FDA WARNING_LETTER - Paradigm - June 03, 2025

On May 29, 2025, the FDA Center for Tobacco Products issued a Warning Letter to Savant Industries, LLC, d/b/a Paradigm Distribution, for manufacturing, selling, and/or distributing e-liquid products without required marketing authorization. The FDA determined that e-liquid products, including "PARADIGM Main Line 30ml – WICKED BERRY 24mg," are "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order.

These products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization or substantial equivalence reports. The letter emphasizes that products containing nicotine from any source are subject to FDA jurisdiction since the March 15, 2022, amendment to the FD&C Act.

Savant Industries must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales/distribution of non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.