FDA WARNING_LETTER - Ecig Charleston LLC - April 12, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Ecig Charleston LLC on April 4, 2024, based on a review of inspection records. The company manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source.

The primary violation identified is the marketing of "Blue Razz Chiller" e-liquid without the required premarket authorization. This product is deemed a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, nor is it exempt. Consequently, the product is 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 or information under section 905(j).

Ecig Charleston LLC is required to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuation dates for the violative sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.