The U.S. Food and Drug Administration (US FDA) issued Modified Risk Tobacco Product (MRTP) orders on June 30 for 20 nicotine pouch products manufactured by ZYN.
An FDA MRTP order allows certain tobacco or nicotine products to be marketed in the United States with FDA-authorized claims related to “Modified Risk” and/or “Modified Exposure,” provided that the conditions of the order are followed and applicable post-market surveillance and reporting requirements are met.
The authorization issued for these 20 ZYN nicotine pouches is limited to the United States and applies only to the specific products that were reviewed and authorized by the FDA under the relevant orders. This authorization does not extend to the entire tobacco or nicotine product category or to all products within that category.
The FDA issued these MRTP orders after a scientific review of MRTP applications submitted by Swedish Match USA, Inc.
The review examined evidence regarding the products’ relative health risks for people who use tobacco products, consumers’ understanding and perception of the approved Modified Risk Claim, data concerning potential risks to youth, and the possible impact on the overall population.
Based on this review, the FDA concluded that Swedish Match had demonstrated that the specific Modified Risk Claim for these 20 ZYN products is scientifically supported, that consumers understand the claim, and that marketing these products with the claim meets the required legal standards.
These ZYN nicotine pouches, which were authorized for sale in the United States in January 2025 through the Premarket Tobacco Product Application (PMTA) pathway, will now be marketed in the U.S. with the following FDA-authorized Modified Risk Claim:
