FDA Reviews ZYN Nicotine Pouch MRTP Applications from Swedish Match USA

The FDA Center for Tobacco Products announced it has 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, which occurred after an extensive scientific review of their premarket tobacco product applications (PMTAs). The MRTP applications, covering ZYN products in 3-milligram and 6-milligram strengths, signify a further regulatory step for these modern oral nicotine products in the U.S. market.

The applications, filed on June 17, 2025, pertain to 20 distinct ZYN nicotine pouch products. These products are described as small fiber pouches containing nicotine, designed for placement between a user's gum and lip. Prior to the MRTP filing, the FDA had already authorized the sale of these specific ZYN nicotine pouch products on January 16, 2024, as noted in materials posted on February 2, 2026, following their PMTA submissions. The current MRTP process aims to assess whether these products can be marketed with claims of reduced harm or exposure.

As part of the MRTP review process, the FDA established a public comment period for these applications on June 18, 2025, via regulations.gov under docket number FDA-2025-N-0835. This period concluded on March 4, 2026, allowing stakeholders and the public to submit feedback on the proposed modified risk claims. Additionally, 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, with the proceedings made accessible to the public via a live webcast.

The FDA's review of MRTP applications is mandated by Section 911(e) of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act. This section requires the agency to make MRTP applications publicly available, excluding trade secrets or confidential commercial information, and to solicit comments on the information presented, including proposed labels, labeling, and advertising. This regulatory framework underscores the agency's commitment to a transparent and scientifically rigorous evaluation of products seeking modified risk status, which could influence consumer perceptions and market dynamics for tobacco alternatives.