Singing Hawk LLC d/b/a Sin City Vapor – FDA Warning Letter, Aug 23, 2022

The FDA issued a Warning Letter to Singing Hawk LLC d/b/a Sin City Vapor for manufacturing and distributing e-liquid products, which are classified as tobacco products under the FD&C Act, including nicotine from any source. The primary violation identified is the marketing of "Sin City Vapor Hazelnut Heaven 9MG 120ml e-liquid product" without the required premarket marketing authorization order. This product is considered a "new tobacco product" as it was not commercially marketed before February 15, 2007, and therefore requires authorization under section 910(a) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the failure to provide required notice under section 905(j). The letter also cites prohibited acts under sections 301(k) and 301(p) for dealing with adulterated/misbranded products and failing to provide required reports. Sin City Vapor must submit 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.