E-liquid Brands, LLC – FDA Warning Letter, Dec 20, 2024

On December 18, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to E-liquid Brands, LLC, following a review of inspection records. The letter states that E-liquid Brands, LLC manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, due to containing nicotine from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Prime Salts Hangsen USA 12mg/mL 30 mL" was found to be a new tobacco product not commercially marketed in the U.S. as of February 15, 2007, and lacking an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA requires E-liquid Brands, LLC to submit a written response within 15 working days from receipt of the letter. The response must detail actions taken to address the violations, including dates of discontinued sales/distribution of the violative products, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.