FDA Issues Misbranding Warning to H2 Beverages

In June, the Food and Drug Administration (FDA) sent a warning letter to H2 Beverages over misleading health claims and misbranded labels of the hydrogen-infused beverages.

The FDA found that the Plano, Texas-based business’s website claimed medical benefits that could not be legally substantiated under various sections of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). All three of H2 Beverages products – Hydro Shot, Hydro Brew Unsweetened Green Tea and Silver Bullet Green Tea with Zinc – also were in violation of improper product labeling under section 403(e)(1) of the FD&C Act, the agency said.

Most were “minor things that have already been addressed” on the website, said H2 President and CEO Kurt Ruppman, Sr.

He said some of the issues with labeling was “picky on some stuff but things that have changed over the years” and the company is in the process of rectifying the problems to meet the FDA standards after consulting with a beverage industry attorney.

H2 products infuse water with molecular hydrogen (two hydrogen atoms that are chemically bonded together separately from the hydrogen atom already present in water) along with nitric oxide. The company claims that their products improve blood oxygen levels in the body and brain as well as act as antioxidants and anti inflammatories.

The FDA letter warned H2 that they must remove language on the website that claims that the anti-inflammatory properties of molecular hydrogen protect against radiation damage, gastrointestinal disorders and stabilize cholesterol levels. The letter also chided against using claims that the products can prevent or treat medical conditions like high blood pressure, heart disease or COVID-19.

Ruppman doesn’t fully agree with having to remove customer testimonials from the website that claim some of the health benefits of his product. Not only that but the impetus for producing the beverage brand comes from his own personal experience.

In 2015, Ruppman suffered a heart attack and drank hydrogen water to help his recovery in learning to walk properly again. He also contracted cancer that required 28 days of radiation and face surgery that, he said, left him looking so bad that he ate Thanksgiving in the other room because he didn’t want to make his family sick.

Ruppman calls himself the poster-child for the health benefits of H2 products.

“I’m overweight, 75 years old, has nine stints in his heart, is a cancer survivor and COVID lasted four or five days and was over,” he said.

For now, nevertheless, the brand has pared down its language on the website by adding a page of links to various medical and scientific studies of molecular hydrogen and nitric oxide. The brand also includes the results of a clinical study by the Corpus Performance Sports Facility in Dallas that determined the possible improvements in Maximal Aerobic Power and Functional Threshold Power and Maximal Oxygen Uptake of people using Hydro Shot.

Ruppman soft launched H2 Beverages in 2016 after he shut down operations of his former beverage brand, True Brew Tea.

The products are only available D2C on the website. Twelve packs of Hydro Shot and Silver Bullet retail for $40 and Hydro Brew 12-packs sell for $29. Ruppman reports that the brand has maintained over 50% reorder rate on the products.

He is confident in the product, and is excited to announce some big news this year about athlete partnerships and evidentiary studies of the efficacy of the beverages’ wellness benefits. He said he wouldn’t be doing this at 75 years old if he didn’t believe in it.

“A lot of years [and] dollars have gone into it. I think I should absolutely have disowned my family for ever talking me into this,” he laughed.