FDA WARNING_LETTER - Cloud House Vape - October 05, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Cloud House Vape after reviewing inspection records, determining the company manufactures and distributes e-liquid products, specifically "Mango Pearfection," without required premarket authorization. These products are classified as "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed before February 15, 2007, and lack FDA marketing authorization. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j). The letter also cites prohibited acts under section 301(k) for holding adulterated or misbranded products for sale after interstate shipment, and under section 301(p) for failing to provide a required report. Cloud House Vape must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for maintaining compliance. Failure to address these violations may lead to regulatory actions such as civil money penalties, seizure, or injunction.