By: Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs
It has been said that there is good fishing in troubled waters and that has been the case with fraudsters seeking to profit from anxiety and fears associated with COVID-19. Accordingly, the U.S. Food and Drug Administration is on the lookout for charlatans seeking to profit from the pandemic.
Public health protection for consumers is the hallmark of our mission, and the FDA remains vigilant to protect consumers from fraud, which undermines public confidence in legitimate COVID-19 vaccine efforts. While vaccine distribution is underway throughout the country, schemes and unsavory efforts to mislead and scam the American public are plentiful.
The FDA is well-equipped to identify and thwart medical product scams. The Office of Regulatory Affairs’ Health Fraud Branch, the Office of Criminal Investigations (OCI), and the Office of Enforcement and Import Operations work collaboratively with colleagues in the FDA’s medical product centers, the FDA’s Office of Chief Counsel, and the HHS Office of Minority Health, as well as other government agencies such as U.S. Customs and Border Protection and the U.S. Department of Justice.
This united federal effort has enabled the agency to minimize the impact of fraud on consumers. For example, OCI agents, working with partner agencies, quickly investigated, charged, and obtained guilty pleas from a Georgia man and his company for selling misbranded drugs advertised to treat COVID-19. Like the snake-oil salesmen of old, the suspect in this case said his $19 “Immune Shot” could “LOWER your risk of COVID-19 by nearly 50%.” The suspect targeted individuals aged 50 and older with sales pitches, including company website statements such as “The NEXT FIVE MINUTES could save your life,” “… Immune Shot could be the most important formula in the WORLD right now due to the new pandemic,” “Immune Shot is Not a Luxury, It is a Necessity Right Now,” “Point Blank, if YOU Leave, YOU are at Risk,” and “Is Your Life Worth $19? Seriously, Is It?”
In another case, an OCI agent went undercover to arrest a fraudster who was posing as a biotech expert. The suspect in this case claimed to have created an injectable COVID-19 vaccine that he offered to inject in customers for $400-$1,000 each. In early March 2020, undercover OCI agents contacted the suspect through social media posts. The suspect claimed he had developed and administered vaccines for cancer and COVID-19. Around the same time, the state of Washington Attorney General issued a cease and desist letter, telling the suspect to stop making claims and offering his “vaccine” for COVID-19. Undeterred, the suspect indicated to undercover agents the warning had just increased demand for his injections, which he now called an “immunogen” instead of a vaccine. Despite entering a consent decree with the state of Washington to stop selling his purported vaccines, the suspect continued to communicate with the undercover OCI agent and traveled to Idaho to “vaccinate” the agent, where he was arrested.
The agency is also finding tea products claiming to deliver the same benefits as an authorized COVID-19 vaccine. For example, the FDA issued a warning letter in January to a firm selling “Corona Destroyer Tea,” which the firm claimed was formulated for prevention of COVID-19. The agency issued another warning letter to a company marketing a product that the company claimed was an “anti-COVID herbal inoculation” and a part of “ongoing clinical research on effectiveness against COVID-19.” These unproven products have not been evaluated by the FDA for safety and effectiveness for the prevention or treatment of COVID-19.
Unproven products purporting to prevent or treat COVID-19, made from unknown substances under unknown conditions, present significant health risks in and of themselves. They can also lead consumers to make lifestyle choices that increase their risk of infection with COVID-19, or to delay or stop appropriate medical treatment.
Consumers should know the COVID-19 vaccines that the FDA has authorized under Emergency Use Authorization cannot be sold online. Legitimate COVID-19 vaccines are being distributed for free. Unfortunately, the agency is aware of reports of unauthorized websites and listings on online marketplaces purportedly offering COVID-19 vaccines for sale. When such online listings are found by or reported to the FDA, the agency notifies the online marketplaces, who can then remove the listings. We are also aware of emails sent to consumers featuring the FDA logo, advising consumers to call a phone number to schedule a vaccination. If consumers are contacted directly by someone who says they are from the FDA about a COVID-19 vaccine appointment, it is a scam.
The FDA’s dedicated COVID-19 Fraudulent Products Task Force continues to monitor the market, including online, for fraudulent COVID-19 products, and the Operation Quack Hack initiative continues to leverage agency expertise and advanced analytics, resulting in the removal of hundreds of unlawful products from the marketplace. To date, the agency has uncovered nearly 1,300 fraudulent products, sent more than 160 warning letters, issued more than 270 abuse complaints to domain registrars, and sent more than 290 requests to various marketplaces to remove listings for fraudulent COVID-19 products.
The FDA will continue working with its state and federal partners to take appropriate action against bad actors who prey upon people seeking a COVID-19 vaccine in the midst of this global pandemic. The agency has gone to great lengths to ensure that the authorized vaccines available to the public are safe and effective.
The FDA has developed a number of resources on steps consumers can take to protect themselves from fraud. In addition, the agency has several new communication initiatives to help inform consumers about the latest medical and scientific developments. And, on March 4, the agency will be participating in a twitter chat in English (#SlamTheScam) and Spanish (#OjoConLasEstafas) to alert the public about fraud schemes related to COVID-19.
The FDA needs your help to combat fraud and misleading claims. This ‘National Consumer Protection Week,’ we encourage consumers and health care providers to report websites and individuals suspected of selling fraudulent or unapproved and unauthorized products. Reports can be made by the public using a portal on the FDA website, which is available in both English and Spanish. Protecting consumers during COVID-19, and at all times, is a cornerstone of our public health mission.