D&C Beckley, Inc d/b/a Kickin’ Ash Vapors – FDA Warning Letter, Aug 12, 2021

The FDA issued a Warning Letter to D&C Beckley, Inc d/b/a Kickin’ Ash Vapors, identifying violations related to the manufacture and distribution of e-liquid products. The FDA determined that the firm's KICKIN’ ASH VAPORS Watermelon 6 mg e-liquid product is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

The product was found to be adulterated under section 902(6)(A) of the FD&C Act as it lacks the required FDA marketing authorization order. It is also misbranded under section 903(a)(6) of the FD&C Act because the necessary notice or information under section 905(j) was not provided. These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The firm, a registered manufacturer with over 200 listed products, is responsible for ensuring compliance across all sales channels. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates of violative sales, and a plan for future compliance.