U.S. flag An official website of the United States government
  1. Home
  2. Tobacco Products
  3. Products, Guidance & Regulations
  4. Advertising and Promotion
  5. R.J. Reynolds Tobacco Company Modified Risk Tobacco Product (MRTP) Applications
  1. Advertising and Promotion

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

On Dec. 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

On Oct. 25, 2022, R.J. Reynolds Tobacco Company requested to withdraw these applications from FDA review. Withdrawal of an MRTP application does not prevent a company from submitting a new MRTP application for the tobacco products in the future. For any additional questions, please contact the company.

MATERIALS


The latest update to the status of this MRTP application is from Dec. 1, 2022.

The application materials below have been redacted in accordance with applicable laws.

Temporary Compliance Waiver: 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 [email protected] or call 1-877-287-1373.

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 

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.


Additional Resources

Back to Top