The Food and Drug Administration on Tuesday cleared Philip Morris-owned Zyn nicotine pouches to be marketed as less harmful than cigarettes.
The order allows 20 Zyn products to carry a modified-risk claim saying that switching from cigarettes to Zyn lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis and covers flavors such as Cool Mint, Citrus, Coffee, Cinnamon, Menthol, Peppermint, Smooth, Spearmint, Wintergreen and Chill in 3-milligram and 6-milligram strengths; the pouches contain nicotine but not tobacco.
The agency said the decision does not mean Zyn is safe, that there is no safe tobacco product, that youth should not use tobacco products and that adults who do not use tobacco products should not start.
The authorization requires Swedish Match USA, Inc. to study how its customers perceive risks associated with the products for five years and gives the FDA the ability to reverse the action if it sees evidence of a significant increase in youth use.
The FDA’s annual National Youth Tobacco Survey found that 1.7% of middle and high school students reported using nicotine pouches in 2025, with more than 1 in 6 of those users saying they used them every day, and ZYN was the most popular nicotine pouch brand reported.
Mike Seilback, assistant vice president of nationwide advocacy and state public policy at the American Lung Association, called the move "appalling" and said, "The Lung Association calls on the FDA to reverse this action."
The FDA had already authorized the same 20 Zyn products for sale in January 2025, but that earlier decision did not allow Swedish Match, the subsidiary of Philip Morris that makes Zyns, to market them as reducing disease risk; Tuesday's order goes further.
The order gives Philip Morris a stronger health-related marketing claim for Zyn at a time when cigarette sales continue to decline in the U.S. and major tobacco companies are investing more heavily in smoke-free products.