Philip Morris says FDA cleared reduced-harm claim for 20 Zyn variants
The FDA will let 20 Zyn nicotine pouches carry a modified-risk claim that switching from cigarettes lowers the risk of several smoking-related diseases, extending an earlier authorization to sell the products.
The U.S. Food and Drug Administration has allowed 20 Philip Morris-owned Zyn nicotine pouch products to be marketed with a modified-risk claim stating that switching from cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis. The decision gives Philip Morris a significant regulatory and marketing win for one of the fastest-growing nicotine categories in the U.S. as cigarette sales decline and tobacco companies push further into smoke-free products. The same 20 Zyn products were already authorized for sale in January 2025, but that earlier action did not permit Swedish Match, Philip Morris's subsidiary, to promote them as reducing disease risk. Public health critics have warned that flavored pouches, social media promotion and use in places such as workplaces could normalize nicotine use among people who were not previously smokers. Axios first reported the latest FDA action.
- modified-risk claim: An FDA-authorized marketing statement saying a tobacco or nicotine product presents lower health risk than another product under specified conditions.
- nicotine pouches: Small oral pouches placed between the gum and lip to deliver nicotine without smoking.
- smoke-free products: Nicotine products designed for use without burning tobacco, a category tobacco companies are expanding as cigarette sales fall.