FDA issues modified risk orders for 20 ZYN nicotine pouch products

Philip Morris International (PMI) said the U.S. Food and Drug Administration (FDA) has authorised the company to market its ZYN nicotine pouches with reduced-risk claims compared to cigarettes, marking the first such approval for a nicotine pouch product in the United States.

According to PMI, the FDA issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN, allowing the company to market the products with 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 company said the decision makes ZYN the first nicotine pouch product to receive FDA authorisation for reduced-risk marketing claims. The approved products include multiple flavours such as Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth, Chill and Menthol in 3 mg and 6 mg nicotine strengths.


PMI U.S. CEO Stacey Kennedy said the FDA's decision gives adult nicotine users access to "accurate, science-based information" about the health risks associated with switching completely from cigarettes to ZYN. She added that the decision reinforces the FDA's science-based approach to evaluating smoke-free alternatives.

According to PMI, the regulator concluded that, as used by consumers, the authorised ZYN products could significantly reduce harm and the risk of tobacco-related disease for individual users compared with continued cigarette smoking while also benefiting public health.

Nicotine pouches deliver nicotine through oral absorption without burning tobacco or producing smoke. According to the company, this reduces users' exposure to many harmful chemicals found in combustible cigarettes.

PMI also noted that ZYN became the first nicotine pouch to receive FDA marketing authorisation under the Premarket Tobacco Product Application (PMTA) pathway in January 2025. With the latest decision, the company said it now holds FDA Modified Risk Tobacco Product authorisations across multiple smoke-free product categories, including ZYN, IQOS heated tobacco products and General snus products.