Swedish Match USA, Inc. Modified Risk Tobacco Product (MRTP) Applications for ZYN Products
On June 17, 2025, FDA filed for substantive scientific review modified risk tobacco product (MRTP) applications from Swedish Match USA, Inc. for the following ZYN nicotine pouch products, each available in two strengths (3 milligrams and 6 milligrams):
- ZYN Chill
- ZYN Cinnamon
- ZYN Citrus
- ZYN Coffee
- ZYN Cool Mint
- ZYN Menthol
- ZYN Peppermint
- ZYN Smooth
- ZYN Spearmint
- ZYN Wintergreen
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 an extensive scientific review of the premarket tobacco product applications (PMTAs) for these 20 ZYN nicotine pouch products, the FDA authorized them for sale in January 2025.
Comment on Swedish Match USA, Inc., MRTP Applications for ZYN Nicotine Pouch Products
Starting June 18, 2025, the public may submit public comments on these MRTP applications on regulations.gov to docket number FDA-2025-N-0835. There is currently no deadline for public comments.
FDA will post application documents, including amendments, on a rolling basis, as documents will need to be redacted for any confidential information. Once all materials for these MRTP applications have been made publicly available, FDA will announce a closing date for the comment period. The closing date will be no earlier than 180 days from the date of the Federal Register notice and at least 30 days from the date FDA posts the last application materials.
Please sign up to receive email alerts when materials from any MRTP applications under scientific review have been posted or check this webpage regularly.
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 — Posted June 17, 2025
- Swedish Match USA, Inc. – MRTP Applications for ZYN Nicotine Pouch Products
- Module 1: Administrative (zip – 15MB) – posted June 17, 2025
- Module 2: Summary (zip – 2MB) – posted June 17, 2025
- Module 3: Product Description and Manufacturing (zip – 111KB) – posted June 17, 2025
- FDA will post application documents, including amendments, on a rolling basis as the documents are redacted.
Note: FDA is required by section 911(e) of the Federal Food Drug & Cosmet1ic 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
- Public Docket for Swedish Match USA, Inc. MRTP Applications for ZYN Nicotine Pouch Products
- FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review
- Perspective: Lessons Learned from the First Review of Modified Risk Tobacco Product (MRTP) Applications
- TPSAC Meetings on MRTP Applications
- MRTP Overview