FDA WARNING_LETTER - Twinroll Service AB - April 03, 2024

The FDA issued a Warning Letter to Jonas Lindkvist on April 3, 2024, for violations related to the sale of nicotine pouch products on https://www.whitepouches.com/us and https://snuscore.com/en-us. The FDA determined these products are "tobacco products" under the FD&C Act, including those containing nicotine from any source, and are subject to FDA jurisdiction.

The letter identifies two primary violations: 1. **Marketing of New Tobacco Products Without Required Authorization:** Products like ZYN Espressino Mini Dry Extra Strong, ZYN Mini Black Cherry Light, ZYN Espressino Mini Dry Light #2, and ZYN Lemon Spritz Normal Slim #2 are considered "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007. These products lack the required FDA marketing authorization orders, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. 2. **Sale of Tobacco Products to Individuals Under 21:** Investigations revealed sales of nicotine pouch products to persons under 21 years of age from both websites, violating section 906(d)(5) of the FD&C Act. This renders the products misbranded under section 903(a)(7)(