FDA Warns Consumers About Fraudulent Coronavirus Test Kits

As the novel coronavirus pandemic continues to spread across the country and around the world, the U.S. Food and Drug Administration (FDA) is advising consumers to be aware that certain unscrupulous manufacturers are selling fraudulent COVID-19 test kits and other unapproved products. According to federal health regulators, the only COVID-19 test kits that have been approved by the FDA are those being used at healthcare facilities and approved testing centers. To date, there is no home test kit for coronavirus and any vaccine for the virus is likely months away from being introduced. Nevertheless, the FDA has identified several fraudulent products being sold in the United States with misleading claims to cure, prevent, mitigate, diagnose or treat COVID-19.

FDA Issues Warning Letters to Manufacturers of Fraudulent COVID-19 Products

On March 24, the FDA issued a notice warning consumers about fraudulent coronavirus tests, vaccines and treatments. In the notice, the FDA indicates that while many Americans are practicing social distancing and self-isolating to help “flatten the curve” and slow or stop the spread of COVID-19, they may be tempted to buy or use “questionable products” that claim to treat, cure, diagnose or even prevent coronavirus. The agency warns consumers that these products have not been evaluated or approved by the FDA for safety and effectiveness and could pose a danger to users. Because COVID-19 has never been seen in humans before, there are currently no available vaccines to prevent or medications to treat the virus. According to the FDA, the agency is working with drug manufacturers to develop new vaccines for and find medications to treat coronavirus as quickly as possible. In the meantime, the FDA warns that “some people and companies are trying to profit from this pandemic by selling unproven and illegally marketed products that make false claims, such as being effective against the coronavirus.”

The firms marketing these fraudulent COVID-19 products are playing on consumers’ fears about the spread of the novel coronavirus, which has infected 772,025 people worldwide and resulted in 37,019 deaths. In the United States, 140,904 people have been infected by COVID-19 and 2,405 people have died as of March 30. These numbers are enough to make people worry about their own health and the health of their loved ones but buying and using unapproved and potentially dangerous products isn’t the way to go about protecting yourself from coronavirus. Beginning in early March, the FDA issued nine warning letters to firms suspected of selling or marketing products with fraudulent COVID-19 prevention and treatment claims. The firms accused of illegally selling products that claim to prevent, treat, diagnose or cure coronavirus include Corona-cure.com, Carahealth, Xephyr LLC dba N-ergetics, GuruNanda LLC, Quinessence Aromatherapy Ltd, Vivify Holistic Clinic, Colloidal Vitality LLC, The Jim Bakker Show and Herbal Amy Inc. The fraudulent coronavirus products these companies are selling include nasal sprays, herbal products, essential oil products, tinctures and other unapproved and potentially dangerous products.

Fraudulent Products Could Pose a Danger to Consumers

As the number of coronavirus cases in the U.S. continues to grow, fears about COVID-19 have reached a fever pitch. And as healthcare workers nationwide work to slow or stop the spread of COVID-19, federal regulators are concerned that these fraudulent products may prevent consumers from seeking appropriate medical treatment, which could have serious or possibly even life-threatening consequences. According to the FDA, these fraudulent coronavirus test kits and other products have not been medically proven to be capable of detecting or treating the virus and relying on them could delay the diagnosis of COVID-19 and the medical treatment required to save an infected individual’s life. Furthermore, the FDA warns that using fraudulent and unapproved COVID-19 test kits could lead to the more rapid spread of the disease.

Recommendations for Consumers with Symptoms of COVID-19

The FDA has announced that it is working with retailers to remove dozens of fraudulent and misleading coronavirus tests, vaccines and treatments from stores and online. Meanwhile, the agency is reportedly working with the CDC and drug manufacturers to make more COVID-19 diagnostic tests available, while maintaining adequate oversight in ensuring that the tests being deployed are accurate. During this public health crisis, consumers are being urged to remember that there is no “quick fix” for coronavirus and to remain suspicious of products that claim to treat, prevent or diagnose COVID-19. If you are experiencing symptoms of coronavirus, you are advised to follow the guidelines set forth by the CDC and contact your healthcare provider immediately for instructions on the appropriate method for seeking treatment.