FDA WARNING_LETTER - snusport.com - August 05, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter on July 25, 2025, to the operators of the website https://www.snusport.com regarding the sale of nicotine pouch products in the United States. The inspection revealed that the products, specifically Zyn Slim Violet Licorice 9mg and Zyn Slim Red Fruits 6.5mg, are being marketed without the required premarket authorization. These products fall under the FDA"s jurisdiction as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was amended in 2022 to include products containing nicotine from any source.

The FDA identified these products as "new tobacco products" because they were not commercially available in the U.S. before February 15, 2007, and lack the necessary marketing authorization. Consequently, they are considered adulterated and misbranded under sections 902 and 903 of the FD&C Act.

The FDA requires the company to cease the sale and distribution of these products and to ensure compliance with the FD&C Act. The company must submit a written response within 15 working days detailing corrective actions, including the cessation of sales and plans for compliance. Failure to comply may result in regulatory actions such as civil penalties, seizure, or injunction. The letter serves as a formal notification and offers the company an opportunity to address the violations.