FDA Files Swedish Match ZYN Nicotine Pouch MRTP Applications for Review

The U.S. Food and Drug Administration (FDA) has initiated substantive scientific review of Modified Risk Tobacco Product (MRTP) applications submitted by Swedish Match USA, Inc. for its ZYN nicotine pouch products. The agency filed these applications on June 17, 2025, marking a significant step in the regulatory process for modern oral nicotine products in the North American market. This development follows the FDA's prior authorization for the sale of these ZYN products in January 2025, after an extensive review of their premarket tobacco product applications (PMTAs).

The MRTP applications cover a range of ZYN nicotine pouch products, each offered in two distinct strengths: 3 milligrams and 6 milligrams. Nicotine pouches, as described by the FDA, are small fiber pouches containing nicotine, designed for placement between a person’s gum and lip. The initial authorization in January 2025 encompassed 20 specific ZYN nicotine pouch products, allowing their continued presence in the U.S. market. The current MRTP review focuses on claims related to reduced exposure or risk.

As part of the MRTP review process, the FDA established a public comment period for these applications. This period commenced on June 18, 2025, with a closing date of March 4, 2026, for submissions to docket number FDA-2025-N-0835 on regulations.gov. 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. This meeting was accessible to the public via a live webcast, providing an avenue for transparency in the scientific review.

The FDA's engagement with public comments and advisory committees aligns with its statutory obligations. Section 911(e) of the Federal Food, Drug & Cosmetic Act, as amended by the Tobacco Control Act, mandates that the FDA make MRTP applications publicly available, excluding trade secrets or confidential commercial information. This provision also requires the agency to solicit public comments on the information contained within the applications, as well as on the proposed labels, labeling, and advertising accompanying them. This structured approach ensures a comprehensive evaluation of any modified risk claims.