Disclaimer: This article is based on publicly available information released by the U.S. FDA and interpreted by 2Firsts for informational purposes only. It does not represent the final outcome of the FDA’s scientific or regulatory review. The MRTP applications for ZYN nicotine pouches are still under evaluation and have not yet been approved.
[by 2Firsts]On June 17, 2025, the U.S. Food and Drug Administration (FDA) issued a filing letter to Swedish Match USA, Inc., officially accepting modified risk tobacco product (MRTP) applications for 20 ZYN nicotine pouch products. This acceptance marks the start of the scientific review phase of the MRTP process.
These 20 ZYN products were previously granted marketing authorization in January 2025 after a full review under the premarket tobacco product application (PMTA) pathway. The FDA’s decision marked the first time a group of mainstream nicotine pouch products received such authorization, representing a regulatory milestone for the nicotine alternatives sector. Swedish Match is now seeking to add a modified risk claim to its existing authorization.
FDA is evaluating whether the company has provided sufficient scientific evidence to support the following proposed claim:
“Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
As required by law, such modified risk statements must receive separate FDA authorization. The agency’s review will assess whether the applications meet both scientific and legal standards and will conclude with an order either granting or denying the request.
Beginning June 18, 2025, the public may submit comments on these MRTP applications via regulations.gov, using docket number FDA-2025-N-0835. The FDA will post application materials, including any amendments, on its Center for Tobacco Products (CTP) website on a rolling basis, with redactions for confidential information.
Once all materials have been made available, the FDA will announce the close of the public comment period. This date will be no earlier than 180 days after publication in the Federal Register and no fewer than 30 days following the posting of the final set of documents.
In addition to public comment, the FDA will convene its Tobacco Product Scientific Advisory Committee (TPSAC), as mandated by the 2009 Family Smoking Prevention and Tobacco Control Act, to evaluate the scientific merits of the application. Details on the TPSAC meeting will be announced in due course.
What Is a Modified Risk Tobacco Product (MRTP)?
Under the U.S. Family Smoking Prevention and Tobacco Control Act, a Modified Risk Tobacco Product (MRTP) is a tobacco product that is sold or distributed with claims of reduced harm or risk compared to conventional tobacco products. Such claims must be scientifically substantiated and authorized by the FDA through a separate review process. Applicants must demonstrate that the product, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individuals and the population as a whole. Only after FDA approval can these reduced-risk statements be used in marketing.
