On June 17, 2025, the U.S. Food and Drug Administration (FDA) issued a filing letter to Swedish Match USA, Inc. for its modified risk tobacco product (MRTP) applications for 20 ZYN nicotine pouch products. This action initiates the substantive scientific review portion of the MRTP application review process. During FDA’s review, the agency will determine whether the applications provide the necessary evidence for these specific products to be marketed with a modified risk claim.

The tobacco products in these applications are commonly referred to as nicotine pouches, which are small fiber pouches containing nicotine designed to be placed between a person’s gum and lip. Following an extensive scientific review of the premarket tobacco product applications (PMTAs) for these 20 products, the FDA authorized them for sale in January 2025.

The manufacturer is now seeking to market the 20 ZYN nicotine pouch products with a modified risk claim, which requires by law an additional authorization from the FDA. The company is proposing to use the following claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” FDA’s review will ultimately determine whether the scientific and legal standards are met to market the product as a modified risk tobacco product and will issue an order letter either granting or denying the application.

Starting June 18, 2025, the public may submit comments on these applications on regulations.gov to FDA-2025-N-0835. FDA will post application documents, including amendments, to the CTP website on a rolling basis, as documents will need to be redacted for any confidential information. Once all materials for these applications have been made publicly available, FDA will announce a closing date for the comment period. The closing date will be no earlier than 180 days from the date of the Federal Register notice and at least 30 days from the date FDA posts the last group of application materials.

In addition to the public comment, and consistent with requirements of the 2009 Family Smoking Prevention and Tobacco Control Act, FDA’s Tobacco Product Scientific Advisory Committee (TPSAC) must also be convened to discuss the merits of the application. Details of the TPSAC meeting are forthcoming.