Tobacco Products

R.J. Reynolds Tobacco Company Modified Risk Tobacco Product (MRTP) Applications

To Comment on the R.J. Reynolds Tobacco Company MRTP Applications

Submit comments including data, research, and other related information to docket FDA-2017-N-4678-0001. There is currently no deadline for public comments. There may be conflicting deadlines added on and While we cannot control how information is displayed on those websites, the docket will remain open beyond any currently added, specific closing dates.

On May 9, 2018, FDA extended the comment period for the R.J. Reynolds Tobacco Company MRTP applications. Once all materials from these MRTP applications, including amendments, are added, FDA will announce the closing date for the comment period, which will be at least 30 days from the date the last application materials are added.  

On December 18, 2017, FDA filed for substantive scientific review six Modified Risk Tobacco Product (MRTP) Applications from R.J. Reynolds Tobacco Company for the following smokeless tobacco products:

  • Camel Snus Frost
  • Camel Snus Frost Large
  • Camel Snus Mellow
  • Camel Snus Mint
  • Camel Snus Robust
  • Camel Snus Winterchill

Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been added or check this webpage regularly. The most recently added application materials were made available on September 6, 2018.

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

Originally Submitted Applications:

  • Module 7: Scientific Studies and Analyses — added May 9, 2018; updated August 17, 2018

7.1: Chemistry (zip – 72 MB) – added August 17, 2018

7.2: In Vitro – not yet available

7.6: Modeling (zip – 14 MB) – added May 9, 2018

7.7: Other (zip – 172 MB) – added May 9, 2018 

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.

The Tobacco Products Scientific Advisory Committee will meet on September 13-14, 2018, to discuss these applications and provide their recommendations to the FDA. More information is on the 2018 TPSAC meeting webpage.

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 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: 09/07/2018
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