FDA WARNING_LETTER - Liquid Labs USA, LLC, d/b/a Likido Labs USA - February 01, 2021

On February 10, 2021, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Liquid Labs USA, LLC, operating as Likido Labs USA. The letter, based on FDA submissions and inspection records, identified that the company manufactures and distributes e-liquid products, specifically Vape SZNS Salty SZN Porn Berry Salts, Kapital Grape Salts, and Neon Sours Salts, which are considered tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act. The primary violation stems from the marketing and distribution of these e-liquids without the required FDA marketing authorization. As "new tobacco products" not commercially marketed before February 15, 2007, they are subject to premarket review requirements. The absence of such authorization renders them adulterated and misbranded under the FD&C Act. Introducing these products into interstate commerce constitutes a prohibited act. Liquid Labs USA is required to immediately cease the sale and distribution of the violative products and take all necessary actions to comply with the FD&C Act. A written response is mandated within 15 working days, detailing corrective measures, including the discontinuation dates of the products, and a plan for sustained compliance. Failure to comply may result in further FDA enforcement actions, such as civil money penalties, criminal prosecution, seizure, or injunction.