PMI urges US regulator to authorise ZYN as a modified risk tobacco product
January 27, 2026
Experts from Philip Morris International (PMI) last week presented scientific evidence to the US Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) as part of the FDA’s process for a Modified Risk Tobacco Product (MRTP) designation for their ZYN nicotine pouch products.
This designation would allow PMI’s US businesses to communicate to legal-aged, 21+ adult cigarette smokers that switching completely to ZYN reduces their risk of many smoking-related diseases.
“The FDA’s Center for Tobacco Product’s (CTP) mission is to make smoking-related disease and death a part of America’s past,” said Keagan Lenihan, chief external affairs officer for PMI U.S. “Smoke-free products, like ZYN, play a critical role in helping CTP achieve this mission and provide adults who smoke with important information to guide their choices and a real opportunity to change.”
The full-day meeting on January 22 was part of the FDA’s scientific review of PMI-affiliate Swedish Match USA Inc.’s application to use the following proposed reduced risk claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
In their presentation to the committee, The FDA stated : “The evidence suggests the proposed modified risk claim is scientifically accurate.” Additionally, the FDA noted: “Youth nicotine pouch use prevalence is currently relatively low” and “among young adults, viewing the proposed claim did not increase intentions to use ZYN.”
During the meeting, PMI experts presented data showing that exposure to the claim raised awareness that switching from cigarettes to ZYN lowers the risks of developing the six critical health conditions in the claim (i.e., mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis). The data presented also demonstrated that consumers understood ZYN products are not entirely risk-free, and the risk of developing the health conditions in the claim after switching to ZYN is significantly lower compared to continuing cigarettes.
The TPSAC, an independent panel of scientific experts that provides nonbinding recommendations to CTP, reviewed evidence showing that ZYN contains substantially lower levels of harmful chemicals than cigarettes. The evidence also demonstrated that ZYN promotes complete switching to help smokers transition away from combustible products while maintaining low levels of use by unintended populations, including youth. The committee also heard testimony that ZYN nicotine pouches represent the next evolution of Swedish Snus – an oral tobacco product that was the first to receive an MRTP designation from the FDA in 2019 and has been linked to Sweden’s low smoking prevalence and reduced rates of tobacco-related disease.
In January 2025, ZYN became the first nicotine pouch product to receive marketing authorisation from FDA through the Premarket Tobacco Product Authorization (PMTA) pathway. With an MRTP designation, the FDA would recognise and acknowledge the scientific evidence showing that ZYN has a reduced‑risk profile compared to cigarettes. They would also permit this information to be communicated to adult consumers.
The ZYN nicotine pouch products submitted for the MRTP designation are the same products that received PMTA authorization in January 2025.
