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

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 latest set of application materials from R.J. Reynolds Tobacco Company were added on March 5, 2019.

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 March 5, 2019

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

  • M194A-GLP (AMES) – Determination of Mutagenic Response of Camel Snus and Other Tobacco Products 
    • 01_M194A (zip – 149 MB) (added March 5, 2019)
  • M914B-GLP (NRU) – Determination of Cytotoxic Response of Camel Snus and Other Tobacco Products 
    • 02_M194B (zip – 297 MB) (added March 5, 2019)
  • M125 (SCE) – Toxicology of Tobacco Products – Sister Chromatid Exchange Genotoxicity 
  • M100 (NRU) – Toxicology of Smokeless Tobacco Products – Neutral Red Cytotoxicity 
  • M100 (MN) – Toxicology of Smokeless Tobacco Products – In Vitro Micronucleus Assay 
  • M97 (AMES) – Toxicology of Smokeless Tobacco Products – Bacterial Reverse Mutagenicity 

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

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

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.


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