BAM Group LLC d/b/a VapEscape – FDA Warning Letter, Oct 7, 2021

The FDA issued a Warning Letter to BAM Group LLC dba VapeEscape after reviewing submissions and inspection records, determining the firm manufactures and distributes e-liquid products without required marketing authorization. Specifically, Old South Vape Co. Absolutism, Imperium, and Reciprocity e-liquids are deemed "new tobacco products" as they were not commercially marketed before February 15, 2007, and lack FDA marketing 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) due to the absence of required information under section 905(j). The firm's actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The letter also notes a Marketing Denial Order for the firm's Premarket Tobacco Product Application (STN PM0003600) covering 4,050 products. BAM Group LLC must submit a written response within 15 working days, detailing corrective actions, dates of discontinuing violative sales, and a compliance plan to avoid further regulatory action, including civil money penalties, seizure, or injunction.