FDA WARNING_LETTER - E-Cig Central, LLC - September 07, 2021

The FDA issued a Warning Letter to E-Cig Central, LLC, identifying that the company manufactures and distributes e-liquid products, specifically E-Cig CENTRAL ANTIDOTE 1.5mg 30ml e-liquid, which are regulated as tobacco products. The primary violation is the marketing of this "new tobacco product" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. This product was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA marketing authorization. Consequently, the product is 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 information under section 905(j). The letter also cites prohibited acts under sections 301(k) and 301(p) for holding adulterated/misbranded products for sale and failing to provide required reports. E-Cig Central, LLC, a registered manufacturer with over 4,000 listed products, is responsible for ensuring all products comply with the FD&C Act. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a compliance plan. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.