FDA WARNING_LETTER - H2 Beverages, Inc. - November 10, 2021

On June 14, 2022, the FDA issued a Warning Letter to H2 Bev regarding their hydrogen-infused water beverages: “Hydro Shot,” “Silver Bullet Green Tea with Zinc,” and “Hydro Brew Unsweetened Green Tea.” This followed an inspection of their Plano, TX facility from November 8-10, 2021, and a review of their website and social media in March 2022.

The FDA determined that the products are unapproved new drugs and misbranded drugs under the FD&C Act. Website claims, including those for COVID-19 mitigation for "Silver Bullet Green Tea with Zinc," establish drug intent. Since the products are not generally recognized as safe and effective for these uses, they are "new drugs" requiring prior FDA approval. They are also misbranded because they lack adequate directions for use by a layperson, as their intended uses are not amenable to self-diagnosis or treatment.

Additionally, the products are misbranded as foods. "Hydro Shot" lacks a common or usual name. All three products fail to include the manufacturer's, packer's, or distributor's name and place of business, and do not list each ingredient by its common or usual name.

H2 Bev must respond within 15 working days, detailing corrective actions and prevention measures, or explain any delays. Failure to comply may result in legal action, including seizure and injunction.