FDA Schedules Advisory Committee Meeting for ZYN Nicotine Pouch MRTP Applications

The FDA Center for Tobacco Products has announced a virtual Tobacco Products Scientific Advisory Committee (TPSAC) meeting scheduled for January 22, 2026. The meeting will discuss modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 ZYN nicotine pouch products. These products, available in 3mg and 6mg strengths, were previously authorized for marketing through the premarket tobacco product application (PMTA) pathway in January 2025, according to the FDA.

Swedish Match USA, Inc. is seeking authorization to market these ZYN nicotine pouch products with a modified risk claim. The 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.” Under federal law, an MRTP application must demonstrate 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.

By law, the FDA must refer MRTP applications to TPSAC for review. The committee's discussion will focus on evidence concerning 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 FDA has established a public docket (No. FDA-2025-N-0835) for comments on this TPSAC meeting, with the comment period closing on January 21, 2026. Comments submitted by January 7, 2026, will be provided to the Committee.

The virtual meeting will be open to the public, with opportunities for oral presentations from interested parties between approximately 1:00 p.m. and 2:00 p.m. ET on January 22, 2026. Redacted application documents related to the ZYN nicotine pouch MRTP applications are available on the FDA’s website for public review. The FDA states that it will consider all relevant information, including public comments and the recommendations from the TPSAC, before making a final determination on the MRTP applications.