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                        Modified Risk Tobacco Products Home
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          Swedish Match USA, Inc., MRTP ApplicationsAdvertising and Promotion Swedish Match USA, Inc., MRTP Applications
  
  	
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    PrintOn October 22, 2019, the FDA issued modified risk orders to 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 LargeOn November 30, 2023, FDA filed for scientific review modified risk tobacco product (MRTP) application renewals submitted by Swedish Match USA for the General Snus products. The original MRTP orders are valid for a term of 5 years from the date of issuance. To continue marketing an MRTP after the term of an order, the company may submit an MRTP renewal application for FDA to determine that the product still satisfies the requirements in section 911. Renewal applications may cross-reference an applicant’s original MRTP as well as postmarket annual reports submitted in accordance with marketing order requirements for both the premarket tobacco application (PMTA) and MRTP. Annual reports for MRTPs contain the cumulative results from the postmarket surveillance and studies that all companies are required to conduct as part of a modified risk granted order.

Once all materials from these MRTP renewal applications are posted, 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 posted.

See theModified Risk Orders webpage for order letters and decision summaries relevant to these actions.

Please sign up to receive email alertswhen materials from any MRTP applications under scientific review have been posted. The latest set of application materials from Swedish Match USA, Inc. were made available on **November 30, 2023**.

Materials and Related Documents

***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.*

Additional materials related to the actions include:

**Swedish Match USA, Inc. MRTP Application Renewal – posted November 30, 2023**

Swedish Match USA, Inc. MRTP Renewal Applications  (zip* – 7.3 MB) – posted November 30, 2023 

	FDA will post application documents, including amendments, on a rolling basis as the documents are redacted.
		Cross-referenced submissions to support the application are listed below.
	Original PMTA and Amendments (Authorized November 10, 2015) – posted November 30, 2023 (zip – 62 MB)2016 PMTA Annual Reports posted November 30, 2023
	2016 Annual Reports Part 1 (zip – 31.87 MB)
	2016 Annual Reports Part 2(zip – 57.02 MB)
	2016 Annual Reports Part 3 (zip – 57.66 MB)
	2016 Annual Reports Part 4 (zip – 56.92 MB)
	2016 Annual Reports Part 5(zip – 57.21 MB)
	2016 Annual Reports Part 6 (zip – 55.10 MB)
	2016 Annual Reports Part 7 (zip – 57.10 MB)
	2016 Annual Reports Part 8 (zip – 4.77 MB)
	2016 Annual Reports Part 9 (zip – 5.04 MB)

2017 PMTA Annual Reports posted November 30, 2023
	2017 Annual Reports Part 1 (zip – 12.93 MB)
	2017 Annual Reports Part 2(zip – 12.62 MB)
	2017 Annual Reports Part 3 (zip – 13.08 MB)
	2017 Annual Reports Part 4 (zip – 2.85 MB)
	2017 Annual Reports Part 5 (zip – 12.83 MB)
	2017 Annual Reports Part 6 (zip – 2.65 MB)
	2017 Annual Reports Part 7 (zip – 43.64 MB)
	2017 Annual Reports Part 8 (zip – 11.26 MB)
	2017 Annual Reports Part 9 (zip – .001 MB)

2020 PMTA and MRTP Annual Reports posted November 30, 2023
	2020 Annual Reports Part 1 (zip – 10.13 MB)
	2020 Annual Reports Part 2 (zip – 29.13 MB)
	2020 Annual Reports Part 3 (zip – 1.89 MB)
	2020 Annual Reports Part 4 (zip – 1.85 MB)
	2020 Annual Reports Part 5 (zip – 9.70 MB)
	2020 Annual Reports Part 6 (zip – 10.12 MB)
	2020 Annual Reports Part 7 (zip – 28.55 MB)
	2020 Annual Reports Part 8 (zip – 28.55 MB)
	2020 Annual Reports Part 9 (zip – 9.70 MB)
	2020 Annual Reports Part 10 (zip – 2.00 MB)
	2020 Annual Reports Part 11 (zip – .75 MB)
	2020 Annual Reports Part 12 (zip – .62 MB)

2021 PMTA and MRTP Annual Reports posted November 30, 2023
	2021 Annual Reports Part 1 (zip – 1.49 MB)
	2021 Annual Reports Part 2 (zip – 90.18 MB)
	2021 Annual Reports Part 3 (zip – 18.01 MB)
	2021 Annual Reports Part 4 (zip – 18.01 MB)
	2021 Annual Reports Part 5 (zip – 38.76 MB)
	2021 Annual Reports Part 6 (zip – 66.54 MB)
	2021 Annual Reports Part 7 (zip – 43.84 MB)
	2021 Annual Reports Part 8 (zip – 84.19 MB)
	2021 Annual Reports Part 9 (zip – 1.50 MB)
	2021 Annual Reports Part 10 (zip – 1.50 MB)
	2021 Annual Reports Part 11 (zip – 23.11 MB)
	2021 Annual Reports Part 12 (zip – 17.19 MB)
	2021 Annual Reports Part 13 (zip – 1.49 MB)

2022 PMTA and MRTP Annual Reports posted November 30, 2023
	2022 Annual Reports Part 1 (zip – 4.36 MB)
	2022 Annual Reports Part 2 (zip – 15.37 MB)
	2022 Annual Reports Part 3 (zip – 12.22 MB)
	2022 Annual Reports Part 4 (zip – .03 MB)
	2022 Annual Reports Part 5 (zip – 6.11 MB)
	2022 Annual Reports Part 6 (zip – 59.34 MB)
	2022 Annual Reports Part 7 (zip – 575.38 MB)
	2022 Annual Reports Part 8 (zip – .06 MB)
	2022 Annual Reports Part 9 (zip – .06 MB)

**Swedish Match USA, Inc. MRTP Application – Authorized on Oct. 22, 2019**

FDA Decision Summary(PDF – 5 MB) – posted December 14, 2016

	FDA Response Letter (PDF – 65 KB) – posted December 14, 2016
		FDA Denial Letters (.zip – 282 KB) – posted December 14, 2016
	Summary of Applications (PDF – 32 MB) (posted August 27, 2014; updated January 16, 2019)
	FDA initially redacted certain harmful and potentially harmful constituents (HPHC) information on pp. 517-544 (internal document pagination), which were later made publicly available. The current version reflects the removal of these redactions.
	Swedish Match North America, Inc. MRTP Applications  (zip*, 813 files, 1.7 GB) – posted August 27, 2014
	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 the Applications
	Amendments to Swedish Match North America, Inc. MRTP Applications Received After Filing, (.zip – 1.14 GB) posted July 31, 2015
		September 17, 2018 Amendment: Response to FDA's December 14, 2016 Letter (.zip 65 MB) posted October 10, 2018
		November 28, 2018 Amendment: Response to October 24, 2018, FDA Advice and Information Request Letter (.zip – 114 MB) posted December 17, 2018
		January 30, 2019 Amendment: Amended Response to October 24, 2018, FDA Advice and Information Request Letter (.zip – 5 MB) posted February 1, 2019** 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.*

***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.*

Additional Resources

FDA Authorizes Modified Risk Tobacco Products
	October 22, 2019 – FDA grants first-ever modified risk orders to eight smokeless tobacco products
	Tobacco Products Scientific Advisory Committee: February 2019 Meeting Materials
	December 14, 2016 - FDA takes action on applications seeking to market modified risk tobacco products
	Perspective: Lessons Learned from the First Review of Modified Risk Tobacco Product (MRTP) Applications
	November 10, 2015 - FDA issues first product marketing orders through premarket tobacco application pathway
	Tobacco Product Scientific Advisory Committee (TPSAC) – April 2015 Meeting Materials
	TPSAC Meetings on MRTP Applications
	MRTP Overview

                                                                                  Content current as of:
      11/30/2023
              
              
Regulated Product(s)
		 TobaccoAdvertising and Promotion

          
                        Modified Risk Tobacco Products
 
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