FDA WARNING_LETTER - Vapor Vapes Inc. - March 30, 2022

The FDA issued a Warning Letter to Vapor Vapes Inc. on March 30, 2022, after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically VAPOR VAPES E-LIQUID Flavorless 12mg/250ml and VAPOR VAPES E-LIQUID Fruity Chewz 6mg/250ml, without the required marketing authorization. These products are classified as "new tobacco products" under section 910(a) of the FD&C Act, as they were not commercially marketed before February 15, 2007, and lack an FDA marketing authorization order under section 910(c)(1)(A)(i). 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 sections 301(k) for holding adulterated/misbranded products for sale and 301(p) for failing to provide required reports. Vapor Vapes Inc. must submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative sales/distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.