FDA Approves 11 Zyn Ultra Nicotine Pouches

The U.S. Food and Drug Administration has authorized 11 ZYN ULTRA moist oral nicotine pouch products from Philip Morris International’s Swedish Match USA affiliate, including all 9 mg variants and a single 11 mg variant, with additional 11 mg versions still under scientific review. The agency has previously granted modified risk orders for 20 ZYN pouches, allowing limited health-risk claims, as part of its broader review of the product line. In total, the FDA has authorized 43 nicotine pouches, including 23 under a pilot program designed to streamline reviews. PMI executives emphasised ZYN ULTRA’s leadership in the growing smoke-free category and its higher moisture content, positioning the product to compete against rivals such as Velo. The authorizations come as the U.S. nicotine pouch market—already the fastest-growing smokeless category—expands with new flavors and higher-potency options to appeal to adults seeking alternatives to smoking, while PMI continues to invest in ZYN amid competitive pressure.