U.S. FDA Posts Final ZYN MRTP Materials, Sets March 4 Deadline for Public Comments

Feb.03

U.S. FDA has released the final batch of materials for ZYN MRTP applications and set March 4 (11:59 p.m. ET) as the deadline for public comments to be considered in the agency’s review.

Key Points

On Feb. 2, 2026, FDA posted additional MRTP materials for ZYN—described as the final set.
The applications were submitted by Swedish Match USA, Inc. for 20 ZYN nicotine pouch products.
Materials are available on the Swedish Match USA, Inc. MRTP application webpage.
Public comments close March 4, 2026, at 11:59 p.m. ET.

2Firsts, Feb. 3, 2026

According to the U.S. Food and Drug Administration (FDA), the agency on Feb. 2 posted new materials related to modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 ZYN nicotine pouch products, and set March 4, 2026 (11:59 p.m. ET) as the deadline for public comments.

FDA said the documents are available on the Swedish Match USA, Inc. MRTP application webpage and described this release as the final set of application materials.

To be considered, public comments must be submitted to Docket No. FDA-2025-N-0835-0001 by the deadline.

Image source:U.S. FDA

References:

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

Also Read:

[1] U.S. FDA posts TPSAC meeting materials ahead of discussion on ZYN MRTP applications

[2] U.S. Court Rules Zyn Marketing Dispute Can Proceed, Rejects Philip Morris International’s Bid to Dismiss

[3] ZYN Nicotine Pouches Seek MRTP Authorization; FDA Sets January Meeting

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