Vape King Inc. – FDA Warning Letter, Dec 15, 2022

The FDA issued a Warning Letter to Vape King Inc. after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically "Vape King Blue Raspberry 3mg e-liquid product," for commercial distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction and compliance requirements.

The primary violation identified is that the "Vape King Blue Raspberry 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 premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The failure to provide a required report under section 905(j) is also a prohibited act.

The FDA requires Vape King Inc. to submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.