FDA Targets COVID-19 Claims Over Stem Cell, Dental Products

By Emily Field
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Law360 (November 20, 2020, 10:23 PM EST) -- The U.S. Food and Drug Administration has issued more warnings over claims that products could prevent or treat COVID-19, this time targeting stem cell products and dental rinses.

The letters, dated Nov. 18 and posted on Thursday and Friday, were sent to Vibrant Health Care Inc. and Pro Breath MD, which does business as OraCare, over their respective stem cell and dental care products marketed as treatments and cures for the novel coronavirus. The FDA warned the companies that their promotional efforts were violations of the Federal Food, Drug and Cosmetic Act because their products were unapproved new drugs.

"We request that you take immediate action to cease the marketing or sale of any such unlicensed, unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis or cure of COVID-19," the FDA said in the letters.

The FDA cited claims on Pro Health MD's website that its OraCare rinse is 99.99% effective against the coronavirus and that it kills the virus in as little as one minute.

The company also stated "OraCare is the BEST product for pre-rinsing because OraCare's active ingredient chlorine dioxide (ClO2) kills bacteria, viruses, fungi, and breaks up biofilm through the process of oxidation ... It is safe and effective," according to the FDA.

As for Vibrant Care, it made a Facebook post stating stem cells are proving to be effective in treating coronavirus patients and that stem cell therapy can help build up the immune system, the FDA wrote in the letters.

"We also note that you market your umbilical cord-derived cellular product for numerous other diseases or conditions, such as diabetes, ulcerative colitis, multiple sclerosis, Crohn's disease, lupus, inflammatory bile disease and asthma," the FDA said.

The FDA gave the companies 48 hours to respond to the letters. The claims had been pulled from Vibrant Care's website at www.vibranthealthcare.org and replaced with a post stating "Vibrant Health Care does not offer any products or treatments that can mitigate, prevent, treat, diagnose or cure COVID-19. If you are experiencing COVID-19 symptoms, please contact your primary care physician or local hospital."

Claims that OraCare killed 99.99% of the coronavirus were still on Pro Health MD's site as of Friday evening.

The FDA as well as the Federal Trade Commission have been issuing warnings over COVID-19 claims. The FDA has sent out 137 warning letters targeting companies making COVID-19 claims since the start of the pandemic.

At the beginning of the pandemic in April, the federal agencies told far-right conspiracy theorist Alex Jones and his online InfoWars store to stop selling products falsely touted as cures or treatments for the novel coronavirus, following a similar directive from the New York attorney general.

The FDA said it had checked the InfoWars website on April 6 and viewed videos boosting SuperSilver and Superblue products, such as toothpaste, as cures and treatments for COVID-19.

Representatives for the companies didn't immediately respond to requests for comment on Friday.

--Editing by Janice Carter Brown.

For a reprint of this article, please contact reprints@law360.com.

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