FDA WARNING_LETTER - Ecig Charleston LLC - April 09, 2024

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

The primary violation identified is the marketing of "Green Apple" e-liquid without the required premarket authorization order. This product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided under section 905(j).

The FDA requires Ecig Charleston LLC to take prompt action to address these violations and bring all products into compliance. The company must submit a written response within 15 working days detailing actions taken, including discontinuation dates for violative sales/distribution and a plan for ongoing compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.