GT Hyper Distribution, Inc.

Warning LetterOpen

GT Hyper Distribution, Inc. 700 North Valley Street Anaheim , CA 92801 United StatesIssued Oct 16, 2025Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateOct 16, 2025

Product TypeTobacco

StatusOpen

Letter Details

Firm: GT Hyper Distribution, Inc.
Location: GT Hyper Distribution, Inc. 700 North Valley Street Anaheim , CA 92801 United States
FEI Number: N/A
Country: United States
Issue Date: October 16, 2025
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

GT Hyper Distribution, Inc. was warned for selling and distributing electronic nicotine delivery system (ENDS) products without required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA requirements that "new tobacco products" containing nicotine from any source must obtain marketing authorization before being legally sold in the United States. The Center for Tobacco Products determined the company was operating in violation of section 910 of the FD&C Act and related regulations governing tobacco product distribution.

GT Hyper Distribution, Inc. FDA Warning Letter, October 16, 2025