May 4, 2020 – An important part of protecting the public health during the COVID-19 pandemic is making sure that the marketing of treatments or remedies that are not approved by the Food and Drug Administration (FDA) to treat the virus is stopped before consumers waste their money or potentially are harmed by these products. Accordingly, the FDA and the Federal Trade Commission (FTC) are proactively identifying fraudulent information about unapproved COVID-19 “cures” and taking enforcement actions against the companies spreading misinformation.
“With intense public worry, no known therapy, and rampant misinformation about COVID-19 spreading on the web and social media, it is all too easy for people to be misled into believing some products on the market have actually been found useful,” said Jon Bigelow, executive director of the Coalition for Healthcare Communication. “We commend the FDA and FTC for tracking and aggressively fighting fraudulent claims.”
Many of the FDA-FTC Warning Letters include boilerplate language about the inherent risks to consumers who purchase misbranded and unapproved new drugs. “Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether,” the enforcement letters state. “We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID‐19.”
In just a matter of weeks, the FDA and the FTC have issued nearly 40 Warning Letters to entities they allege have fraudulently promoted products that claim to treat or prevent COVID-19. The types of products cited in the Warning Letters range from transdermal patches, essential oils and homeopathic drugs that claim to boost the immune system to ward off contracting COVID-19, to copper products, silver-containing products and antiseptics that claim to kill coronaviruses.
Multiple Warning Letters have been sent to different firms that are marketing lopinavir and ritonavir combination products: “While there are FDA-approved versions of lopinavir + ritonavir on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act” for the products being offered by these firms, the enforcement letters state, adding, “In addition, no drug has yet been approved by the FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.”
The FDA and the FTC also have taken even stronger action against fraudulent COVID-19 claims when warranted, FDA Law Blog reported. The FDA recently filed a complaint against the owner of several companies touting silver products as being able to treat or prevent COVID-19; the U.S. District Court for the Central District of California issued a preliminary injunction against a company promoting a supplement that could boost immunity from and combat coronavirus, according the to FTC.
Further, the U.S. Attorney’s Office COVID-19 Fraud Coordinator worked with the FDA’s Office of Criminal Investigations to charge a naturopathic physician with “a felony count of introducing a misbranded drug into interstate commerce” on April 30, according to FDA Law Blog.