FDA WARNING_LETTER - Electric Lotus, LLC - March 13, 2025

On March 13, 2025, the FDA issued a Warning Letter to Electric Clouds, LLC, following a review of inspection records, determining the company manufactures, sells, and/or distributes e-liquid products in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction and compliance requirements. The letter highlights that as of March 15, 2022, the definition of "tobacco product" expanded to include products containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization. Specifically, the e-liquid product "Acai Blast" was cited as a new tobacco product not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required information under section 905(j) was not provided.

Electric Clouds, LLC is required to submit a written response within 15 working days detailing actions taken to address these violations, including dates of discontinued sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The letter emphasizes the company's responsibility to ensure