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

To Comment on the IQOS 3 MRTP Application

Beginning on May 14, 2021, you may submit comments including data, research, and other related information to docket FDA- 2021-N-0408. There is currently no deadline for public comments.

Once all materials from this MRTP application, including amendments, are posted, FDA will announce the closing date for the comment period, which will be both at least 45 days from the date the related Federal Register notice is published and at least 30 days from the date the last application materials are posted.  

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 May 13, 2021.

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

Originally Submitted Applications:

Amendments

We anticipate making amendments publicly available after they are redacted. 

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 AskCTP@fda.hhs.gov 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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