Tobacco Products

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

Tobacco Products Scientific Advisory Committee Meeting Announcement: February 6-7, 2019

FDA has announced a TPSAC meeting to discuss the modified risk tobacco product (MRTP) application submitted by U.S. Smokeless Tobacco Company for Copenhagen Snuff Fine Cut tobacco product, which is currently under scientific review by FDA. TPSAC members will also discuss scientific issues related to an amendment from Swedish Match North America, Inc. (SMNA) on their modified risk tobacco product applications for eight General Snus products. Please refer to the Federal Register notice for instructions on how to submit public comments to TPSAC.

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

Beginning on September 21, 2018, you may submit comments including data, research, and other related information to docket FDA-2018-N-3261. There is currently no deadline for public comments. Once all materials from the MRTP application, including amendments, are added, FDA will announce the closing date for the comment period, which will be both at least 180 days after posting the first application materials and at least 30 days from the date the last application materials are added.

On September 14, 2018, FDA filed for substantive scientific review 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. The Federal Register will publish a notice establishing a formal docket for public comments on regulations.gov at a later date.

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 were added on September 14, 2018.

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

Originally Submitted Application:

Amendments

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.

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.

Page Last Updated: 12/17/2018
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