As Coronavirus Cases Rise, FDA Acts Against Businesses Selling Fraudulent Treatments
Warning letters have gone to several firms that claimed their products prevent or cure COVID-19
Millions of Americans have been staying home in recent weeks to help slow the spread of the novel coronavirus, which causes COVID-19, a fast-moving disease for which there is currently no known cure and no vaccine. That illness has quickly claimed tens of thousands of lives worldwide, leading some people to turn to unproven treatments that purport to be effective against the virus. In response, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have moved rapidly to protect consumers from products that have been falsely advertised to cure or treat the disease.
In March, FDA warned Americans that some people and companies are trying to profit from the pandemic by selling unproven, illegally marketed, and potentially harmful products that fraudulently claim to prevent or treat COVID-19. That same month, the FBI arrested a California man for allegedly selling fake COVID-19 treatments, including a “coronavirus prevention pill” and an injectable “COVID-19 formula vaccine cure.” According to the Justice Department, at least 2 million people had seen YouTube and Instagram videos touting the fraudulent products.
FDA and the FTC have also issued warning letters to several firms for advertising products that falsely tout benefits such as prevention, treatment, mitigation, diagnosis, or a cure for COVID-19. The fraudulent treatments include essential oils, homeopathic drugs, and CBD products—none of which have been evaluated by FDA for safety or effectiveness. Such products risk harming those who take them, FDA said, while prompting consumers to use them in place of lifesaving medical treatments. According to FTC, the agency charged with protecting consumers from deceptive business practices, companies may also be violating federal law by making false or scientifically unconfirmed claims about treating the virus.
FDA issued public safety warnings in March about online retailers selling unauthorized and potentially fraudulent tests that claim to diagnose COVID-19, including at-home tests that rely on patients to collect samples and mail them to a lab for analysis. In its statement, the agency guidance said no home-use test has yet been authorized, which appears to have prompted at least two startup companies that had begun offering such tests to stop distributing them.
More recently, a Chinese company came under scrutiny in April for marketing an at-home COVID-19 test and claiming that it was FDA-approved. Such unproven tests can give people a false sense of security if they receive a negative result that turns out to be incorrect. That could lead the user to unknowingly infect others. The tests also could cause consumers to pursue unnecessary treatments if they receive a false positive result, which could contribute to ongoing medical shortages—from drugs for patients to personal protective equipment for health care workers—that have plagued the COVID-19 response.
The supplement industry also has taken a stand against fraudulent products. In a joint press release issued April 6, a coalition of dietary supplement industry trade associations—the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the United Natural Products Alliance—expressed support for FDA actions against fake coronavirus treatment claims, urging consumers to avoid buying and retailers to refrain from selling such products.
As of April 13, cases of the coronavirus had topped 500,000 in the United States, with more than 22,000 deaths nationwide. As the numbers grow and the pressure on the U.S. health care system intensifies, FDA is working to facilitate the development and authorization of tests and treatments for COVID-19, and to address shortages of essential medical equipment such as respirators and protective gear.
The agency has also worked with more than 240 test developers who plan to submit emergency use authorization requests for tests that detect the virus, and with 125 laboratories that have begun testing under FDA’s public health emergency guidance.
As this work unfolds, FDA and FTC should continue their efforts to monitor the market for false and misleading product claims, act quickly to warn companies that are violating the law, and take steps to file injunctions or seize products if they fail to comply. As COVID-19 continues to take lives throughout the United States, such steps are essential to protect Americans from further harm.
Liz Richardson directs The Pew Charitable Trusts’ health care products program.