FDA WARNING_LETTER - Kings of Vapor - September 27, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Kings of Vapor, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that Kings of Vapor's e-liquid products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

During an inspection, FDA observed that Kings of Vapor failed to register its manufacturing establishment at 2603 State Road, Cuyahoga Falls, OH 44223, as required by section 905(c) of the FD&C Act. This failure renders the manufactured tobacco products misbranded under section 903(a)(6) and constitutes prohibited acts under sections 301(k) and 301(p).

Additionally, the FDA found that Kings of Vapor's products were not included in a product list as required by section 905(i) of the FD&C Act. This omission also results in the products being misbranded under section 903(a)(6) and constitutes prohibited acts under sections 301(k) and 301(p).

Kings of Vapor is required to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales and a plan for maintaining compliance. Failure to comply may lead to regulatory actions such as civil money penalties, seizure,