Philip Morris claims FDA nod to market ZYN nicotine pouch as safer than smoking
According to PMI, the FDA issued Modified Risk Tobacco Product (MRTP) orders for 20 varieties of ZYN, allowing the company to market the products with the claim: “Using ZYN as a cigarette substitute reduces the risk of oral cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
The decision makes ZYN the first nicotine pouch product to receive FDA approval for reduced-risk marketing claims, the company said. Approved products include many flavors such as Cool Mint, Spearmint, Mint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth, Chill and Menthol in 3 mg and 6 mg nicotine grades.
PMI USA 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. He added that the decision strengthens the FDA’s science-based approach to evaluating smoke-free alternatives.
According to PMI, the regulator concluded that when used by consumers, authorized ZYN products can significantly reduce harm and the risk of tobacco-related disease for individual users compared to continuing to smoke, while also providing public health benefits.
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 is the first nicotine pouch to receive FDA marketing authorization under the Pre-Marketing Tobacco Product Application (PMTA) pathway in January 2025. With the latest decision, the company said it now has FDA Modified Risk Tobacco Product clearances across multiple smokeless product categories, including ZYN, IQOS heated tobacco products, and Generic snus products.
