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. The comment period for this docket will close 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.

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 — 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
- Module 4: Nonclinical (zip – 149KB) – posted November 21, 2025
- Module 5: Clinical Individual Health Studies (zip – 127MB) – posted November 21, 2025
- Module 6: Clinical Population Health Studies (zip – 6MB) – posted November 21, 2025
- Module 7: Environmental Assessment (zip – 16MB) – posted November 21, 2025
Amendment: August 16, 2024, Cross-reference to biomarker study added to a Tobacco Product Master File (zip – 783KB) – posted February 2, 2026

Cross-Referenced Submissions

Swedish Match USA, Inc. Applications for General Snus products
- Swedish Match USA, Inc. MRTPAs for General Snus
- Swedish Match USA, Inc. MRTP Renewal Applications for General Snus
- Swedish Match USA, Inc. Annual Reports for General Snus

Previously Reviewed Application(s) for ZYN

January 16, 2025 - Received Marketing Granted Order
- FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review

PMTAs for Swedish Match ZYN Nicotine Pouch Products (Authorized January 16, 2024) – posted February 2, 2026

Section A General Information (zip – 4MB) – posted February 2, 2026
Section B Table of Contents (zip – 743KB) – posted February 2, 2026
Section C Descriptive Product Info (zip – 805KB) – posted February 2, 2026
Section D Product Samples (zip – 134KB) – posted February 2, 2026
Section E Product Packaging-Labeling (zip – 5MB) – posted February 2, 2026
Section F Product Environ Assessment (zip – 2MB) – posted February 2, 2026
Section G Summary-Research Findings (zip – 39MB) – posted February 2, 2026
Section H Scientific Studies-Analyses Part 1 (zip – 91MB) – posted February 2, 2026
Section H Scientific Studies-Analyses Part 2 (zip – 130MB) – posted February 2, 2026
Section I References Part 1 (zip – 128MB) – posted February 2, 2026
Section I References Part 2 (zip – 92MB) – posted February 2, 2026
Section I References Part 3 (zip – 173MB) – posted February 2, 2026
Section I References Part 4 (zip – 174MB) – posted February 2, 2026
Section I References Part 5 (zip – 88MB) – posted February 2, 2026
Section I References Part 6 (zip – 70MB) – posted February 2, 2026
Section I References Part 7 (zip – 41MB) – posted February 2, 2026
Section I References Part 8 (zip – 176MB) – posted February 2, 2026

Amendments
- August 3, 2020, Response to July 24, 2020 Deficiency Letter (zip – 479KB) – posted February 2, 2026
- September 24, 2020, Response to July 24, 2020 Deficiency Letter (zip – 105MB) – posted February 2, 2026
- March 7, 2022, Response to July 24, 2020 Deficiency Letter regarding use of "tobacco-free" phrase (zip – 5MB) – posted February 2, 2026
- October 12, 2023, Updates to scientific content and cross-referenced Tobacco Product Master File (zip – 4MB) – posted February 2, 2026
- December 21, 2023, Updates to the literature search and labeling and marketing sections of the PMTA (zip – 6MB) – posted February 2, 2026

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.