Island Ecig & Vape Co – FDA Warning Letter, Oct 19, 2022

The FDA issued a Warning Letter to Island E-Cig and Vape Co. after determining the company manufactures and distributes Beetlejuice e-liquid products without required marketing authorization. These e-liquid products are classified as 'new tobacco products' under section 201(rr) of the FD&C Act, meaning they were not commercially marketed in the U.S. as of February 15, 2007, and thus require premarket authorization under section 910(a). The firm's failure to obtain this authorization renders their products adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the absence of a required 905(j) report. The letter also cites prohibited acts under sections 301(k) for holding adulterated/misbranded products for sale and 301(p) for failing to provide the necessary report. The FDA mandates a written response within 15 working days detailing corrective actions, including dates of discontinuing violative sales and a plan for future compliance, warning of potential regulatory actions like civil money penalties, seizure, or injunction for non-compliance.