2FIRSTS | FDA Grants PMTA Authorization to 11 ZYN ULTRA Nicotine Pouches, Bringing Total Authorized Pouches to 43
FDA authorized 11 ZYN ULTRA nicotine pouch products, bringing the total authorized pouches to 43.Summary
The U.S. Food and Drug Administration (FDA) authorized 11 ZYN ULTRA nicotine pouch products by Swedish Match USA on August 21, 2026, through the premarket tobacco product application (PMTA) pathway. This includes ten products with 9 mg nicotine and one 11 mg product, ZYN ULTRA Smooth. The reviews were conducted under FDA's nicotine pouch PMTA pilot program, which has streamlined the process. With these authorizations, FDA has now approved 43 nicotine pouch products in total, including 23 via the pilot. The FDA evaluates nicotine exposure based on factors beyond labeled content, such as product design and formulation. The authorized products have lower levels of harmful constituents compared to other tobacco products and may support complete switching for adult smokers. Philip Morris International stated that additional ZYN ULTRA 11 mg products are under scientific review. Separately, on June 30, 2026, FDA issued Modified Risk Tobacco Product orders for 20 previously authorized ZYN products.
(Source：2Firsts)
