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Philip Morris' ZYN ULTRA FDA Authorization Strengthens Smoke-Free Push

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Key Takeaways

  • Philip Morris won FDA marketing authorization for 11 ZYN ULTRA nicotine pouch products in the United States.
  • ZYN ULTRA approvals cover all 9mg variants and one 11mg Smooth variant, with more 11mg products under review.
  • PM's smoke-free products span 109 markets and generated roughly 42% of second-quarter 2026 net revenues.

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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Stocks to Consider

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The consensus estimate for Chefs' Warehouse’s current fiscal-year sales and earnings implies growth of 10.6% and 33.7%, respectively, from the year-ago reported figures. Chefs' Warehouse delivered a trailing four-quarter earnings surprise of 30.4%, on average.

The Vita Coco Company, Inc. (COCO - Free Report) develops, manufactures, markets and distributes coconut water products under the Vita Coco brand name in the United States, Canada, Europe, the Middle East, Africa and the Asia Pacific. COCO currently sports a Zacks Rank #1. The company delivered a trailing four-quarter earnings surprise of 21.9%, on average.

The Zacks Consensus Estimate for Vita Coco’s current fiscal-year sales and earnings indicates growth of 31.6% and 64.7%, respectively, from the year-ago reported numbers. 

Darling Ingredients Inc. (DAR - Free Report) develops, produces and sells sustainable natural ingredients from edible and inedible bio-nutrients in North America, Europe, China, South America and internationally. At present, Darling Ingredients holds a Zacks Rank of 2 (Buy). DAR delivered a trailing four-quarter earnings surprise of 38.9%, on average. 

The consensus estimate for Darling Ingredients’ current fiscal-year sales and earnings implies growth of 11.5% and 926.5%, respectively, from the year-ago figures. 

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