FDA WARNING_LETTER - Ecig Charleston LLC - July 03, 2024

On July 2, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to Ecig Charleston LLC, identifying violations related to the manufacturing, sale, and distribution of e-liquid products. The FDA determined that Ecig Charleston LLC's "Raspberry" e-liquid product is a "new tobacco product" under section 201(rr) of the FD&C Act because it contains nicotine and was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the lack of required premarket authorization for this new tobacco product. The product does not have an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and is not exempt. Consequently, the "Raspberry" e-liquid 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 under section 905(j) was not provided.

Ecig Charleston LLC is required to submit a written response within 15 working days, detailing actions taken to address the violations, including dates of discontinued 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.