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 for manufacturing and distributing an e-liquid product without required premarket authorization. The FDA determined that the "Kickin’ Ash Vapors Cinnamon Danish 3mg e-liquid product" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

Under sections 910(a) and 910(c)(1)(A)(i) of the FD&C Act, new tobacco products require a marketing authorization order or an exemption (e.g., substantial equivalence). The identified e-liquid product lacks this authorization, rendering 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 under section 301(p).

The FDA emphasized that the firm, a registered manufacturer with over 200 listed products, is responsible for ensuring all its tobacco products comply with the FD&C Act. Failure to correct these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuation