FDA to allow Zyn nicotine pouches to be marketed as less harmful than cigarettes

The Food and Drug Administration will allow Philip Morris International to market Zyn nicotine pouches as presenting a lower health risk than cigarettes.

The decision announced Tuesday authorizes 20 varieties of Zyn to carry language stating that “using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” The order does not declare the products safe, but it allows the company to promote them as a less harmful alternative for adult smokers who switch from cigarettes.

The FDA said its review found the products “would significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population ‌as ⁠a whole.”

The agency said the decision was based on scientific evidence showing the nicotine pouches expose users to substantially fewer harmful chemicals than cigarettes and could help some smokers transition away from combustible tobacco.

Bret Koplow, acting director of the FDA’s Center for Tobacco Products, said the agency’s modified-risk review process is designed to ensure adult consumers receive “clear, science-based information about the relative harms of tobacco products, so they can make informed choices.”

Zyn, which is manufactured by Swedish Match USA and owned by Philip Morris International, consists of small nicotine-filled pouches placed between the lip and gum. Unlike traditional chewing tobacco or cigarettes, the products generally do not contain tobacco leaf. In 2025, Zyn became the first nicotine pouch product authorized for sale by the FDA following an extensive scientific review.

The FDA’s latest action follows months of review after Philip Morris sought permission to make modified-risk claims. Independent advisers and agency scientists had generally agreed that the products present fewer health risks than cigarettes.

Public health advocates, such as those at the University of California, San Francisco’s Center for Tobacco Control Research and Education, voiced opposition to the modified risk claim because it does not communicate that nicotine users must completely stop smoking cigarettes.

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A January letter from the center said the “claim is likely to be misinterpreted to mean that ZYN nicotine pouches have been approved by FDA for cessation and consumers do not understand that they need to switch completely to get the purported benefits.”

The nicotine pouch market has expanded rapidly in recent years. Philip Morris sold nearly 794 million cans of Zyn in the United States last year, more than doubling its sales from two years earlier. Tobacco manufacturers have also pressed the Trump administration to streamline the FDA’s authorization process for newer nicotine products as demand continues.