FDA WARNING_LETTER - Staccato Ventures LLC d/b/a Carolina Vape Kings - September 08, 2022

The FDA issued a Warning Letter to Staccato Ventures LLC d/b/a Carolina Vape Kings on September 8, 2022, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that "THE VAPIN’ SON Pimp Juice 6% 60ml" e-liquid is a "new tobacco product" as defined by section 910(a) of the FD&C Act, meaning it was not commercially marketed in the U.S. as of February 15, 2007.

The product is deemed adulterated under section 902(6)(A) of the FD&C Act because it lacks the necessary FDA marketing authorization order under section 910(c)(1)(A)(i) and is not otherwise exempt. It is also misbranded under section 903(a)(6) for failing to provide required notice or information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for violative sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.