ZYN Nicotine Pouches Seek MRTP Authorization; FDA Sets January Meeting

Key Points

• TPSAC will review MRTP applications for 20 ZYN nicotine pouch products.
• Company proposes the claim:“Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
• FDA has begun substantive scientific review; applications are open for public comment.
• MRTP authorization requires evidence of reduced individual harm and population-level benefit.
• Public comments accepted via Docket No. FDA-2025-N-0835 until January 21, 2026.
• Requests to provide oral comments must be submitted by December 31, 2025.
• Meeting will be virtual and publicly accessible.

2Firsts, November 24, 2025 — According to the U.S. Food and Drug Administration (FDA), a virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) will be held on January 22, 2026, to evaluate the Modified Risk Tobacco Product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 ZYN nicotine pouch products.

The MRTP review covers 10 flavors in two strengths (3 mg and 6 mg):

ZYN Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen.

These products received PMTA authorization in January 2025, but marketing them with reduced-risk claims requires separate MRTP approval.

The proposed claim is:

“Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

FDA notes that MRTP applications must demonstrate reduced harm under actual use conditions and show a net population health benefit.

By law, MRTP applications must undergo TPSAC review. The committee will evaluate:

• Relative health risk evidence
• Consumer understanding of the proposed claim
• Potential public health impact of a modified risk order

The session will be virtual and open to the public with captioning and recording available.

Public comments may be submitted to Docket No. FDA-2025-N-0835 until 11:59 p.m. ET on January 21, 2026.

Comments submitted by January 7 will be forwarded to the committee.

Individuals wishing to provide oral comments must apply by 12 p.m. ET on December 31, 2025, with a summary of their intended remarks and participant information.

FDA also published redacted application materials for public review. Final MRTP determinations will incorporate all scientific evidence, public comments, and TPSAC recommendations.

Image source: FDA