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. The denial letters, response letter, and action summary are available on our website.
Additional materials related to the actions include:
- Tobacco Product Scientific Advisory Committee (TPSAC) – April 2015 Meeting Materials
- Comments Received via Regulations.gov Docket FDA-2014-N-1051
- Summary of Applications (PDF, 848 pages, 50.7 MB)
- Swedish Match North America, Inc. MRTP Applications (originally filed), August 27, 2014 (ZIP*, 813 files, 1.7 GB)
We have numbered the files to help you navigate through the materials in a logical order. For example, start with "01 application narrative summary_Redacted.pdf," proceed to "02 appendix-2a-iom-2012_Redacted.pdf," etc.
- Amendments to Swedish Match North America, Inc. MRTP Applications Received After Filing, July 31, 2015 (ZIP*, 84 files, 1.14 GB)
In addition, Scientific Reviews by Discipline and Categorical Exclusion (CatEx) will be available at a later date.
* 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.