FDA Initiates Review of Modified Risk Claims for ZYN Nicotine Pouches

On June 17, 2025, the U.S. Food and Drug Administration (FDA) issued a filing letter to Swedish Match USA, Inc., initiating the scientific review process for modified risk tobacco product (MRTP) applications for 20 ZYN nicotine pouch products. These products had previously been authorized for sale in January 2025 under premarket tobacco product applications (PMTAs).

Swedish Match now seeks to market these products with the claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” FDA will evaluate whether the evidence supports this modified risk claim and will either approve or deny the application.

Beginning June 18, 2025, the public can submit comments on the applications via regulations.gov under docket FDA-2025-N-0835. Application documents will be posted on the CTP website after redaction, and the public comment period will last a minimum of 180 days from the Federal Register notice.

Additionally, the FDA’s Tobacco Product Scientific Advisory Committee (TPSAC) will meet to discuss the applications, as required by the 2009 Family Smoking Prevention and Tobacco Control Act. Meeting details will be announced soon.