CVM 3, LLC d/b/a Carolina Vapor Mill – FDA Warning Letter, Aug 2, 2022

The FDA issued a Warning Letter to CVM 3, LLC d/b/a Carolina Vapor Mill, stating that their e-liquid products, specifically "V TFN Shine Love Shack 12mg 120ml," are considered tobacco products under the FD&C Act, including those containing nicotine from any source. The FDA determined that this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that the company manufactures, sells, and/or distributes this e-liquid product without the required premarket marketing authorization order from the FDA. This renders the product 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 a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.