ZYN Nicotine Pouches: U.S. FDA authorizes 20 products with modified risk claim
The decision allows the products to be marketed in the United States with an FDA-authorized claim stating they present lower health risks than cigarettes for adults who smoke.
The U.S. FDA has authorized 20 ZYN nicotine pouch products with a modified risk claim.
ZYN Nicotine Pouches have received Modified Risk Tobacco Product (MRTP) authorization from the U.S. Food and Drug Administration (FDA), allowing 20 products to be marketed in the United States with a specific FDA-approved modified risk claim following an extensive scientific review.
The FDA issued the orders on June 30 after reviewing applications submitted by Swedish Match USA, Inc. The agency evaluated scientific evidence on the products’ relative health risks, consumer understanding of the proposed claim, potential youth impact and the overall effect on public health.
The authorization applies only to the 20 ZYN nicotine pouch products reviewed by the FDA and is limited to the United States. It does not extend to other nicotine pouch products or the broader category of tobacco and nicotine products.
The FDA concluded that the evidence demonstrated the authorised claim is scientifically supported, that consumers understand its meaning and that allowing the products to carry the claim would benefit public health.
The 20 ZYN nicotine pouch products were previously authorised for sale in the United States through the Premarket Tobacco Product Application (PMTA) pathway in January 2025. Under the new order, they may now carry the FDA-authorised statement:
“Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
In a statement announcing the decision, Bret Koplow, Acting Director of the FDA’s Center for Tobacco Products, said the agency’s review process aims to ensure adult tobacco users receive clear, science-based information about the relative risks of tobacco products so they can make informed decisions. He added that the order allows the products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products.
The FDA said the decision marks the first time it has granted Modified Risk Tobacco Product orders for nicotine pouches.
The authorisation remains subject to the terms of the FDA order, including ongoing post-market surveillance and reporting requirements.
