Mid Cities Vapor LLC – FDA Warning Letter, Jun 16, 2023

The FDA issued a Warning Letter to Mid Cities Vapor LLC after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, which are deemed tobacco products subject to FDA regulation. The letter highlights that certain e-liquid products, specifically citing "F29 3MG 100ML," are "new tobacco products" that were not commercially marketed before February 15, 2007, and lack the required premarket authorization (PMTA, SE, or exemption) under section 910 of the FD&C Act. Consequently, these unauthorized products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required information under section 905(j). The FDA also cited prohibited acts under sections 301(k) for marketing adulterated/misbranded products and 301(p) for failing to provide required reports. Although the firm has pending PMTAs for other products, it continues to market unauthorized ones, which are considered unlawful. Mid Cities Vapor LLC must promptly address these violations, discontinue the sale and distribution of non-compliant products, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.