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FDA News Release

Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID-19 Medical Products

For Immediate Release:

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Today, the U.S. Food and Drug Administration is providing an update on the agency’s efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic. In response to scammers on the internet selling unproven medical products, the FDA has taken – and continues to take – a number of steps to find and stop those selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19.

“While we seek to ensure access to critical medical products, it is imperative that we continue our efforts to find and prevent the sale and distribution of products that may be harmful to the public health. Americans can rest assured that we’re leveraging our experience investigating, examining, and reviewing medical products, both at the border and within domestic commerce, to help ensure that the critical resources reaching the frontlines in the battle against COVID-19 are appropriate,” said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D. “We take seriously our responsibility to determine whether the medical products coming into our country are fraudulent, counterfeit or illegitimate, and take action as needed.”

To date, the FDA has issued 42 warning letters to companies making bogus COVID-19 claims, including one to a seller of fraudulent chlorine dioxide products, equivalent to industrial bleach, frequently referred to as “Miracle Mineral Solution” or “MMS”, as a treatment for COVID-19. After the seller refused to take corrective action, a federal court issued a preliminary injunction requiring the seller to immediately stop distributing its unproven and potentially dangerous product.

Additionally, as part of the FDA’s Operation Quack Hack, in just a few short weeks, the agency has discovered hundreds of such products including fraudulent drugs, testing kits and personal protective equipment (PPE) sold online with unproven claims. We continue to work with online marketplaces, domain name registrars, payment processors and social media websites to remove from their platforms products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19 and to keep those products from reappearing under different names. At this time, the FDA has sent hundreds of abuse complaints to domain name registrars and internet marketplaces, who in most instances, have voluntarily removed the identified postings. We will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic. We encourage anyone aware of suspected fraudulent medical products for COVID-19 to report them to the FDA.

There are a number of examples of unproven products that the FDA is keeping out of the country. Recently, the agency intercepted and investigated a case of mislabeled COVID-19 “treatment kits” offered for import. As a result, Special Agents with the FDA’s Office of Criminal Investigations, with the help of domestic and international law enforcement counterparts in the United Kingdom, led the Department of Justice to bring a criminal complaint against a British man who sought to profit from this pandemic and jeopardize public health.

Until the curve is flattened, and even after, the FDA will continue to carry out the agency’s mission of protecting the health and safety of American consumers and strive to prevent unlawful FDA-regulated products from entering, or being distributed in, domestic commerce.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

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