Philip Morris International (PMI) has submitted scientific evidence to the US Food and Drug Administration (FDA) as part of its review of a Modified Risk Tobacco Product (MRTP) designation for ZYN nicotine pouches, Tobacco Journal reports. PMI says the designation would allow its US business to inform adult smokers (21+) that switching completely from cigarettes to ZYN reduces the risk of several smoking-related diseases. The company is now awaiting an FDA decision.

On 22 January, the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) reviewed Swedish Match USA Inc.’s application to use 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.” During the meeting, the FDA noted that the evidence “suggests the proposed modified risk claim is scientifically accurate” and added that youth use of nicotine pouches remains low, while young adults exposed to the claim showed no increased intention to use ZYN.

Data presented showed that adult smokers understood the health benefits of switching completely to ZYN, while also recognizing that the product is not risk-free. Evidence indicated ZYN contains substantially lower levels of harmful chemicals than cigarettes, supports full switching from combustible products, and maintains low uptake among unintended populations, including youth.

PMI also highlighted that ZYN is an evolution of Swedish Snus, the first oral tobacco product to receive an MRTP designation in 2019. ZYN itself became the first nicotine pouch product authorised by the FDA via the Premarket Tobacco Product Authorisation (PMTA) pathway in January 2025. PMI says an MRTP designation would allow the company to communicate the product’s reduced-risk profile to adult consumers.