FDA WARNING_LETTER - Billet Box Vapor, LLC - September 16, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Billet Box Vapor, LLC, after reviewing submissions and inspection records, determining the company manufactures and distributes Electronic Nicotine Delivery Systems (ENDS) products, specifically Billet Box Vapor, #11-G, and Billet Box Vapor, Lab Rat. These products are deemed tobacco products under the FD&C Act and are subject to FDA regulation. The FDA found that these ENDS products are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are 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 or information under section 905(j). The introduction of these adulterated or misbranded products into interstate commerce is a prohibited act under section 301(a), and the failure to provide required reports is a prohibited act under section 301(p). Billet Box Vapor, LLC must submit 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, injunction, and import detention.