FDA WARNING_LETTER - Vape King Inc. - August 16, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Vape King Inc. after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically identifying "Vape King Betty Bop 3mg e-liquid product." These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The key violation is that "Vape King Betty Bop 3mg e-liquid product" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007. This product lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j).

These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. Vape King Inc., a registered manufacturer with over 5,100 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/