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

The United States 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. ZYN is one of the smoke-free products of Philip Morris International, the parent company of PT HM Sampoerna Tbk.

The decision allows the authorised ZYN products to be marketed in the United States with claims approved by the FDA.

Under the decision announced on 30 June 2026, the FDA permits ZYN variants that have received MRTP authorisation to be marketed in the United States with the claim 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.

The decision marks the first time the FDA has granted MRTP authorisation to the nicotine pouch category. Previously, in January 2025, the FDA had also authorised the marketing of several ZYN variants in the United States through the Premarket Tobacco Product Application (PMTA) pathway, following a scientific review process.

The FDA affirmed that its review of products with modified risk claims aims to ensure that adult consumers have access to clear, science-based information about the differences in risk levels between tobacco products.

Acting Director of the FDA Center for Tobacco Products, Bret Koplow, said the decision allows these products to be marketed with modified risk claims that inform adult consumers about the lower risks associated with the products compared to cigarettes.

“During the evaluation process, the FDA reviewed a range of scientific aspects, including the products’ relative health risks for adult consumers, adult consumers’ understanding and perception of the proposed risk claims, and the products’ impact on public health as a whole,” he said on Monday (20/7/2026).

The FDA also considered recommendations from the Tobacco Products Scientific Advisory Committee meeting on 22 January 2026, public input, data and information submitted to the FDA, and other scientific information identified by the agency.

The products granted MRTP authorisation comprise 10 ZYN flavours, each in two nicotine strengths of 3 milligrams and 6 milligrams. The variants include ZYN Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint and Wintergreen, bringing the total to 20 ZYN variants covered by the FDA decision.

Philip Morris International stated that the FDA decision represents an important milestone for adult nicotine consumers of legal age in the United States.

“The FDA decision ensures that adult consumers have access to accurate, science-based information, including FDA-authorised evidence on the reduction in smoking-related disease risks when switching from cigarettes to ZYN,” said PMI U.S. CEO Stacey Kennedy.

Nicotine pouches such as ZYN deliver nicotine through oral absorption and involve neither the combustion of tobacco nor the inhalation of smoke.

In the context of the earlier 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 other smokeless tobacco products, such as moist snuff and snus.