WASHINGTON — The Food and Drug Administration (FDA) is warning H2 Beverages Inc. over the sale of unapproved and misbranded hydrogen-infused water beverages as drugs for use in treating or preventing COVID-19 and other diseases.

The agency sent a warning letter last month to the Plano, Texas-based company.

Consumers concerned about COVID-19 should consult with their healthcare provider, the FDA said.

In its letter, the FDA flagged the hydrogen-infused water beverages Hydro Shot, Silver Bullet Green Tea with Zinc and Hydro Brew Unsweetened Green Tea.

The FDA, which inspected H2’s manufacturing and distribution facility in Plano, Texas, in November 2021, also collected copies of product labels and other labeling, and in March it reviewed H2’s website and social media account on Facebook.

“We observed that your product Silver Bullet Green Tea with Zinc is intended to mitigate, prevent, treat, diagnose or cure COVID-19 in people,” the FDA said.

H2 did not respond to CSP requests for comment.

The FDA said that claims on H2’s website establish that Hydro Shot, Silver Bullet Green Tea with Zinc and Hydro Brew Unsweetened Green Tea are drugs under sections of the Federal Food, Drug and Cosmetic Act (FD&C) “because they are intended for use in the cure, mitigation, treatment or prevention of disease.”

Introducing or delivering these products into interstate commerce for such uses violates the FD&C Act, the agency said.

The FDA included examples of some of the website claims that provide evidence that the H2 Beverage products are intended for use as drugs:

For Silver Bullet Green Tea with Zinc:

For Hydro Brew Unsweetened Green Tea:

The FDA said in its letter, “Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are ‘new drugs’ under ... the FD&C Act. ... With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA ... [under] ... the FD&C Act. ... FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.”

The letter continued, “A drug is misbranded under ... the FD&C Act ... if the drug fails to bear adequate directions for its intended use(s). 'Adequate directions for use' means directions under which a layperson can use a drug safely and for the purposes for which it is intended. ... Prescription drugs, as defined [under] ... the FD&C Act ... can only be used safely at the direction and under the supervision of a licensed practitioner.”

The FDA requested that H2 notify it in writing, within 15 working days of receiving the letter, “of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.”

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