The FDA issued Modified Risk Tobacco Product orders for 20 Zyn nicotine pouch variants, allowing Philip Morris International's U.S. unit to market them as carrying a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis than cigarettes. This is the first time any nicotine pouch has received such a designation. The authorization is effective immediately and permits the company to embed FDA-sanctioned health-advantage language directly into advertising and packaging. PMI U.S. CEO Stacey Kennedy said the ruling ensures adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to Zyn reduces the risk of smoking-related diseases. Zyn was first authorized for sale in the United States in January 2025, and Tuesday's orders go further by permitting affirmative reduced-risk claims.
Philip Morris International IncFDA granted reduced-risk marketing orders for 20 Zyn variants, allowing health claims
Altria Group