FDA WARNING_LETTER - LB Vision Holdings, Inc. d/b/a VaperMate #206, LLC - June 08, 2023

The FDA's Center for Tobacco Products issued a Warning Letter to LB Vision Holdings, Inc. d/b/a VaperMate #206, LLC, following a review of submissions and inspection records. The firm manufactures and distributes e-liquid products, including "Green Apple," which are classified as tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine from any source. The primary violation is the marketing of these e-liquid products as "new tobacco products" without the required premarket authorization, as they were not commercially marketed before February 15, 2007. 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 failure to provide required notices or information under section 905(j). Furthermore, the act of holding adulterated or misbranded products for sale after interstate shipment constitutes a prohibited act under section 301(k), and the failure to provide a required report under section 905(j) is a prohibited act under section 301(p). The FDA requires a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance, to avoid further regulatory actions such as civil money penalties, seizure, or injunction.