Aug. 22 at 12:38 AM
The FDA issued Marketing Orders to Swedish Match USA, a Philip Morris subsidiary, authorizing 11 ZYN ULTRA oral nicotine pouch products in the U.S. The approval covers 10 products at 9mg, including Smooth, Cool Mint, Spearmint, Wintergreen, Peppermint, Citrus, Chill, Menthol, Deep Freeze and Wintergreen Chill, plus Smooth at 11mg. Other 11mg variants remain under scientific review.
PMI said the decision strengthens ZYN’s position as the leading smoke-free nicotine brand in the U.S., where around 45 million people use nicotine products. The approvals build on ZYN’s previously authorized 3mg and 6mg portfolio, making it the first nicotine pouch brand approved for U.S. sale following FDA scientific review.
ZYN ULTRA launched in June 2026 under updated FDA guidance, and PMI has expanded domestic production capacity to meet demand. The company faces increasing competition from products such as British American Tobacco’s Velo Plus, which has gained market share in recent months.
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