FDA WARNING_LETTER - HS GLOBAL DISTRIBUTION LLC, d/b/a O&Z WHOLESALE - September 02, 2025

The FDA"s Center for Tobacco Products issued a warning letter to HS Global Distribution LLC, operating as O&Z Wholesale, on August 28, 2025, following an inspection. The company was found to be selling and distributing e-liquid products in the U.S. without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the product "Juice Head Freeze Pineapple Grapefruit 3MG/ML 100mL" was identified as a new tobacco product lacking FDA marketing authorization, rendering it adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.

The regulatory framework requires that all new tobacco products, defined as those not commercially marketed in the U.S. as of February 15, 2007, must have a premarket authorization order. The FDA"s jurisdiction extends to products containing nicotine from any source, as per the amendments to the FD&C Act under the Consolidated Appropriations Act, 2022.

HS Global Distribution LLC is required to submit a written response within 15 working days, detailing actions taken to address the violations and plans to ensure compliance with the FD&C Act. Failure to comply may result in enforcement actions, including civil penalties, seizure, or injunction. The company must ensure all tobacco products and related advertising comply with FDA regulations.