U.S. Vapes – FDA Warning Letter, Sep 13, 2022

The FDA issued a Warning Letter to U.S. Vapes after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically U.S. Vapes TABBACCO BLEND 1.8% 100mL, which are deemed tobacco products under the FD&C Act. The FDA found that this e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the failure to provide required notice or information under section 905(j). The letter also cites prohibited acts under section 301(k) for holding adulterated/misbranded products for sale after interstate shipment, and under section 301(p) for failing to provide the required report. U.S. Vapes is instructed to take prompt action to address these violations, discontinue the violative sale and distribution of these products, and submit a written response within 15 working days detailing corrective actions and a compliance plan. Failure to comply may lead to regulatory actions including civil money penalties, seizure, and/or injunction.