FDA WARNING_LETTER - Ecig Charleston LLC - October 01, 2025

The FDA issued a Warning Letter to Ecig Charleston LLC on October 16, 2025, concerning its manufacture, sale, and distribution of e-liquid products in the United States. The FDA"s review indicated that the company markets the "Fallen Angel" e-liquid, which is classified as a "new tobacco product." Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and specifically through a recent amendment extending FDA"s jurisdiction to products containing nicotine from any source, such new tobacco products are required to obtain premarket authorization before being legally marketed.

Ecig Charleston LLC"s "Fallen Angel" product lacks this necessary marketing authorization. As it was not commercially available before February 15, 2007, and does not possess FDA approval, the product is considered unlawfully marketed. This failure to secure authorization renders the product both out of compliance with standards for safety and quality, and improperly labeled due to the absence of required premarket submission information, as defined by the FD&C Act.

The FDA requires Ecig Charleston LLC to submit a written response within 15 working days. This response must detail the corrective actions taken to address the violations, including specific dates when the sale or distribution of the non-compliant e-liquid products ceased, and a plan for maintaining continuous adherence to FDA regulations. Failure to comply could lead to further enforcement actions, such as financial penalties, product seizure, or legal injunctions. The company is responsible for ensuring all its tobacco products meet the applicable provisions of the FD&C Act.