FDA WARNING_LETTER - IT DISTRIBUTIONS LLC - December 01, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to KMT Distribution LLC on December 4, 2025, concerning its sale and distribution of e-liquid products in the United States. The FDA"s review of records indicated that KMT Distribution LLC is marketing "new tobacco products," specifically identifying "MRKTPLCE ELIQUID Thai Apple Melon Razz 3MG 100ML," without the necessary premarket authorization.

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), e-liquid products, including those containing nicotine from any source, fall under FDA jurisdiction. The FD&C Act requires that "new tobacco products"—defined as those not commercially marketed in the U.S. as of February 15, 2007—must have an FDA marketing authorization order to be legally sold. The FDA found that KMT Distribution LLC"s product lacked this essential authorization, consequently rendering it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

KMT Distribution LLC is required to submit a written response within 15 working days. This response must detail the actions taken to address these violations, including the dates on which sales and distribution of the non-compliant products ceased, and outline the company"s plan for maintaining ongoing compliance with the FD&C Act. Failure to comply may lead to regulatory actions such as civil money penalties, product seizure, or injunctions.