The U.S. Food and Drug Administration has issued Marketing Granted Orders authorizing the marketing of 11 ZYN ULTRA moist oral nicotine pouch products, Philip Morris International Inc. (NYSE: PM) announced on Friday.
The authorization covers all nine 9mg variants and one 11mg variant of ZYN ULTRA. Nine 9mg variants are approved in flavors including Cool Mint, Spearmint, Wintergreen, Peppermint, Citrus, Chill, Menthol, Deep Freeze and Wintergreen Chill. The single authorized 11mg product is ZYN ULTRA Smooth. Additional 11mg variants remain under scientific review by the FDA.
ZYN ULTRA features higher moisture content than flagship ZYN pouches and contains no tobacco leaf. The products are marketed to consumers aged 21 and older. ZYN was the first nicotine pouch authorized for sale in the U.S. following FDA scientific review, with prior approvals including multiple flavors and 3mg and 6mg variants.
Philip Morris U.S. began commercialization of ZYN ULTRA in June 2026 under recent FDA guidance. The company’s U.S. CEO Stacey Kennedy said the FDA’s decision to authorize the products would help strengthen ZYN’s position as America’s leading smoke-free product brand.
The FDA’s Granted Order states that permitting the marketing of these products is appropriate for the protection of public health. There are approximately 45 million Americans who consume nicotine products.
