# 2025-10821: FDA Asks Whether ZYN Nicotine Pouches Deserve Lower-Risk Labels

2025-10821, Modified Risk Tobacco Product Application: Applications for ZYN Products Submitted by Swedish Match U.S.A., Inc., is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-18, effective 2025-06-18; PRIA reads it as touching household money (as of 2026-11-03).

- Canonical: https://policyrisk.com/federal-register/2025-10821
- As of: 2026-11-03
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-10821
- Title: Modified Risk Tobacco Product Application: Applications for ZYN Products Submitted by Swedish Match U.S.A., Inc.
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 26053
- Published: 2025-06-18
- Effective: 2025-06-18
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-11-03

## In one line

FDA Asks Whether ZYN Nicotine Pouches Deserve Lower-Risk Labels

## Summary

The FDA is inviting the public to comment on Swedish Match U.S.A.'s applications to label their ZYN nicotine pouches as lower-risk tobacco products. This affects anyone interested in tobacco product safety and marketing, with comments open starting June 18, 2025. The decision could change how ZYN products are sold and perceived, possibly impacting the market and consumer choices.

## Abstract

The Food and Drug Administration (FDA or Agency) is announcing an opportunity to provide public comment on modified risk tobacco product applications (MRTPAs) submitted by Swedish Match U.S.A., Inc. for ZYN oral pouch products containing nicotine derived from tobacco.

## Effects PRIA read

- Public comment opens for ZYN MRTPAs: benefit, low. You can submit electronic or written comments on Swedish Match U.S.A.'s modified risk tobacco product applications for ZYN starting June 18, 2025. FDA will post redacted application documents on its website and on regulations.gov, and will set a closing date that is at least 180 days after this not…
- Specific ZYN flavors/strengths under review: mixed, medium. FDA has filed MRTP applications from Swedish Match U.S.A. for specific ZYN oral pouch products, including multiple flavors (Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth/Original, Chill/Classic, Menthol/Fresh) at 3 mg and 6 mg nicotine strengths. The company is see…

## Related documents

- [2026-20848](https://policyrisk.com/federal-register/2026-20848): Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods, 2026-10-13
- [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11
- [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13
- [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29
- [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25
- [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27

## Sources
- [2025-10821 on federalregister.gov](https://www.federalregister.gov/documents/2025/06/18/2025-10821/modified-risk-tobacco-product-application-applications-for-zyn-products-submitted-by-swedish-match)
- [2025-10821 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-10821.pdf)

## Related
- [Previous: 2025-11170, NTIA Listening Session on Bolstering Data Center Growth, Resilience and Security](https://policyrisk.com/federal-register/2025-11170)
- [Next: 2025-10985, Privacy Act of 1974; Matching Program](https://policyrisk.com/federal-register/2025-10985)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-10821 (as of 2026-11-03).
