FDA WARNING_LETTER - Vape King, Inc - November 03, 2022

The FDA issued a Warning Letter to Vape King, Inc. on November 3, 2022, following a review of submissions and inspection records. The FDA determined that Vape King, Inc. manufactures and distributes "Delightful e-liquid products" for commercial distribution in the United States. These e-liquid products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is that these "Delightful e-liquid products" are "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. 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 as required by section 905(j). The failure to provide such a report is also a prohibited act under section 301(p).

The FDA requires Vape King, Inc. to submit a written response within 15 working days detailing actions taken to address these violations, including dates of discontinued sales/distribution and a plan for maintaining compliance. Failure to comply may result in regulatory actions