Tobacco Products

Swedish Match North America, Inc., MRTP Applications

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

FDA has announced a TPSAC meeting to 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. TPSAC members will also 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. Please refer to the Federal Register notice for instructions on how to submit public comments to TPSAC.

Submit comments on Swedish Match North America, 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 North America, Inc. has been reopened to accept comments on posted amendments. There is currently no deadline for public comments. Once all materials from these MRTP applications, including amendments, are posted, FDA will announce the closing date for the comment period, which will be at least 30 days from the date the last application materials are posted.

On December 14, 2016, the FDA denied one request contained in modified risk tobacco product applications submitted by 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 January 16, 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.

Persons with disabilities having problems accessing these files may call 1-877-CTP-1373 for assistance.

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: 01/16/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English