The FDA has authorized Swedish Match USA, a U.S. affiliate of Philip Morris International, to market 11 ZYN ULTRA moist oral nicotine pouch products following scientific review. The authorizations cover all 9mg ZYN ULTRA variants and one 11mg Smooth variant, while additional 11mg products remain under FDA review. ZYN ULTRA, which has higher moisture content than the flagship ZYN range and is free of tobacco leaf, extends the brand into higher-strength offerings. Philip Morris began commercializing ZYN ULTRA in June 2026 under recent FDA guidance, and the latest action builds on earlier FDA authorizations for ZYN's 3mg and 6mg variants. The decision adds to a series of FDA actions involving Philip Morris' smoke-free portfolio, including 20 ZYN nicotine pouch variants that received Modified Risk Tobacco Product authorizations and marketing authorizations for IQOS devices and General snus.
Philip Morris International IncFDA authorized 11 ZYN ULTRA nicotine pouch products, expanding PMI's smoke-free portfolio.
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