Pure Vapor USA LP – FDA Warning Letter, Jun 22, 2021

The FDA Center for Tobacco Products issued a Warning Letter to PURE VAPOR USA LP after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically PURE VAPOR Pipe 10MG 10ML e-liquid, which are deemed tobacco products. The FDA found that this product is a "new tobacco product" as it was not commercially marketed before February 15, 2007, and lacks the required premarket marketing 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) 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 sections 301(k) for holding an adulterated/misbranded product for sale and 301(p) for failing to provide a required report. PURE VAPOR USA LP, a registered manufacturer with over 1,400 listed products, is responsible for ensuring compliance. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in civil money penalties, seizure, injunction, or detention of imported products.