Tobacco Products

Swedish Match USA, Inc., MRTP Applications

Submit comments on Swedish Match USA, Inc., MRTP application amendments.

The formal docket for public comments on modified risk tobacco product (MRTP) applications for General Snus products submitted by Swedish Match USA, Inc. has been reopened to accept comments on posted amendments through May 13, 2019. 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 through May 13, 2019.

On December 14, 2016, the FDA denied one request contained in modified risk tobacco product applications submitted by Swedish Match USA, Inc. (previously known as Swedish Match North America, Inc.), for the following snus smokeless tobacco products:

  • General Loose
  • General Dry Mint Portion Original Mini
  • General Portion Original Large
  • General Classic Blend Portion White Large-12ct
  • General Mint Portion White Large
  • General Nordic Mint Portion White Large-12ct
  • General Portion White Large
  • General Wintergreen Portion White Large

The FDA also deferred final action on two other requests contained in the applications, instead issuing a response with advice on how the company may consider amending their applications to better align with existing evidence.

Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted. The most recently added application materials were made available on February 1, 2019.

General Snus MRTP Application Documents

The denial letters, response letter, and action summary (posted on December 14, 2016) are available on our website.

Additional materials related to the actions include:

* These ZIP files include several individual files. Depending on your Internet connection speed and other factors, it may take a few minutes or up to several hours to download a ZIP file completely.

Public comments may be submitted on all available application materials throughout the comment period, which will close on May 13, 2019.

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: We are required by section 911(e) of the Federal Food Drug & Cosmetic Act, as amended by the Tobacco Control Act, to make modified risk tobacco product (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. Please visit our Modified Risk Tobacco Products web page for more information.

Page Last Updated: 04/12/2019
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