FDA WARNING_LETTER - Old Pueblo Vapor LLC - August 17, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Old Pueblo Vapor LLC after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically HONEYDEW STRAWPEARY 0.3% 120 mL. These products are classified as "new tobacco products" under the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007. The firm is in violation for manufacturing and distributing this e-liquid without the required premarket marketing authorization order (section 910(c)(1)(A)(i)). As a result, the HONEYDEW STRAWPEARY 0.3% 120 mL e-liquid is deemed adulterated (section 902(6)(A)) and misbranded (section 903(a)(6)) due to the absence of required information under section 905(j). The letter also cites prohibited acts under section 301(k) for holding adulterated/misbranded products for sale and section 301(p) for failing to provide the necessary report. Old Pueblo Vapor LLC, a registered manufacturer with numerous products, is responsible for ensuring compliance. The company must submit a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales and a compliance plan. Failure to comply could result in civil money penalties, seizure, or injunction.