H2 Beverages, Inc.

Warning LetterClosed

Kurt H. Ruppman, Sr. President / Chief Executive Officer H2 Beverages, Inc. 1601 Summit Ave Ste 100 Plano , TX 75074-8109 United StatesIssued Jun 14, 2022Division of Human and Animal Food Operations West III

View Letter

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

Violations4

Issue DateJun 14, 2022

Product TypeDrugs

StatusClosed

Closeout LetterDec 14, 2023

Letter Details

Firm: H2 Beverages, Inc.
Location: Kurt H. Ruppman, Sr. President / Chief Executive Officer H2 Beverages, Inc. 1601 Summit Ave Ste 100 Plano , TX 75074-8109 United States
FEI Number: N/A
Country: United States
Issue Date: June 14, 2022
Issuing Office: Division of Human and Animal Food Operations West III
Product Type: Drugs
Status: Closed
Closeout Letter: December 14, 2023

Summary

H2 Beverages, Inc. was warned for marketing unapproved drug products—specifically "Hydro Shot," "Silver Bullet Green Tea with Zinc," and "Hydro Brew Unsweetened Green Tea"—with disease claims including COVID-19 mitigation, prevention, treatment, and cure on their website and social media. The company violated the Federal Food, Drug, and Cosmetic Act by making therapeutic claims that established these hydrogen-infused water beverages as drugs without FDA approval or proper drug registration. The violations were identified during an FDA inspection in November 2021 and subsequent review of the company's website and Facebook marketing materials in March 2022.

H2 Beverages, Inc. FDA Warning Letter, June 14, 2022