FDA Blasts Fake COVID-19 Treatments in Warning Letters

The FDA has issued a flood of warning letters during the pandemic to crack down on marketers of sham COVID-19 treatments.

As of Nov. 17, the agency said it had identified more than 1,200 “fraudulent and unproven medical products related to COVID-19.”

Under Operation Quack Hack, which began in March, agency investigators have “reviewed thousands of websites, social media posts and online marketplace listings, resulting in over 132 warning letters to sellers,” the agency said.

In two of the most recent warning letters, the agency zeroed in on claims by Bridgeport, W.Va.-based Pro Breath MD, and Scottsdale, Ariz.-based Vibrant Health Care. The letters noted that the FDA “is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose or cure COVID-19 in people.”

Pro Breath, which also does business as Dentist Select and OraCare, was cited for promoting its OraCare Health Rinse and OraCare Operatory Pre-Rinsing Set as COVID-19 treatments. The company’s website claimed, for example, that in a study, OraCare Rinse was found “greater than 99.99 percent effective against human coronavirus with no toxic effects on tissue.”

Vibrant was cited for offering “an umbilical cord-derived cellular product in the United States to mitigate, prevent, treat, diagnose or cure COVID-19 in people,” which the FDA deems an unapproved new drug, as well as an unapproved biological product for which an approved biologics license application would be required.

The FDA states that Vibrant made claims on its website, YouTube channel and Facebook page that “stem cells are proving to be effective in treating critically ill coronavirus patients. Stem cell therapy can also help build up the immune system and fortify lungs against viruses.”

The FDA asked both companies to stop making such claims and gave them 48 hours to describe the steps taken to correct the violations.

Neither company responded to requests for comment.

Read the two warning letters here: www.fdanews.com/11-24-20-WarningLetters.pdf. — Martin Berman-Gorvine