Tobacco Products

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

To Comment on the Philip Morris Products S.A. MRTP Applications

You may submit comments including data, research, and other related information to docket FDA-2017-D-3001. 

On November 21, FDA issued a notice in the Federal Register extending the comment period for the Philip Morris Products S.A. MRTP applications. Once all documents from these MRTP applications, including amendments, are posted, FDA intends to issue another notice in the Federal Register announcing when the comment period will close, which will be at least 30 days from the date the last application documents are posted.

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, FDA is posting the application documents in installments on a rolling basis as they are redacted in accordance with applicable laws. FDA completed posting the originally submitted applications on November 28, 2017.  The following modules are currently publicly available:

Originally Submitted Applications:

Amendments:

History of original application documents posted (most recent at the top):

We anticipate making amendments received thus far publicly available over the next several months, and amendments received in the future will be made publicly available as they are redacted. On November 21, 2017, FDA issued a notice in the Federal Register extending the comment period for the Philip Morris Products S.A. MRTP applications. As described in that notice, FDA intends to issue another notice in the Federal Register announcing when the comment period will close, which will be at least 30 days from the date the last application documents are posted. Public comments may be submitted on all available application materials throughout the comment period. 

The Table of Contents documents in Module 2 have information about all modules in the originally submitted applications. Module 9 contains full articles referenced elsewhere in the applications and will not be posted.

The Tobacco Products Scientific Advisory Committee will meet on January 24-25, 2018, to discuss these applications and provide their recommendations to FDA.  

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.

Page Last Updated: 01/23/2018
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