FDA WARNING_LETTER - Ecig South LLC - April 28, 2025

The FDA's Center for Tobacco Products issued a Warning Letter to ECig Charleston after determining the firm manufactures, sells, and distributes e-liquid products, specifically "Baby Beetle," which are considered tobacco products under the FD&C Act. These products are new tobacco products, not commercially marketed as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed 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. The FDA states that marketing new tobacco products without authorization is unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction. ECig Charleston is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing sales and a plan for maintaining compliance with the FD&C Act and its implementing regulations.