FDA WARNING_LETTER - Black Hills Vapors LLC - October 15, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Black Hills Vapors LLC, a registered manufacturer of e-liquid products, after determining that their Dakota Juice Co. Dakota Lemonade 03 mg 30 ml e-liquid product is being manufactured and distributed without the required premarket authorization. As a "new tobacco product" under section 910(a) of the FD&C Act, it requires a marketing authorization order or an exemption, which the firm failed to obtain. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of required information under section 905(j). The letter also cites prohibited acts under section 301(k) for marketing adulterated/misbranded products and section 301(p) for failing to provide the necessary report. The FDA emphasizes that all new tobacco products marketed without authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. Black Hills Vapors LLC must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative sales and a plan for maintaining compliance with the FD&C Act.