It has been a wild past two years trying to figure out what products can mitigate, treat, diagnose or even cure Coronavirus Disease (COVID-19) in the United States and across the globe. The United States Food and Drug Administration (FDA) has issued many warning letters to companies that have been selling fraudulent products with claims of just that.

The FDA has been actively monitoring for marketed products with fraudulent claims of COVID-19 treatment and prevention. The FDA is focused on demonstrating its authority to protect consumers from companies attempting to sell unapproved products and making false claims on consumer goods. These products consist of but are not limited to COVID-19 test kits, sanitizers, teas, and various cold and flu products.

Since the start of the COVID-19 outbreak, there have been hundreds of companies and individuals with these claims. Currently, less than 50 percent of the firms claiming to treat, cure or eliminate COVID-19 are in corrective status with the FDA. Once in corrective status, the firm has removed any statement on products that were originally claiming to cure or were sold for COVID-19 prevention.

Throughout the FDA issuing warning letter, seizures, injunctions, or criminal prosecutions to individuals and companies in violation of the law the COVID-19 claims have decreased each year. If your company needs assistance with ensuring that you are properly complying with the regulations for your medical product, EMMA International can assist. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.


[1] FDA (February 2022) Fraudulent Coronavirus Disease 2019 (COVID-19) Products, Retrieved 3/21/2022 from https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

More Resources

Pattern Recognition as a Quality Superpower

Pattern Recognition as a Quality Superpower

There are always new ways and reasons to apply pattern recognition to quality improvement. Better ensuring patient outcomes in health care facilities and improving accuracy for medical diagnoses are two such frontiers.
Record Control for a Regulated World

Record Control for a Regulated World

In a regulated industry, the prevailing posture of regulatory representatives, in my experience, has been “Show me proof.” In fact, the philosophy I’ve heard repeated by regulators is “If it wasn’t documented, it didn’t happen.”
EU MDR SSCP’s: The Importance of Readability

EU MDR SSCP’s: The Importance of Readability

Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.

Ready to learn more about working with us?

Pin It on Pinterest

Share This