FDA WARNING_LETTER - Ecig Charleston LLC - April 28, 2025

On April 17, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Ecig Charleston LLC, identifying that the company manufactures, sells, and/or distributes e-liquid products, specifically "Riptide," which are considered tobacco products under section 201(rr) of the FD&C Act. These products are subject to FDA jurisdiction and must comply with the FD&C Act and its implementing regulations.

The primary violation cited is the marketing of "new tobacco products" without the required premarket authorization. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after that date. The "Riptide" e-liquid product was determined to be a new tobacco product lacking the necessary FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, and it is not otherwise exempt.

Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act because required notice or information was not provided as per section 905(j).

Ecig Charleston LLC is required to submit a written response within 15 working days from the date of receipt