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

On March 16, 2023, FDA issued a modified risk granted order authorizing U.S. Smokeless Tobacco Company to market Copenhagen Classic Snuff as a modified risk tobacco product with the claim:

"IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer."

This product, previously marketed without modified risk information as Copenhagen Snuff Fine Cut, is authorized to be on the market because it meets the definition of a pre-existing tobacco product. 

See the Modified Risk Granted Orders  webpage for the order letter, decision summary, and other documents relevant to this MRTP application.

Please sign up to receive email alerts when any MRTP application materials are made publicly available or check this webpage regularly. The latest set of application materials from U.S. Smokeless Tobacco Company were added on March 14, 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 AskCTP@fda.hhs.gov or call 1-877-287-1373.

Originally Submitted Application:

Amendments

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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