FDA WARNING_LETTER - Staccato Ventures LLC d/b/a Carolina Vape Kings - September 22, 2022

On September 22, 2022, the FDA issued a Warning Letter to Staccato Ventures LLC d/b/a Carolina Vape Kings for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that the e-liquid products, specifically "The Vapin’ Son Bird Blood .6% 60ml" and "The Vapin’ Son King’s Blood .2% 30ml," are "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007.

These products are considered adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) because they lack FDA marketing authorization orders and no notice or information was provided as required by section 905(j). The failure to provide such reports is a prohibited act under section 301(p). The letter emphasizes that all tobacco products, including those containing nicotine from any source, must comply with the FD&C Act. The company must submit a written response within 15 working days detailing actions to address violations, including discontinuing sales and distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.