• Feb 02, 2026
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FDA Releases Final Materials for ZYN MRTP Application, Sets March 4 Deadline for Public Comments

The U.S. Food and Drug Administration (FDA) has released the final batch of materials related to the Modified Risk Tobacco Product (MRTP) application submitted by Swedish Match USA, Inc. for its ZYN nicotine pouch products. The agency has also set March 4, 2026, at 11:59 p.m. Eastern Time as the deadline for public comments.

Key Takeaways

  • Final Materials Released: On February 2, the FDA published additional materials related to the ZYN MRTP application, stating that this update represents the final set of documents for the application.
  • Applicant: Swedish Match USA, Inc.
  • Products Covered: 20 ZYN nicotine pouch products.
  • Document Access: Materials are available on the Swedish Match USA, Inc. MRTP application webpage.
  • Public Comment Deadline: March 4, 2026, at 11:59 p.m. Eastern Time.

According to the FDA, the newly released materials were published on February 2 and relate to the MRTP application submitted by Swedish Match USA, Inc. covering 20 ZYN nicotine pouch products. The agency noted that this update constitutes the final group of materials for this MRTP application.

The FDA stated that all related documents have been made publicly available on the Swedish Match USA, Inc. MRTP application webpage to support transparency and inform the agency’s scientific review process.

The agency also emphasized that members of the public who wish to have their comments considered as part of the review must submit them before the deadline. Comments should be submitted to the designated docket to be included in the administrative record.

Public comments must be submitted by March 4, 2026, at 11:59 p.m. Eastern Time, to docket number FDA-2025-N-0835-0001.

Source: 2Firsts, February 3, 2026
Image credit: FDA