FDA WARNING_LETTER - Toro Imports, LLC - March 13, 2025

The FDA Center for Tobacco Products issued a Warning Letter to Toro Imports, LLC, after determining the company imports, sells, and distributes electronic nicotine delivery system (ENDS) products in the United States. These products, including those containing nicotine from any source, are regulated as tobacco products under section 201(rr) of the FD&C Act and must comply with its requirements. The FDA found that Toro Imports is marketing "new tobacco products" without the required premarket authorization. Specifically, the product "RR9000 Pink Lemonade 5% NIC 15mL" lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, this product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice under section 905(j) was not provided. The letter states that all new tobacco products marketed without authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, or injunction, and may be detained or refused admission upon import. Toro Imports must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and distribution, and outlining a plan for future compliance.