend virtually and present comments to the committee. All materials from the meeting are posted on FDA’s website.

For ongoing updates on MRTP applications under scientific review, FDA encourages stakeholders to subscribe to its email alert service.

Image Source: FDA

References:

[1] FDA Establishes Closing Date for Public Comments on MRTP Renewal Applications for IQOS Products

Also Read:

[1] US FDA releases MRTP renewal application materials for IQOS heated tobacco product and will hold an expert meeting in October

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