FDA Authorises 20 ZYN Variants for Marketing with Reduced-Risk Claims Compared to Cigarettes

The U.S. Food and Drug Administration (FDA) has issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouches, owned by Swedish Match USA, Inc., a subsidiary of Philip Morris International. The decision, announced on 30 June 2026, allows the authorised ZYN products to be marketed in the United States with claims that using ZYN as a substitute for cigarettes is associated with a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. This marks the first time the FDA has granted MRTP authorisation for the nicotine pouch category. Previously, in January 2025, the FDA had authorised the marketing of several ZYN product variants through the Premarket Tobacco Product Application (PMTA) pathway. The FDA emphasised that the review process for modified risk claims is designed to ensure adult consumers have access to clear, science-based information about the differing levels of risk among tobacco products. Bret Koplow, Acting Director of the FDA Center for Tobacco Products, stated that the decision allows these products to be marketed with modified risk claims, providing adult consumers with information regarding the lower risks associated with the product compared to cigarettes. The FDA’s evaluation included a review of relative health risks, consumer understanding and perception of the proposed claims, and the overall impact on public health. The agency also considered recommendations from a January 2026 meeting of the Tobacco Products Scientific Advisory Committee, public comments, and other scientific data. The authorised MRTP products include 10 ZYN flavour variants, each available in 3 milligram and 6 milligram nicotine strengths, covering Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen. Philip Morris International described the FDA’s decision as a significant moment for legal-age adult nicotine consumers in the United States. Stacey Kennedy, CEO of PMI U.S., said the decision ensures adult consumers have access to accurate, science-based information, including FDA-authorised evidence regarding the reduced risk of smoking-related diseases when switching completely from cigarettes to ZYN. Nicotine pouches like ZYN deliver nicotine through oral absorption without combustion of tobacco or inhalation of smoke.