HotHead Vapor – FDA Warning Letter, Oct 19, 2021

The FDA issued a Warning Letter to HotHead Vapor, identifying their e-liquid products, specifically "HOTHEAD VAPOR Brainz 3 Nic e-liquid," as tobacco products subject to FDA jurisdiction. The letter states that this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the manufacturing, sale, and/or distribution of this e-liquid product without the required premarket marketing authorization order 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) of the FD&C Act, as no required notice or information was provided under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA emphasizes that all new tobacco products without statutory premarket authorization are unlawfully marketed and subject to enforcement, including civil money penalties, seizure, and/or injunction. HotHead Vapor, a registered manufacturer with over 10 listed products, must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and a plan for future compliance.