On June 30th the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 ZYN nicotine pouch products following extensive scientific review, allowing Philip Morris International U.S.(PMI U.S) to market these products in the United States of America (USA) with a specific modified risk claim.
A U.S FDA’s MRTP order authorizes the marketing of specific tobacco or nicotine products in the United States with FDA-authorized modified-risk and/or modified exposure, claims, subject to the terms of the order and applicable post market surveillance and reporting requirements. Such authorization, for the 20 ZYN nicotine pouches, is limited to the USA and applies only to the products reviewed and authorized by the FDA under the relevant orders and does not extend to an entire category or class of tobacco or nicotine products.
The FDA issued the MRTP orders following its scientific review of Swedish Match USA, Inc.’s MRTP applications, including evidence relating to the relative health risks of the product for individuals who use tobacco, consumer understanding and perception of the authorized modified risk claim, data regarding youth risk, and the potential impact on the population. Based on this review, FDA concluded that Swedish Match had demonstrated that the specific modified risk claim is scientifically accurate with respect to these 20 ZYN products, that consumers understand the claim, and that marketing the products with the authorized claim would benefit the population.
With this issuance, these ZYN nicotine pouch products, which were authorized for sale in the USA through the Premarket Tobacco Product Application (PMTA) pathway in January 2025, may now be marketed in the USA with the following FDA authorized risk modification claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
In FDA press release announcing the orders, Bret Koplow, Ph.D., J.D., acting director of the U.S FDA’s Centre for Tobacco Products stated: “FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices.” He further stated that the “decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products.”
The FDA’s latest decision marks the first time the agency has granted MRTP orders for nicotine pouches.
