FDA WARNING_LETTER - Ecig Charleston LLC - May 09, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to Ecig Charleston LLC following a review of inspection records, identifying the firm's manufacture and distribution of e-liquid products. These products, including those containing nicotine from any source, are regulated as tobacco products under the FD&C Act. The primary violation cited is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the "Blueberry" e-liquid product was found to be a new tobacco product, not commercially marketed before February 15, 2007, and lacking an FDA marketing authorization order. Consequently, this 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 notice under section 905(j). The FDA mandates that Ecig Charleston LLC submit a written response within 15 working days, detailing corrective actions, including the discontinuation of violative sales and a plan for future compliance. Failure to address these violations may result in severe regulatory actions, such as civil money penalties, product seizure, injunctions, or import detentions, underscoring the critical need for adherence to all applicable FD&C Act provisions and regulations.