FDA WARNING_LETTER - Consolidated Trading, Inc., d/b/a Blue Ox Vapor - October 02, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Consolidated Trading, Inc., d/b/a Blue Ox Vapor, after reviewing inspection records. The firm manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source. The letter states that Blue Ox Vapor is marketing "new tobacco products" without the required premarket authorization. Specifically, the Blue Ox Vapor French Vanilla 6 mg/ml 8oz e-liquid product was identified as a new tobacco product not commercially marketed before February 15, 2007, and lacking an FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice under section 905(j). The FDA requires a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction, and imported products may be detained.