Pakistan, July 08, 2026: The U.S. Food and Drug Administration has authorized 20 ZYN nicotine pouch products to be marketed in the United States with a specific modified risk claim, following a scientific review of applications submitted by Swedish Match USA, Inc.

The FDA issued the Modified Risk Tobacco Product orders on June 30, 2026. The authorization applies only to the 20 reviewed ZYN products in the U.S. market and does not cover an entire category of nicotine or tobacco products.

Under the FDA order, the authorized products may 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 FDA said its review considered evidence on relative health risks for tobacco users, consumer understanding of the claim, youth-related risks and the possible impact on the population as a whole. The agency concluded that Swedish Match had demonstrated the claim was scientifically accurate for the specific products reviewed and that consumers understood its meaning.

The products covered by the orders include 10 ZYN varieties, each in 3 mg and 6 mg nicotine strengths: Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint and Wintergreen.

The same ZYN products were previously authorized for sale in the United States through the FDA’s Premarket Tobacco Product Application pathway in January 2025.

Bret Koplow, acting director of the FDA’s Center for Tobacco Products, said the agency’s review of modified-risk products is intended to ensure that adult users receive clear, science-based information about the relative harms of tobacco products so they can make informed choices.

The FDA’s latest decision marks the first time the agency has granted Modified Risk Tobacco Product orders for nicotine pouches. However, the authorization does not mean the products are risk-free, approved for quitting smoking, or suitable for people who do not use nicotine.

The orders are also subject to post-market surveillance and reporting requirements, meaning Swedish Match must continue monitoring the products and provide information to the FDA after authorization.

Philip Morris International said the decision forms part of its broader smoke-free product portfolio. Swedish Match is part of Philip Morris International.

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