HotHead Vapor – FDA Warning Letter, Jan 27, 2022

The FDA issued a Warning Letter to HotHead Vapor, specifically Ms. Wade, for manufacturing and distributing unapproved new tobacco products. The Center for Tobacco Products determined that HotHead Vapor's e-liquid products, including "HOTHEAD VAPOR Caustic 3 Nic" and "HOTHEAD VAPOR Bloody Pig 3 Nic," are tobacco products under the FD&C Act. These products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided per section 905(j). The failure to provide such reports is a prohibited act under section 301(p). The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.