FDA Schedules TPSAC Meeting for ZYN Nicotine Pouch MRTP Applications

The U.S. Food and Drug Administration (FDA) Center for Tobacco Products has announced a virtual Tobacco Products Scientific Advisory Committee (TPSAC) meeting scheduled for January 22, 2026. The meeting will focus on the modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 ZYN nicotine pouch products. These products, available in 3 milligrams and 6 milligrams strengths, are seeking authorization to market with a modified risk claim.

The FDA previously authorized the marketing of these 20 ZYN nicotine pouch products in January 2025 through the premarket tobacco product application (PMTA) pathway, following an extensive scientific review. Swedish Match USA, Inc. is now pursuing an additional authorization to make a modified risk claim. The company's proposed claim states: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

An MRTP application, by law, requires demonstrating that the product, as used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual users, and benefit the health of the population as a whole. The TPSAC meeting's discussion will specifically address evidence related to the products' relative health risks, consumer understanding and perceptions of the proposed modified risk claim, and the potential public health impact of a marketing order.

The virtual TPSAC meeting will be open to the public, with opportunities for oral presentations from interested parties on January 22, 2026. The FDA has also established a public docket (No. FDA-2025-N-0835) for comments, which will close on January 21, 2026. Comments received by January 7, 2026, will be provided to the Committee for consideration. Application materials related to the ZYN MRTP applications are available on the FDA's website. The agency considers all relevant information, including public comments and TPSAC recommendations, before making a final determination on an MRTP application.