FDA WARNING_LETTER - Cool Vape LLC - March 13, 2025

The FDA Center for Tobacco Products issued a Warning Letter to Cool Vape LLC on March 13, 2025, following a review of inspection records. The letter states that Cool Vape LLC manufactures, sells, and/or distributes e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "Blueberry" e-liquid is cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks 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, due to the absence of required notice or information under section 905(j).

Cool Vape LLC is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuation dates for violative sales/distribution and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.