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

Source: https://www.globalkeysolutions.net/records/warning_letter/ardt-sales-llc-dba-zenith-e-juice/2c38981d-ca9e-42e4-8da2-9f3d0f58d77b

> FDA WARNING_LETTER for ARDT Sales, LLC d/b/a Zenith E-Juice on August 19, 2025. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: ARDT Sales, LLC d/b/a Zenith E-Juice
- Inspection Date: 2025-08-19
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2019-06-04](https://www.globalkeysolutions.net/records/warning_letter/ardt-sales-llc-dba-zenith-e-juice/7ffaf87e-2f36-4ae7-abe7-70acf9428cc8)

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/john-e-verbeten/80be3640-a657-41ff-92c0-f6178bd12378)

Company: https://www.globalkeysolutions.net/companies/ardt-sales-llc-dba-zenith-e-juice/c2891173-0d2e-4f7c-9136-c4a6f1ce9fac

Office: https://www.globalkeysolutions.net/offices/center-for-tobacco-products/65f73cae-ef6f-4e9f-a311-a111daa67374