Philip Morris International Gains First FDA MRTP Orders For ZYN Nicotine Pouches

(RTTNews) - Philip Morris International Inc. (PM) announced that the U.S. Food and Drug Administration (FDA) has issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products, marking the first time nicotine pouches have received such authorization.

FDA Authorization

The MRTP orders allow PMI U.S. to market the claim: "Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."

Stacey Kennedy, CEO of PMI U.S., said the decision provides adult nicotine consumers with science-based information and reinforces FDA's evidence-driven approach to evaluating products across the continuum of risk.

Product Portfolio

The FDA's orders cover ZYN flavors including Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth, Chill, and Menthol, each in 3 mg and 6 mg strengths.

ZYN was first authorized for sale in the United States in January 2025 through the premarket tobacco product application pathway. With this latest decision, PMI now holds MRTP authorizations for ZYN, versions of IQOS devices and consumables, and General snus products, underscoring its leadership in smoke-free innovation.

Scientific Basis

FDA's review highlighted that nicotine pouches deliver nicotine orally without burning tobacco, significantly reducing exposure to harmful chemicals compared to cigarettes. Data showed that many adult smokers who switched to ZYN reduced or eliminated cigarette use, with over half reporting no cigarette consumption in the past 30 days.

PMI Outlook

PMI estimates that as of December 31, 2025, over 43 million legal-age consumers worldwide were using its smoke-free products, which accounted for 43% of first-quarter 2026 net revenues. Since 2008, the company has invested more than $16 billion in developing and substantiating smoke-free alternatives, with the long-term goal of ending cigarette sales.

PM has traded between $142.11 and $193.05 over the past year. The stock closed Tuesday's trading at $180.91, down 1.07%.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.