FDA WARNING_LETTER - Liquid Labs USA, LLC, d/b/a Likido Labs USA - August 08, 2019

The FDA issued a Warning Letter to Liquid Labs USA, LLC, d/b/a Likido Labs USA, after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products classified as tobacco products under the FD&C Act. The letter identifies that Vape SZNS Salty SZN Pom Berry Salts, Kapital Grape Salts, and Neon Sours Salts e-liquids are adulterated under section 902(6)(A) and/or misbranded under section 903(a)(6) of the FD&C Act. This is due to the absence of required FDA marketing authorization orders and/or failure to provide necessary notices or information for these products. As these e-liquids were not commercially marketed in the U.S. as of February 15, 2007, they are considered "new tobacco products" subject to premarket review requirements under section 910(a) of the FD&C Act. The introduction of such adulterated or misbranded products into interstate commerce is a prohibited act under section 301(a), and failure to provide required reports under section 905(j) is a prohibited act under section 301(p). Liquid Labs USA is required to immediately correct these violations, discontinue the sale and distribution of the non-compliant products, and submit a written response within 15 working days detailing corrective actions, discontinuation dates, and a compliance plan. Failure to comply could lead to civil money penalties, criminal prosecution, seizure, and/or injunction.