FDA lets ZYN claim lower health risks than cigarettes

The Food and Drug Administration on June 30 gave 20 ZYN nicotine pouch products made by Swedish Match USA, Inc. permission to be marketed as less harmful than cigarettes. The 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 modified-risk order applies only to those specific products, not to nicotine pouches as a category. The same ZYN products had already been authorized for sale in the United States since January 2025, and the FDA weighed scientific evidence, consumer understanding, population-level impact and youth risk before deciding the claim could be supported. The agency will keep monitoring youth use and company compliance with marketing restrictions.

Bonnie Halpern-Felsher, a Stanford University pediatrics professor and founder and director of the REACH Lab, says nicotine pouches such as Zyn are increasingly popular among young people, and youths are especially vulnerable to nicotine addiction. The FDA’s action does not make ZYN safe, but it lets the company market the products as less harmful than cigarettes for some adults.

In the 2024 National Youth Tobacco Survey, 1.8% of U.S. middle and high school students reported current use of nicotine pouches, and pouches were the second most commonly used tobacco product among youths after e-cigarettes. 10.1% of high school students and 5.4% of middle school students reported current use of any tobacco product.

FDA’s 2025 youth tobacco summary put about 2 million middle and high school students in the current tobacco-use category, while nicotine pouch use remained low and stable at 1.7% overall even as e-cigarette and cigarette use declined.