Advisory Committee Meeting Scheduled on Modified Risk Tobacco Product Applications for ZYN Nicotine Pouch Products
FDA has issued a Federal Register notice (FRN) announcing a virtual Tobacco Products Scientific Advisory Committee (TPSAC) meeting on January 22, 2026, to discuss the modified risk tobacco product (MRTP) applications from Swedish Match USA, Inc. for the following ZYN nicotine pouch products, each available in two strengths (3 milligrams and 6 milligrams):
- ZYN Chill
- ZYN Cinnamon
- ZYN Citrus
- ZYN Coffee
- ZYN Cool Mint
- ZYN Menthol
- ZYN Peppermint
- ZYN Smooth
- ZYN Spearmint
- ZYN Wintergreen
In January 2025, FDA authorized the marketing of these 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review.
The manufacturer is seeking to market the 20 ZYN nicotine pouch products with a modified risk claim, which requires by law an additional authorization from the FDA. Earlier this year, FDA filed the ZYN MRTP applications for substantive scientific review, and they are available for public comment. The company is proposing to use the following claim: “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 generally must demonstrate that the product, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.
By law, FDA must refer MRTP applications to TPSAC. The TPSAC meeting’s discussion will focus on evidence related to the relative health risks of the products, consumer understanding and perceptions of the applicant’s proposed modified risk claim, and the potential public health impact of a modified risk marketing order.
The TPSAC meeting will be virtual and open to the public. The meeting will be captioned and recorded. Please visit the event page to learn more about attending online.
FDA has established a docket for public comment on this TPSAC meeting. To access the docket, visit Regulations.gov and insert the Docket No. FDA-2025-N-0835. The comment period for this docket will close at 11:59 p.m. ET on January 21, 2026. Comments received on or before January 7, 2026, will be provided to the Committee. Comments received after that date will be taken into consideration by FDA but will not be considered by the Committee.
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. ET on January 22, 2026. Those interested in making oral presentations should notify the contact person and submit a brief statement describing the general nature of the evidence or arguments they wish to present, the names, phone numbers, and email addresses of proposed participants, on or before 12 p.m. ET on December 31, 2025. Review the FRN for more information.
Additionally, FDA posted application documents related to the MRTP applications for ZYN nicotine pouch products. The application materials, redacted in accordance with applicable laws and regulations, can be found on FDA’s website. FDA must make MRTP applications available for comment and reminds the public that comments directed to the applications may continue to be submitted to Docket No. FDA-2025-N-0835, established on June 18, 2025. Before making a final determination on an MRTP application, FDA takes into consideration all relevant information available to the agency, including public comments and recommendations from the TPSAC.