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Swedish Match USA, Inc. Modified Risk Tobacco Product (MRTP) Applications for ZYN Products

On June 30, 2026, FDA issued modified risk granted orders to Swedish Match USA, Inc. for 20 ZYN nicotine pouch products. With this issuance, these ZYN nicotine pouch products may be marketed with the following modified risk claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”  

The products receiving modified risk granted orders include the following, each with two nicotine strengths (3 milligram and 6 milligram):

  • ZYN Chill
  • ZYN Cinnamon
  • ZYN Citrus
  • ZYN Coffee
  • ZYN Cool Mint

  • ZYN Menthol
  • ZYN Peppermint
  • ZYN Smooth
  • ZYN Spearmint
  • ZYN Wintergreen

See the Modified Risk Granted Orders webpage for order letters and decision summaries relevant to these actions.

The tobacco products in the applications are commonly referred to as nicotine pouches, which are small fiber pouches containing nicotine designed to be placed between a person’s gum and lip. Following a thorough review, FDA originally authorized the marketing of these products without modified risk claims through the premarket tobacco product application (PMTA) pathway on January 16, 2025.

Comment on Swedish Match USA, Inc., MRTP Applications for ZYN Nicotine Pouch Products

On June 18, 2025, FDA established a docket for public comments on these MRTP applications on regulations.gov (docket number FDA-2025-N-0835). The comment period for this docket closed at 11:59 p.m. ET on March 4, 2026.

View the Materials and Related Documents section of this webpage for up-to-date publicly available application documents and amendments.

Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted or check this webpage regularly. The latest set of application materials from Swedish Match USA, Inc. were made available on February 2, 2026.

Tobacco Products Scientific Advisory Committee Meeting

On January 22, 2026, the Tobacco Products Scientific Advisory Committee (TPSAC) held a virtual meeting to discuss the MRTP applications for ZYN nicotine pouch products. 

The meeting was open to the public via live webcast. Visit the TPSAC meeting event page to learn more.

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.

The latest set of application materials include:

Swedish Match MRTP Applications for ZYN Nicotine Pouch Products

Cross-Referenced Submissions

Previously Reviewed Application(s) for ZYN

Note: 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 labels, labeling, and advertising accompanying the applications.

Additional Resources

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