Liquid Nics LLC – FDA Warning Letter, Oct 31, 2024

On October 31, 2024, the FDA issued a Warning Letter to Liquid Nics LLC, identifying that the company manufactures, sells, and/or distributes e-liquid products, which are considered tobacco products under the FD&C Act. The FDA determined that Liquid Nics Cool Wave 18mg/ml e-liquid product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The product lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act and is not otherwise exempt. Consequently, this product is deemed 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 FDA requires Liquid Nics LLC to submit a written response within 15 working days from the date of receipt. The response must detail actions taken to address the violations, including dates of discontinued sales/distribution of the violative products, and a plan for maintaining compliance with the FD&C Act. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.