FDA WARNING_LETTER - thejuicewarehouse.co.uk - April 01, 2025

The FDA Center for Tobacco Products issued a Warning Letter on March 21, 2025, to The Juice Warehouse after reviewing its website, https://www.thejuicewarehouse.co.uk. The FDA determined that the firm offers electronic nicotine delivery system (ENDS) products, specifically Elf Bar Lost Mary BM600 Disposable Vape Device and HQD EOS Disposable Vape, for sale to U.S. customers without the required premarket authorization. These products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notices under section 905(j). The letter emphasizes that all tobacco products, including those containing nicotine from any source (as per the amended FD&C Act), must comply with FDA regulations. The firm is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.