FDA WARNING_LETTER - ARDT Sales, LLC d/b/a Zenith E-Juice - August 19, 2025

The FDA"s Center for Tobacco Products issued a warning letter to Ardt Sales, LLC, operating as Zenith E Juice, concerning their e-liquid products sold on the website https://zenithejuice.com. The inspection, which reviewed the company"s online sales practices, identified that products such as Hydra, Draco, and Orion by Zenith E-Juice are being marketed in the U.S. without the necessary premarket authorization. These products are classified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they were not commercially available in the U.S. before February 15, 2007, and lack FDA marketing authorization.

The FD&C Act, amended by the Consolidated Appropriations Act, 2022, extends FDA jurisdiction to all products containing nicotine, regardless of its source. Consequently, Zenith E Juice"s products are deemed adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act due to the absence of a marketing authorization order and failure to provide required product information.

The FDA requires Zenith E Juice to submit a written response within 15 working days, detailing corrective actions taken to address these violations and ensure compliance with the FD&C Act. Potential regulatory actions for non-compliance include civil penalties, product seizure, or injunction. The company is advised to ensure all products and related marketing comply with FDA regulations to avoid enforcement actions.