- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA issued a new video resource explaining Emergency Use Authorizations (EUAs), one of several tools FDA uses to help make important medical products available quickly during public health emergencies like the COVID-19 pandemic. As the video explains, EUAs provide more timely access to drugs, diagnostic tests and/or other critical medical products that can help diagnose, treat and/or prevent COVID-19. When deciding whether to issue an EUA, the FDA evaluates the available scientific evidence very quickly and carefully balances any known and potential benefits and/or risks of these products to the public.
- The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
- The first seller warned, Hopewell Essential Oils, offers essential oils and herbal products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
- The second seller warned, Santiste Labs LLC, the “DefendTM Patch,” a transdermal patch containing a “composition of botanical oils,” for sale in the U.S. with misleading claims that the product is safe and/or effective for the prevention or treatment of COVID-19.
- As part of its work to help protect public health, FDA updated its FAQ page with information about smoking and COVID-19. Smoking cigarettes can leave smokers more vulnerable to respiratory illnesses such as COVID-19, which is why there’s never been a better time to quit smoking. FDA’s Every Try Counts campaign has supportive tips and tools to help smokers get closer to quitting for good.
- Today, the FDA posted information and resources to assist manufacturers submitting generic drug applications with bioequivalence studies that may be impacted during COVID-19.
- Diagnostics update to date:
- During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
- To date, the FDA has issued 50 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 22 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
- The FDA has been notified that more than 230 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
- The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Molly Block