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          U.S. Smokeless Tobacco Company Modified Risk Tobacco Product (MRTP) ApplicationAdvertising and Promotion U.S. Smokeless Tobacco Company Modified Risk Tobacco Product (MRTP) Application
  
  	
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    PrintOn March 16, 2023, FDA issued a modified risk granted order authorizing U.S. Smokeless Tobacco Company to market Copenhagen Classic Snuff as a modified risk tobacco product with the claim:

"IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer."

This product, previously marketed without modified risk information as Copenhagen Snuff Fine Cut, is authorized to be on the market because it meets the definition of a pre-existing tobacco product.

See the Modified Risk Granted Orders  webpage for the order letter, decision summary, and other documents relevant to this MRTP application.

Please sign up to receive email alerts when any MRTP application materials are made publicly available or check this webpage regularly. The latest set of application materials from U.S. Smokeless Tobacco Company were added on **March 14, 2022**.

The application materials below have been redacted in accordance with applicable laws.

***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.*

Originally Submitted Application:

FOIA Cover Letter (PDF – 45 KB) – (added September 14, 2018)
	Executive Summary (PDF – 1.6 MB) – (added September 14, 2018)
	Module 1: Cover Letter (PDF – 1.2 MB) – (added September 14, 2018)
	Module 2: Table of Contents, Glossary, Summary & References (zip – 2.7 MB) – (added September 14, 2018)
	Module 3: Descriptive Information (zip – 11.1 MB) – (added September 14, 2018)
	Module 4: Labels, Labeling and Advertising (zip – 10.4 MB) – (added September 14, 2018)
	Module 5: Environmental Assessments (zip – 40.4 MB) – (added September 14, 2018)
	Module 6: Summary of All Research Findings – (added September 14, 2018)
	6.0: Summary of All Research Findings (PDF – 62 KB) – (added September 14, 2018)
		6.1: Health Risks of the Tobacco Product (PDF – 993 KB) – (added September 14, 2018)
		6.2: Effect of Marketing on Consumer Understanding and Perceptions (PDF – 807 KB) – (added September 14, 2018)
		6.3: Effect of the Product on Tobacco Use Behavior Among Current Tobacco Users (PDF – 522 KB) – (added September 14, 2018)
		6.4: Effect on Tobacco Use Initiation Among Nonusers (PDF – 477 KB) – (added September 14, 2018)
		Related Files – (added September 14, 2018)
		Appendix 6.4-1: ALCS Analyses of PATH Data for Section 6.4 (PDF – 686 KB) – (added September 14, 2018)
			Appendix 6.4-2: ALCS Analyses of NSDUH Data for Section 6.4 (PDF – 512 KB) – (added September 14, 2018)
		6.5: Population Model Research Summary (PDF – 368 KB) – (added September 14, 2018)
	Module 7: Scientific Studies and Analyses – (added September 14, 2018)
	7.1: Product Analysis – Harmful Constituents (zip - 5.7 MB) – (added September 14, 2018)
		7.2: Product Analysis – Stability (zip - 18.5 MB) – (added September 14, 2018)
		7.3: Human Studies (zip - 698 MB) – (added September 14, 2018)
		7.4: Secondary Data Analyses and Models (zip - 5.2 MB) – (added September 14, 2018)
		7.5: Summary of Literature (zip - 9.1 MB) – (added September 14, 2018)
	Module 8: Post-market Assessment Plan (PDF – 90 KB) – (added September 14, 2018)**Amendments**

April 10, 2018 Amendment: Submission of Updated Appendix 7.3.3-15 Claim Comprehension and Intentions (CCI) Study SSAP Syntax Code (.zip - 814 KB) –  (added September 14, 2018)
	July 11, 2018 Amendment: Submission of a Tabulated Index for Published Literature within the Application (.zip - 1.4 MB) – (added September 14, 2018)
	July 18, 2018 Amendment: Submission of Updated Table 7.1-17: Summary of Individual Lot Results – Constituents (Dry Weight Basis) (.zip - 1.4 MB) – (added September 14, 2018)
	August 8, 2018 Amendment: Response to July 10, 2018 FDA Advice and Information Request Letter (.zip - 887 MB) – (added February 4, 2019)
	August 27, 2018 Amendment: Response to August 23, 2018, FDA Information Request (.zip - 1.0 GB) – (added January 31, 2019)
	February 1, 2019 Amendment: Clarification of Product Information (.zip - 9 MB) – (added February 19, 2019)
	April 8, 2021 Amendment: Response to March 26, 2021 FDA Deficiency Letter (564 KB) – (added **March 14, 2022**)
	September 29, 2021 Amendment: Response to March 26, 2021 FDA Deficiency Letter (41 MB) – (added**March 14, 2022**)
	March 9, 2022 Amendment:  Response to March 7, 2022 FDA Request for Information (284 KB) – (added **March 14, 2022**)***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.*

                                                                                  Content current as of:
      03/16/2023
              
              
Regulated Product(s)
		 TobaccoAdvertising and Promotion

          
                        Modified Risk Tobacco Products
 
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