FDA WARNING_LETTER - Vapor Cigs LLC - March 12, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Gregory Carr of Vapor Cigs LLC after reviewing their website, http://vaporcigsllc.com. The FDA determined that the firm manufactures and offers for sale e-liquid products, specifically Vapor Cigs LLC Sharks Blood and Vapor Cigs LLC Watermelon, which are classified as "new tobacco products" under section 201(rr) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and therefore require premarket authorization under section 910(a) of the FD&C Act. The firm failed to obtain the necessary FDA marketing authorization orders under section 910(c)(1)(A)(i) for these products. Consequently, these e-liquid products are deemed adulterated under section 902(6)(A) of the FD&C Act 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 FDA emphasized the firm's responsibility, as a registered manufacturer with numerous products, to ensure compliance. Vapor Cigs LLC must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and advertising, and outlining a plan for maintaining compliance. Failure to address these violations could lead to regulatory actions such as civil money penalties, seizure, or injunction.