Tobacco Products

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

To Comment on the Philip Morris Products S.A. MRTP Application Docket

Comment online at regulations.gov, docket FDA-2017-D-3001. You may submit data, research, and other related information by December 12, 2017. We cannot guarantee consideration of comments received after that date.   

The FDA filed for scientific review three Modified Risk Tobacco Product (MRTP) Applications from Philip Morris Products S.A. (PMP S.A.) for its IQOS system and three types of Heatstick products on May 24, 2017.

Due to the large size of these applications, the FDA is posting the application documents in installments on a rolling basis as they are redacted in accordance with applicable laws. The following modules are currently publicly available:

The Table of Contents documents in Module 2 have detailed information about all application modules. All publicly available modules are complete, meaning no modules have been split between separate installments. Future installments will also include complete modules.

Over the next several months, we anticipate making additional materials publicly available, posting Module 7 next.  Amendments received from the applicant will also be posted. Please note that Module 9 contains full articles referenced elsewhere in the applications. This material is subject to copyright protections and will not be posted.

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: The 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.

Page Last Updated: 08/01/2017
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