FDA Files ZYN Nicotine Pouch MRTP Applications for Scientific Review

The U.S. Food and Drug Administration (FDA) Center for Tobacco Products announced on June 17, 2025, that it filed Modified Risk Tobacco Product (MRTP) applications from Swedish Match USA, Inc. for ZYN nicotine pouch products for substantive scientific review. This development follows the FDA's authorization for sale of 20 ZYN nicotine pouch products in January 2025, after an extensive scientific review of their premarket tobacco product applications (PMTAs). The MRTP applications seek to allow the marketing of these products with claims of reduced risk.

The MRTP applications cover ZYN nicotine pouch products available in two strengths: 3 milligrams and 6 milligrams. These products are described as small fiber pouches containing nicotine, designed for placement between the gum and lip. The FDA initiated a public comment period for these MRTP applications on June 18, 2025, with the docket number FDA-2025-N-0835. This comment period concluded on March 4, 2026, at 11:59 p.m. ET, allowing public input on the submitted materials.

The filing of MRTP applications signifies a further stage in the regulatory process for ZYN nicotine pouches in the U.S. market. The FDA previously authorized the sale of these 20 ZYN nicotine pouch products under the PMTA pathway, which assesses whether a new tobacco product is appropriate for the protection of public health. The MRTP pathway, as outlined in section 911(e) of the Federal Food, Drug & Cosmetic Act, requires the FDA to make applications publicly available and solicit comments, except for trade secrets or confidential commercial information.

As part of the review process, the Tobacco Products Scientific Advisory Committee (TPSAC) convened a virtual meeting on January 22, 2026, to discuss the MRTP applications for ZYN nicotine pouch products. This meeting was open to the public via live webcast, providing a forum for expert discussion and public observation of the scientific review. The FDA continues to make application documents and amendments publicly available through its website, encouraging stakeholders to monitor updates.