FDA Authorises 20 ZYN Variants 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, manufactured by Swedish Match USA, Inc., a smoke-free product affiliate of Philip Morris International, the parent company of PT HM Sampoerna Tbk. The decision, announced on 30 June 2026, permits the authorised ZYN products to be marketed in the United States with the following approved claim: ‘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 in the United States through the Premarket Tobacco Product Application (PMTA) pathway, following a rigorous scientific review process. The FDA emphasised that the review process for products with modified risk claims aims to ensure that adult consumers have access to clear, science-based information regarding the differing levels of risk among tobacco products.

Acting Director of the FDA Center for Tobacco Products, Bret Koplow, stated that the decision allows these products to be marketed with modified risk claims that inform adult consumers about the lower risks associated with these products compared to cigarettes. During its evaluation, the FDA reviewed various scientific aspects, including the relative health risks of the products for adult consumers, adult consumer understanding and perception of the proposed claims, and the overall impact of the products on public health. The agency also considered recommendations from the Tobacco Products Scientific Advisory Committee meeting on 22 January 2026, public comments, submitted data and information, and other scientific information identified by the agency.

The products receiving MRTP authorisation include 10 ZYN flavour variants, each available in two nicotine strengths of 3 milligrams and 6 milligrams. The variants are ZYN Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen, totalling 20 product variants covered by the FDA’s decision. Philip Morris International stated that the FDA’s decision represents 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 and do not involve tobacco combustion or smoke inhalation. In the context of the previous PMTA authorisation in 2025, the FDA stated that the authorised ZYN products contain substantially lower levels of harmful and potentially harmful constituents compared to cigarettes and most smokeless tobacco products, such as moist snuff and snus.