DKD Vapor LLC d/b/a Phoenix Rising Vapor – FDA Warning Letter, Jun 15, 2022

The FDA issued a Warning Letter to DKD Vapor LLC d/b/a Phoenix Rising Vapor after reviewing submissions and inspection records, determining the company manufactures and distributes Carina e-liquid products. These e-liquids are classified as "new tobacco products" under the FD&C Act, subject to FDA jurisdiction and requiring premarket authorization. The firm was found to be manufacturing, selling, and distributing these products without the necessary marketing authorization order, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA approval. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket notification under section 905(j). The letter highlights that causing adulteration or misbranding, and failing to provide required reports, constitute prohibited acts under sections 301(k) and 301(p) respectively. Despite being a registered manufacturer with numerous listed products, the firm failed to comply with critical premarket authorization requirements. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance, warning of potential regulatory actions like civil money penalties, seizure, or injunction for continued non-compliance.