Vapor Dynasty LLC – FDA Warning Letter, Nov 17, 2022

The FDA issued a Warning Letter to Vapor Dynasty, LLC, after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically Vapor Dynasty BlueHoney 15ml/03mg e-liquid, which are deemed tobacco products under the FD&C Act. The primary violation is that this e-liquid is a "new tobacco product" that was commercially marketed without the required premarket authorization order from the FDA. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the necessary notice or information under section 905(j) was not provided. Furthermore, the sale of such adulterated or misbranded products constitutes a prohibited act under section 301(k), and the failure to provide the required report under section 905(j) is a prohibited act under section 301(p) of the FD&C Act. The FDA mandates prompt action to address these violations, including discontinuing violative sales and submitting a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may lead to regulatory actions such as civil money penalties, seizure, or injunction.