FDA Authorizes Lower Disease Risk Claim for Select Philip Morris Zyn Nicotine Pouches

The U.S.

Food and Drug Administration on Tuesday granted modified risk tobacco product (MRTP) orders to Philip Morris International Inc.’s (NYSE: PM ) subsidiary for 20 ZYN nicotine pouch products.

The update allows the company to market them with claims that switching completely from cigarettes to the products lowers the risk of several smoking-related diseases.

The decision follows an extensive scientific review and applies only to the authorized ZYN products, not to nicotine pouches as a broader category.

Read Also: Philip Morris' Expansion Plans For Smoke-Free Products Hits Roadblock As India Upholds E-Cigarette Ban FDA Authorizes Reduced Risk Marketing Claim The FDA said the authorized ZYN nicotine pouches, which have been approved for sale in the U.S. since January 2025, may now carry 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.” The modified risk orders cover 10 ZYN varieties—Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen—each available in 3 milligram and 6 milligram nicotine strengths.

The agency emphasized that MRTP orders apply only to the specific products reviewed and do not extend to an entire class of tobacco products.

Authorization Includes Ongoing Monitoring Requirements As part of the authorization, Swedish Match company must conduct postmarket surveillance and research to assess consumer behavior and understanding of the modified risk information.

The orders will expire in five years unless the company receives renewed authorization.

The FDA said it may withdraw the orders if continued marketing no longer benefits public health, including if youth uptake rises significantly.

The agency reiterated that no tobacco product is safe and that individuals who do not use tobacco should not start.

To date, the FDA has authorized 26 nicotine pouch products after determining they meet the statutory public health standard.

It’s the first time a nicotine pouch has received the designation and could provide a boost to the popular Zyn brand that has shed market share to competitors in recent months.

The decision lets consumers "make informed choices," Bret Koplow, acting director of the FDA’s Center for Tobacco Products, told Bloomberg. "FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America," Philip Morris U.S.

CEO Stacey Kennedy told CNBC. "Today’s news ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer." PM Stock Price Activity: Philip Morris shares were down 0.90% at $179.27 at the time of publication on Wednesday, according to Pro data.

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