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U.S. Smokeless Tobacco Company Modified Risk Tobacco Product (MRTP) Application

To Comment on the U.S. Smokeless Tobacco Company MRTP Application 

You may submit comments including data, research, and other related information to docket FDA-2018-N-3261 through January 21, 2020. 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 until January 21, 2020.

On September 14, 2018, FDA filed for substantive scientific review of one Modified Risk Tobacco Product (MRTP) Application from U.S. Smokeless Tobacco Company for its Copenhagen Snuff Fine Cut, a moist snuff smokeless tobacco product. Copenhagen Snuff Fine cut is a grandfathered tobacco product, and, therefore, it is not subject to the requirement for premarket review under section 910 of the FD&C Act.  Copenhagen Snuff Fine Cut, without modified risk information, is currently available to U.S. tobacco consumers. 

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 U.S. Smokeless Tobacco Company were added on February 19, 2019.

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

Originally Submitted Application:

Amendments

Public comments may be submitted on all available application materials throughout the comment period, which will close on January 21, 2020.

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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