FDA WARNING_LETTER - Ecig Charleston LLC - January 08, 2025

On January 8, 2025, the FDA Center for Tobacco Products issued a Warning Letter to Ecig Charleston LLC, identifying violations related to the marketing of e-liquid products. The FDA determined that Ecig Charleston LLC manufactures, sells, and/or distributes e-liquid products, specifically "Mango," which are considered tobacco products under section 201(rr) of the FD&C Act.

The primary violation is that the "Mango" e-liquid product is a "new tobacco product" that lacks the required premarket authorization order. This product was not commercially marketed in the United States as of February 15, 2007, and does not have an FDA marketing authorization order in effect, nor is it exempt. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notice or information was not provided under section 905(j).

The FDA mandates that Ecig Charleston LLC take prompt action to address these violations and bring all tobacco products into compliance with the FD&C Act. The company must submit a written response within 15 working days from receipt of the letter, detailing actions taken, including discontinuation dates for violative sales and distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or