On May 7, 2020, the Food and Drug Administration (FDA) provided an update on the agency’s efforts to control companies and individuals that are taking advantage of or exploiting the fear among citizens during the COVID-19 pandemic. As the number of scammers on the internet selling fraudulent medical products continues to rise, the FDA has taken steps to protect against them. The FDA is continuing to shut down sellers of unapproved medical products that claim to mitigate, treat, prevent, cure, or diagnose the coronavirus.
According to FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, the agency seeks to ensure there is adequate access to critical medical products across the country. Therefore, it is crucial that they continue to find and prevent the sale of products that might be harmful to the public.
The FDA stated that Americans can rest assured knowing that the agency is investigating, examining, and reviewing potentially fraudulent medical products both within domestic commerce and at the borders. Their goal is to ensure that the supplies and resources that reach the frontline workers are appropriate to treat COVID-19. McMeekin stated that the FDA takes their responsibility to detect fraudulent, illegitimate, or counterfeit medical products very seriously, and they will take action as needed.
Here are some key highlights of the FDA’s actions:
The FDA is sending out warning letters and taking legal action against companies or individuals making false internet claims, including COVID-19 treatment, prevention, or cures.
So far, the FDA has sent out 42 warning letters to companies that are making non-credible coronavirus claims. Warning letters typically are issued to firms for selling fraudulent products that include claims to mitigate, treat, prevent, or cure the coronavirus. The FDA uses these letters to exercise its authority to protect consumers from businesses that are selling unapproved products or making misleading claims. Along with warning letters, the FDA may also seize or issue an injection for firms or individuals who violate the law. You can report a website to the FDA that is selling human or animal drugs, biological products, foods, medical devices, cosmetics or dietary supplements illegally.
For example, one seller of a fraudulent chlorine dioxide product (medically equivalent to bleach) stated that their product was a “Miracle Mineral Solution” or MMS as a treatment for COVID-19.
The seller refused to take down the false claims. This was concerning to the FDA because they had received reports of people experiencing serious adverse results due to taking certain chlorine dioxide products. This included respiratory failure, life-threatening low blood pressure, QT prolongation and acute liver failure. Therefore, a federal court issued the seller a preliminary injunction that required the seller to immediately stop selling its potentially dangerous and unproven product.
The FDA is also enforcing its Operation Quack Hack. It has discovered hundreds of products in just a few short weeks that contain fraudulent testing kits, drugs, and personal protective equipment (PPE) that are being sold online with false claims. The FDA stated that they will continue to work with domain name registrars, online marketplaces, social media websites, and payment processors to remove any products and platforms making fraudulent claims. This includes any claims that a particular product or service treats, cures, prevents, or mitigates the coronavirus. The FDA notes that there is currently no treatment or cure for COVID-19 and warns people against taking any product that makes these claims.
Currently, the FDA has sent out hundreds of abuse complaints to internet marketplaces and domain name registrars that are making false claims and capitalizing on the public’s fear of COVID-19. Most companies voluntarily remove their claims, but some are not as cooperative. The FDA will continue to monitor the internet for fraudulent products and websites created by people who are trying to profit off the global pandemic. The agency encourages the public to report and potentially fraudulent medical companies making claims to cure or prevent the coronavirus.
The FDA strives to keep a number of unproven products out of the country. For example, the agency recently investigated and intercepted a case that included treatment kits for COVID-19, which were mislabeled and offered for import. With the help of international and domestic law encouragement, special agents with the FDA’s office of criminal investigations were able to locate a British man seeking profit among the pandemic before he had a chance to injure anyone with his false product.
According to a report put out by the United States Department of Justice, Frank Richard Ludlow, 59, of West Sussex, United Kingdom, was charged with introducing misbranded drugs into the public. The offense carries a maximum sentence of three years in federal prison. Ludlow marked his so-called treatment kits as “Trinity COVID-19 SARS Antipathogenic Treatment” kits.” The kits were not approved by the FDA or for any other use.
The alleged cure kit contained vitamin C, an enzyme mix, hydrogen peroxide, and potassium thiocyanate. Consumers were told to add the packet to 18 ounces of water, pray, drink half of the solution, take a probiotic with bee pollen, and then drink the rest of the mixture. Ludlow sold these kits for $50 each. He gave many of them away for free while he charged up to $200 for others. Between 300 and 400 of these kits were intercepted before they were able to be distributed.
According to United States attorney Nick Hanna, people who make up “cures” for the coronavirus, which currently has no cure, put lives at risk by peddling unapproved drugs. Hanna stated that they are aggressively investigating all criminal activity associated with the current COVID-19 outbreak. He stated that anyone attempting to cheat the public and possibly cause harm will face severe penalties.
The FDA realizes that they have their work cut out for them until the curve is flattened, and even after. They plan to carry out the agency’s goal of protecting the public from those who seek profit during the COVID-19 outbreak by selling false products. The FDA strives to prevent unlawful and possibly harmful non-regulated products from being distributed or entering in our country.
The FDA is an agency within the United States Department of Health and Human Services. Their job is to protect public health by ensuring the security, effectiveness, and safety of both human and animal drugs, vaccines, and other products intended for use, including medical equipment. The FDA is also responsible for the security and safety of the food supply, cosmetics, tobacco product regulation, and products that give off electronic radiation. The FDA also monitors dietary supplements to ensure that no claims are made in regards to disease treatments or prevention.