FDA authorizes 11 Philip Morris ZYN ULTRA nicotine pouch products

The U.S. Food and Drug Administration issued Marketing Granted Orders for 11 ZYN ULTRA moist oral nicotine pouch products made by Swedish Match USA, a Philip Morris International affiliate. The authorization covers 10 flavors with 9mg nicotine and one 11mg Smooth variant, while other 11mg products remain under scientific review. The decision expands earlier FDA authorizations for ZYN products in multiple flavors and 3mg and 6mg strengths. Philip Morris began commercializing ZYN ULTRA in June 2026 under recent FDA guidance and is increasing investment in domestic production as British American Tobacco's Velo Plus gains market share. Nicotine pouches, which deliver nicotine when placed under the lip, are the fastest-growing nicotine category in the United States.

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