The Food and Drug Administration (FDA) has authorized Philip Morris International to market Zyn nicotine pouches as presenting a lower health risk compared to cigarettes. This decision, announced on June 30, 2026, allows 20 varieties of Zyn to include statements that using Zyn instead of cigarettes reduces the risk of various health issues, including mouth cancer and heart disease. However, the FDA does not classify these products as safe.
The FDA's review indicated that Zyn products expose users to significantly fewer harmful chemicals than traditional cigarettes and may assist some smokers in transitioning away from combustible tobacco. Bret Koplow, acting director of the FDA’s Center for Tobacco Products, emphasized the importance of providing adult consumers with clear, science-based information regarding the relative harms of tobacco products.
Zyn, produced by Swedish Match USA and owned by Philip Morris International, consists of small nicotine-filled pouches that are placed between the lip and gum, and do not contain tobacco leaf. The FDA's decision follows a thorough review process that included input from independent advisers and agency scientists, who generally agreed on the lower health risks associated with these products.
However, public health advocates, including those from the University of California, San Francisco’s Center for Tobacco Control Research and Education, have expressed concerns that the modified risk claim may lead to misunderstandings about the necessity of completely stopping cigarette use. A letter from the center highlighted that the claim could be misinterpreted as FDA approval for cessation, which may not convey the need for complete switching to achieve the stated benefits.
The market for nicotine pouches has seen rapid growth, with Philip Morris reporting nearly 794 million cans of Zyn sold in the United States last year, more than doubling sales from two years prior. Tobacco manufacturers have also sought to expedite the FDA’s authorization process for new nicotine products in response to increasing demand.