Twenty ZYN products can now carry the authorised claim

The U.S. Food and Drug Administration has authorised 20 ZYN nicotine pouch products to carry a reduced-risk claim against cigarettes. They are the first nicotine pouches to receive Modified Risk Tobacco Product orders.

The order allows PMI U.S. To market this claim for the authorised products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

Philip Morris International Inc., listed on the New York Stock Exchange as PM, announced the decision from Stamford, Connecticut. An editor’s note in the company statement said the FDA-authorised claim took effect immediately.

PMI U.S. CEO Stacey Kennedy called the ruling “an important moment” for more than 45 million legal-age nicotine consumers in America.

She added that the decision gives adults access to FDA-authorised, science-based information that switching from cigarettes to ZYN reduces the risk of smoking-related diseases including heart disease and lung cancer.

Stacey Kennedy and FDA order

The 20 authorised products cover 10 flavours in two strengths each. They are Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth, Chill and Menthol, each in 3 mg and 6 mg versions.

Earlier, in January 2025, ZYN became the first nicotine pouch authorised for sale in the United States after what PMI described as a rigorous scientific review.

According to the FDA’s modified risk granted order, the products satisfied section 911(g)(1)(A) and (B). The agency said the products, as actually used by consumers, would significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and would benefit the health of the population as a whole.

With the new decision, PMI now holds MRTP authorisations for ZYN, versions of IQOS devices and consumables, and eight General snus products.

Meanwhile, the company contrasted the U.S. Process with policies in many other countries, where governments often impose bans instead of carrying out product-by-product scientific reviews.

However, the FDA order applies only to the specified ZYN products and only to the exact reduced-risk claim that the agency authorised.