Beware of Bogus COVID-19 Tests, Vaccines and Treatments

By Jane Farrell

While we remain vigilant to protect our families and communities from COVID-19, some people might be tempted to buy or use questionable products that claim to help diagnose, treat, cure, and even prevent coronavirus disease.

Vaccination is one of the best ways to protect everyone 12 and older from COVID-19. The U.S. Food and Drug Administration (FDA) has approved Comirnaty for the prevention of COVID-19 in people ages 16 and older. The vaccine has the same formulation as the Pfizer-BioNTech COVID-19 Vaccine that continues to be available under emergency use authorization (EUA), including for people ages 12 to 15. The FDA has also authorized other COVID-19 vaccines for emergency use in people 18 and older. For the latest information on vaccines, visit this FDA page.

The FDA continues to work with vaccine and drug manufacturers, developers, and researchers to help facilitate the development and availability of medical products – such as additional vaccines, antibodies, and medicines – to prevent or treat COVID-19.

Meanwhile, 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.

Unlike the products approved or authorized by the FDA, fraudulent products that claim to cure, treat, or prevent COVID-19 haven’t been evaluated by the agency for safety and effectiveness and might be dangerous to you and your family.

The FDA is particularly concerned that these deceptive and misleading products might cause people to delay or stop appropriate medical treatment for COVID-19, leading to serious and life-threatening harm. It’s likely that the products do not do what they claim, the FDA says in a Consumer Update news release, and the ingredients in them could cause adverse effects and could interact and potentially interfere with medications to treat many underlying medical conditions.

The FDA has also seen unauthorized fraudulent test kits for COVID-19 being sold online. You will risk unknowingly spreading COVID-19 or not getting treated appropriately if you use an unauthorized test.

The FDA is working with medical product developers to rapidly facilitate the development of vaccines and treatments for COVID-19 to help make them available. So far, the FDA has approved only one treatment for COVID-19 and has issued EUAs for others. For more information, click here.  

Fraudulent COVID-19 products can come in many varieties, including dietary supplements and other foods, as well as products claiming to be tests, drugs, medical devices, or vaccines. The FDA has been working with retailers to remove dozens of misleading products from store shelves and online. The agency will continue to monitor social media and online marketplaces promoting and selling fraudulent COVID-19 products.

For example, the FDA and the Federal Trade Commission issued warning letters to companies for selling fraudulent COVID-19 products. The products cited include teas, essential oils, tinctures, and colloidal silver.

The FDA is actively monitoring for any firms marketing products with fraudulent COVID-19 diagnostic, prevention, and treatment claims. The FDA is exercising its authority to protect consumers from firms selling unauthorized products with false or misleading claims. The FDA may send warning letters, or pursue seizures or injunctions against people, products, or companies that violate the law. We are also increasing our enforcement at ports of entry to ensure that fraudulent products do not enter the country through our borders.

In addition, the FDA is monitoring complaints of fake coronavirus treatments, vaccines, and tests. Consumers and health care professionals can help by reporting suspected fraud to the FDA’s Health Fraud Program or the Office of Criminal Investigations.

Products marketed for veterinary use, or “for research use only,” or otherwise not for human consumption, have not been evaluated for safety and should never be used by humans. They may have adverse effects, including serious illness and death, when taken by people.

The FDA has received multiple reports of people who have needed medical attention, including hospitalization, after self-medicating with ivermectin intended for livestock. The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. The FDA is also aware of people trying to prevent COVID-19 by taking chloroquine phosphate, which is sold to treat parasites in aquarium fish.

The FDA advises consumers to be cautious of websites and stores selling products that claim to prevent, treat, or cure COVID-19.

Here are some tips to identify false or misleading claims.

Be suspicious of products that claim to treat a wide range of diseases.

Personal testimonials are no substitute for scientific evidence.

Few diseases or conditions can be treated quickly, so be suspicious of any therapy claimed as a “quick fix.”

If it seems too good to be true, it probably is.

“Miracle cures,” which claim scientific breakthroughs or contain secret ingredients, are likely a hoax.

If you have symptoms of COVID-19, speak to your medical provider. Your health care provider will advise you about whether you should get tested and the process for being tested in your area.

If you have a question about a treatment or test found online, talk to your health care provider or doctor. If you have a question about a medication, call your pharmacist or the FDA. The FDA’s Division of Drug Information (DDI) will answer almost any drug question. DDI pharmacists are available by email, druginfo@fda.hhs.gov, and by phone, 1-855-543-DRUG (3784) and 301-796-3400.