FDA authorizes 11 ZYN Ultra nicotine pouches for Philip Morris

The U.S. Food and Drug Administration has issued Marketing Granted Orders to Swedish Match USA, Inc., a U.S. affiliate of Philip Morris International (NYSE: PM), authorizing the marketing of 11 ZYN Ultra moist oral nicotine pouch products, according to a company statement.

The authorized products include all 9mg variants and one 11mg variant of ZYN Ultra. Additional 11mg variants remain under scientific review at the FDA. The FDA stated that permitting the marketing of the products "are appropriate for the protection of public health."

The 10 authorized 9mg products include ZYN Ultra Smooth, Cool Mint, Spearmint, Wintergreen, Peppermint, Citrus, Chill, Menthol, Deep Freeze, and Wintergreen Chill. The single authorized 11mg product is ZYN Ultra Smooth. Several of the products are commercialized under different names, such as Arctic Mint and Citrus Zest.

PMI U.S. began commercializing ZYN Ultra in June 2026 under recent FDA guidance. ZYN Ultra contains higher moisture content than the flagship ZYN pouches and is free of tobacco leaf.

The new authorizations follow earlier FDA approvals of ZYN in multiple flavors and 3mg and 6mg variants. The FDA had previously granted modified risk tobacco product orders for certain ZYN nicotine pouches.

"We are delighted with the FDA's decision to authorize a range of ZYN Ultra products," said Stacey Kennedy, PMI U.S. CEO. "We look forward to expanding our portfolio of better choices for the 45 million Americans who consume nicotine products."

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