FDA WARNING_LETTER - AK Wholesale Inc.

The FDA issued a Warning Letter to AK Wholesale Inc., located in Bensenville, IL, on September 25, 2025, following an inspection by the Center for Tobacco Products. The inspection revealed that AK Wholesale Inc. sells and distributes electronic nicotine delivery system (ENDS) products in the U.S. without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FD&C Act, as amended by the Consolidated Appropriations Act, 2022, requires that all tobacco products, including those containing nicotine from any source, must comply with FDA regulations. Specifically, new tobacco products, defined as those not marketed in the U.S. before February 15, 2007, require a marketing authorization order. The product "DOOZY ICE CUBE BLUEBERRY ICE 50 MG/ML 20 ML" was identified as lacking this authorization, rendering it adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The FDA mandates that AK Wholesale Inc. take immediate corrective actions to comply with the FD&C Act. The company must submit a written response within 15 working days detailing the steps taken to address the violations, including cessation of the sale and distribution of the non-compliant products. Failure to comply may result in enforcement actions such as civil penalties, product seizure, or injunctions. The company is advised to ensure all products and related advertising meet regulatory requirements to avoid further legal consequences.