FDA WARNING_LETTER - Vaperz Cedar Park - August 10, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to International Vaperz LLC, d/b/a Vaperz Cedar Park, after reviewing submissions and inspection records. The firm manufactures and distributes e-liquid products, which are regulated as tobacco products under the FD&C Act. The primary violation identified is the manufacturing, selling, and/or distributing of VAPERZ Blue Raspberry 12mg 60ml e-liquid without the required premarket marketing authorization order. This product is considered a "new tobacco product" as it was not commercially marketed before February 15, 2007, and lacks FDA authorization under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the failure to provide required notice under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The firm, a registered manufacturer with over 7,100 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative sales and a plan for future compliance.