Philip Morris' ZYN ULTRA FDA Authorization Strengthens Smoke-Free Push
PM's FDA authorization for 11 ZYN ULTRA nicotine pouches expands its U.S. smoke-free portfolio and supports the long-term transformation.
Philip Morris International Inc. PM continues to advance its smoke-free transformation, with regulatory progress in the United States adding another potential growth lever. The FDA has authorized Swedish Match USA, Inc., a U.S. affiliate of Philip Morris International, to market 11 ZYN ULTRA moist oral nicotine pouch products following scientific review, broadening the company’s presence in the U.S. nicotine pouch category.
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, is free of tobacco leaf. The latest action builds on earlier FDA authorizations for ZYN’s 3mg and 6mg variants and broadens Philip Morris’ portfolio of smoke-free alternatives for legal-age nicotine consumers.
The development broadens Philip Morris’ ability to serve legal-age nicotine consumers with a wider range of smoke-free alternatives. ZYN ULTRA also extends the brand into higher-strength offerings, potentially improving its reach across different consumer preferences. Philip Morris began commercializing ZYN ULTRA in June 2026 under recent FDA guidance, making the latest authorization an important regulatory step for the expanded range.
The decision adds to a series of FDA actions involving Philip Morris’ smoke-free portfolio. Earlier, 20 ZYN nicotine pouch variants received Modified Risk Tobacco Product authorizations. Versions of IQOS devices and consumables, along with General snus, have also received FDA marketing authorizations, highlighting the company’s growing regulatory footprint across smoke-free categories.
Overall, the ZYN ULTRA authorization reinforces Philip Morris’ long-term push to shift its portfolio toward smoke-free products. With the smoke-free products available across 109 markets and its smoke-free business accounting for roughly 42% of second-quarter 2026 net revenues, continued regulatory progress in the United States could support broader portfolio expansion and strengthen the company’s position in the smoke-free category.
Philip Morris’ Zacks Rank & Share Price Performance
Shares of this Zacks Rank #3 (Hold) company have fallen 2.5% over the past month against the broader Consumer Staples sector and the S&P 500 index’s growth of 2.2% and 3.8%, respectively. PM has outperformed the industry’s decline of 5.2% in the same period.
PM Stock's Past Month Performance
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Is PM a Value Play Stock?
Philip Morris currently trades at a forward 12-month P/E ratio of 21.22, which is up from the industry average of 15.16 and the sector average of 17.32. This valuation positions the stock at a premium relative to both its direct peers and the broader consumer staples sector.
PM P/E Ratio (Forward 12 Months)
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This article originally published on Zacks Investment Research (zacks.com).