FDA WARNING_LETTER - KMG-IMPORTS, LLC - April 03, 2025

On April 3, 2025, the FDA issued a Warning Letter to KMG-IMPORTS, LLC, following a review of inspection records. The FDA determined that KMG-IMPORTS, LLC sells and/or distributes Electronic Nicotine Delivery System (ENDS) products, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "XTRON FRUIT FUSION 5% NICSALT 22ML" was cited. This product is considered a new tobacco product because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

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).

KMG-IMPORTS, LLC is required to submit a written response within 15 working days, detailing actions taken to address the violations, including discontinuing the sale/distribution of the non-compliant products and outlining a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or