FDA WARNING_LETTER - The Vape Zone LLC - February 29, 2024

The FDA Center for Tobacco Products issued a Warning Letter to The Vape Zone LLC after reviewing inspection records, determining the company manufactures and distributes e-liquid products, including "Berry Crunch," which are classified as tobacco products under section 201(rr) of the FD&C Act. These products are subject to FDA jurisdiction and regulatory requirements. The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notices under section 905(j) were not provided. The letter also cites prohibited acts under section 301(k) for marketing adulterated/misbranded products and section 301(p) for failing to provide required reports. The firm is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.