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

Source: https://www.keypedia.com/records/warning_letter/hs-global-distribution-llc-dba-oz-wholesale/3a08ad2a-fbe8-4248-a2d7-7c8f5ee17fe4

> FDA WARNING_LETTER for HS GLOBAL DISTRIBUTION LLC, d/b/a O&Z WHOLESALE on September 02, 2025. Product: Tobacco. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: HS GLOBAL DISTRIBUTION LLC, d/b/a O&Z WHOLESALE
- Inspection Date: 2025-09-02
- Product Type: Tobacco
- Office Name: Center for Tobacco Products
- Summary: 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.

## Related Officers

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

Company: https://www.keypedia.com/companies/hs-global-distribution-llc-dba-oz-wholesale/7e0451c1-4ff3-4e6f-84a0-65b7b9bd4c95

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