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Philip Morris Products S.A. Modified Risk Tobacco Product (MRTP) Applications

To Comment on the IQOS 3 MRTP Application

Submit comments including data, research, and other related information to docket FDA- 2021-N-0408 through December 10, 2021.

There may be conflicting deadlines posted on regulations.gov and federalregister.gov. While we cannot control how information is displayed on those websites, the docket will remain open through December 10, 2021.

FDA notified Philip Morris Products S.A. (PMPSA) that the applicant’s modified risk tobacco product (MRTP) application for the IQOS 3 System Holder and Charger is sufficiently complete to permit a substantive review.

Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted or check this webpage regularly. The latest set of application materials from Philip Morris Products S.A. were added on November 10, 2021.

The following application materials have been redacted in accordance with applicable laws:

Originally Submitted Applications:

Cross-referenced Submissions


Previously Reviewed Application(s)

Temporary Compliance Waiver Notice

The linked files may not be fully accessible to readers using assistive technology. We regret any inconvenience that this may cause. In the event you are unable to read these documents or portions thereof, please email [email protected] or call 1-877-287-1373.

Note: 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.

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