By: Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs, and Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs
Throughout the pandemic, the U.S. Food and Drug Administration has found many nefarious actors seeking to exploit consumers during the pandemic by selling unproven medical products often with fraudulent claims. The emergence of fraudulent medical products is a common phenomenon during crisis situations. For example, in 2013, the FDA issued 10 warning letters to firms selling unproven medical products with false or misleading claims to protect against influenza. In 2014, 7 warning letters were issued for unproven and fraudulent Ebola products.
The FDA is well-equipped to rapidly identify and thwart medical product scams to protect consumers. The Office of Criminal Investigations (OCI), the Office of Enforcement and Import Operations (OEIO) and the Health Fraud Branch within the Office of Regulatory Affairs (ORA) work collaboratively with colleagues in the FDA’s medical product centers and the Office of Chief Counsel as well as other government agencies such as the U.S. Customs and Border Protection and the U.S. Department of Justice.
Once COVID-19 reached the U.S., the FDA received complaints from U.S. consumers about unproven cures, illegitimate test kits, and substandard or counterfeit respirators being offered for sale on the internet, and the agency identified thousands of new “high-risk” internet domain names that were registered in early 2020. To proactively identify and neutralize these threats to consumers, the FDA launched Operation Quack Hack in March 2020.
Operation Quack Hack leverages agency expertise and advanced analytics to protect consumers from fraudulent medical products during the COVID-19 pandemic. Building upon our previous experience with illegal online pharmacies, a team of consumer safety officers, special agents and intelligence analysts triage incoming complaints about fraudulent and unproven medical products. Where appropriate, complaints are sent to other agencies or to FDA centers for additional review, or are referred for a warning letter, civil action, or criminal investigation. In some cases, following a preliminary investigation, the Operation Quack Hack team sends an abuse complaint to the domain name registrars or a report to online marketplaces. These abuse complaints and reports are intended to notify companies that may not have been aware that their platforms were being used to sell an unapproved, unauthorized, or uncleared medical product during the COVID-19 pandemic.
As of June 2020, the FDA has identified more than 700 fraudulent and unproven medical products related to COVID-19. The Operation Quack Hack team has reviewed thousands of websites, social media posts, and online marketplace listings, resulting in over 90 warning letters to sellers, more than 150 reports sent to online marketplaces, and more than 250 abuse complaints sent to domain registrars to date. Operation Quack Hack initiatives have led domain registrars to investigate and take down numerous websites illegally selling unproven products and retailers to remove hundreds of unlawful products from the marketplace.
The website “https://corona-cure.com” sold a nasal spray for the prevention of COVID-19 infection. Operation Quack Hack detected the website, identified evidence that it sold products with false or misleading COVID-19 claims, and the FDA issued a warning letter to the vendor requesting corrective action within 48 hours, leading the website to be taken down.
Another example is the “Covid-19 Rapid Test Kit,” which Medakit Ltd.’s website stated is a rapid COVID-19 test kit that could be used at home and would provide results within 15 minutes. The FDA observed that the seller’s website offered a fraudulent and unproven product and sent a warning letter to the seller.
Effective consumer protection also requires proactive consumer education. The FDA has developed a number of resources on steps consumers can take to protect themselves from fraud. The agency has also launched several new communication initiatives, such as the podcast FDA Insight to help inform consumers about the latest medical and scientific developments. Finally, the FDA encourages patients and health care providers to report websites and others that may be illegally selling fraudulent or unproven products to the agency using a portal on the FDA website, which is available in both English and Spanish.
From monitoring the supply chain, to acting to minimize drug shortages, to overseeing the food supply to reduce the risk of illness, the FDA is committed to promoting consumer safety during COVID-19. The FDA’s consumer protection work is a cornerstone of our mission and a critical component of our pandemic response efforts.