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. There is currently no deadline for public comments. 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 beyond any currently posted, specific closing dates.

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. 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.

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 most recently posted materials were made available on December 17, 2018.

The following modules are currently publicly available:

Originally Submitted Applications:

Amendments:

March 16, 2017 Amendment: Response to March 2, 2017, FDA Advice and Information Request Letter (.zip – 56 MB) (originally added January 12, 2018)
FDA has also posted this amendment in 10 separate parts below.

 

May 15, 2017 Amendment: Re-submission of Data Previously Provided in the March 16, 2017, Amendment with Additional Study Reports and Data (.zip – 32 GB) (added February 23, 2018)
*This ZIP file includes several individual files. Depending on your internet connection speed and other factors, it may take a few minutes or up to several hours to download the ZIP file completely. FDA has also posted this amendment in 20 separate parts below:  

 

August 30, 2018 Amendment: Submission of Finalized In Vivo Study (.zip – 900 KB) (originally added November 26, 2018). FDA has also posted this amendment in seven separate parts below. 

  • Part 1 of 7 (.zip - 491.5 MB) (posted December 17, 2018)
  • Part 2 of 7 (.zip - 794.6 MB) (posted December 17, 2018)
  • Part 3 of 7 (.zip - 28.7 MB) (posted December 17, 2018)
  • Part 4 of 7 (.zip - 16.8 MB) (posted December 17, 2018)
  • Part 5 of 7 (.zip - 25.6 MB) (posted December 17, 2018)
  • Part 6 of 7 (.zip - 8.4 MB) (posted December 17, 2018)
  • Part 7 of 7 (.zip - 3.7 MB) (posted December 17, 2018)  

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.

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: 12/17/2018
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