Philip Morris International Inc (NYSE: PM) announced that the US Food and Drug Administration (FDA) has issued Marketing Granted Orders to its US affiliate, Swedish Match USA, Inc, for 11 ZYN ULTRA moist oral nicotine pouch products. The authorization covers all nine 9mg variants and one 11mg variant, while additional 11mg products remain under scientific review.
The FDA decision expands the company’s portfolio of authorized nicotine pouch products in the United States and strengthens ZYN’s position in the smoke-free category. ZYN ULTRA contains no tobacco leaf and features a higher moisture content than the company’s existing ZYN nicotine pouches.
“We are delighted with the FDA’s decision to authorize a range of ZYN ULTRA products, which will build on ZYN’s position as America’s leading smoke-free product brand,” 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.”
The newly authorized 9mg products include ZYN ULTRA Smooth, commercialized as Signature Smooth; Cool Mint, sold as Arctic Mint; Spearmint, sold as Fresh Spearmint; Wintergreen, sold as Wintergreen Blast; Peppermint, sold as Peppermint Frost; Citrus, sold as Citrus Zest; Chill, sold as Chill Mist; Menthol, sold as Menthol Ice; Deep Freeze; and Wintergreen Chill.
The FDA has also authorized ZYN ULTRA Smooth in an 11mg nicotine concentration, commercialized as Signature Smooth. The products add higher-strength options to ZYN’s existing FDA-authorized portfolio. The latest decision follows the FDA’s earlier authorization of ZYN nicotine pouches in multiple flavors and in 3mg and 6mg strengths. ZYN was the first nicotine pouch authorized for sale in the United States following FDA scientific review.
PMI said the new authorizations reflect its continued focus on developing smoke-free products and supporting responsible marketing to legal-age consumers aged 21 and above. The company has invested more than $16 billion since 2008 in the development, scientific assessment and commercialization of smoke-free products.
As of June 30, 2026, PMI’s smoke-free products were available in 109 markets. The company estimated that more than 43 million legal-age consumers worldwide used its smoke-free products as of December 31, 2025. Smoke-free products represented approximately 42% of PMI’s total net revenues in the second quarter of 2026. PMI said its U.S. businesses employ more than 3,000 people and operate manufacturing facilities in Colorado, Kentucky and North Carolina, alongside operations at locations across the country.
