FDA Issuing Warning Letters to Companies Selling Fraudulent COVID-19 Treatments

Nearly a year into the COVID-19 pandemic, the U.S. Food & Drug Administration (FDA) continues working to protect consumers from companies making false statements about their products – those claiming certain supplements and drugs can mitigate, treat or prevent the novel coronavirus.

One of the ways the FDA may exercise its authority is through public “warning letters” to these companies, up to and including seeking criminal prosecution against parties who continue to willfully violate FDA regulations. As of December 2020, the FDA has issued 151 warning letters against various firms and pharmaceutical companies for marketing products with fraudulent COVID-19 claims.

What is an FDA warning letter?

A warning letter is a formal notification sent to a company from the FDA that identifies regulatory violations. The warning letter is an escalation from any concerns first noted by FDA inspectors, and issued by senior FDA officials after reviewing an inspector’s report. Common causes for issuing an FDA warning letter for products include:

• Non-compliant procedures
• Failure to follow procedures
• Failure to document proof of adhering to regulation and procedures

The last point is important for consumers. A company can’t just say a product is safe and it works. It has to have hard, scientific proof. If it claims something without that proof, and you’re harmed as a result, you likely have grounds for a product liability case.

FDA warning letters, because of their importance, are typically delivered by hand and require a written response within 15 days. Depending upon the severity of the infraction or circumstances, the FDA has the authority to cut this deadline shorter and force the offending company to rectify their violations immediately.

Further, FDA warning letters are completely public. The FDA’s website currently houses over 3,400 warning letters.

Some of the latest fraudulent COVID-19 products on the FDA warning letter list include:

• health, Vitamins, quercetin, zinc and omega-3 products
• Indigenous Products, Mineral products
• Paradigm RE LLC, “Thymosin Alpha 1”
• Rat’s Army, “VIRUS BIOSHIELD”
• Heavenly Natural Products, C60 (Carbon 60) and colloidal silver products, including “AVOCADO C60 ANTI-VIRAL COMBO – VIRUS PREVENTION”
• Avazo-Healthcare, LLC, COVID-19 test kit products and CBD products
• Industry Lab Diagnostic Partners, “COVID-19 Testing Kit”
• Vibrant Health Care, Inc., Umbilical cord derived cellular product

The FDA calls their movement to crack down on fraudulent and dangerous COVID-19 claims “Operation Quack Hack.”

If you or a loved one suffered injury from a dangerous or defective product, talk to the product liability attorneys at McNicholas & McNicholas today. We hold negligent and irresponsible companies accountable for the harm they cause to consumers. To schedule your free case evaluation with an experienced Los Angeles attorney, call 310-474-1582, or reach out to us through our contact page to tell us your story.

Please note that this blog is not to be construed as legal advice. Because every case is fact-specific, you should consult directly with an attorney to obtain legal advice specific to your situation.