By Timothy S. Donahue

Top Takeaways:

• Final MRTP stage: FDA posted the last set of materials for Swedish Match’s ZYN MRTP applications, moving the review into its closing phase.
• Public input deadline set: Comments must be filed to the ZYN MRTP docket by March 4, after which FDA can move toward a decision.
• High-stakes precedent: The outcome will test whether nicotine pouches can follow General Snus as an FDA-authorized reduced-risk product—and could shape the future of the U.S. pouch market.

The U.S. Food and Drug Administration on Feb. 2 posted the final set of materials related to Swedish Match USA’s modified risk tobacco product (MRTP) applications for 20 ZYN nicotine pouch products, formally moving the long-running review process into its closing phase.

The documents—now available on the agency’s Swedish Match MRTP application page—trigger the final public comment window for the applications. FDA said comments must be submitted to Docket No. FDA-2025-N-0835-0001 by 11:59 p.m. ET on March 4 to be considered.

The posting follows last month’s virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC), where FDA convened outside experts to evaluate whether Swedish Match’s proposed MRTP claims for ZYN are supported by scientific evidence and would benefit public health at the population level.

Swedish Match is seeking authorization to market certain ZYN nicotine pouches with reduced-risk claims compared to cigarettes, arguing the products significantly lower users’ exposure to harmful and potentially harmful constituents. ZYN products do not contain tobacco leaf and are smoke-free, but they do contain nicotine and are regulated as tobacco products under U.S. law.

The applications build on Swedish Match’s earlier regulatory success with General Snus, which in 2019 became the first smokeless tobacco product authorized by FDA to carry an MRTP claim. That decision is frequently cited as a precedent in the ZYN review, though FDA has repeatedly stressed that MRTP determinations are product-specific and evidence-driven.

Public health groups remain divided on the ZYN applications. Harm-reduction advocates argue that granting MRTP status to nicotine pouches could accelerate switching away from cigarettes among adult smokers, while critics warn about youth appeal, rapid category growth, and normalization of nicotine use.

FDA has not indicated when it expects to issue a final decision following the close of the comment period. Under statute, MRTP orders are time-limited and subject to ongoing post-market surveillance and reporting requirements if granted.