FDA Coronavirus (COVID-19) Update: August 8th, 2020

Silver Spring, MD – The U.S. Food and Drug Administration has taken the following actions in its ongoing response effort to the COVID-19 Coronavirus pandemic:

On August 6th, the FDA revoked the emergency use authorization (EUA) for Autobio Diagnostics Co., Ltd.’s, Anti-SARS-CoV-2 Rapid Test, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test.

A COVID-19 Coronavirus antibody test, also known as a serology test, is a blood test that can detect if a person has antibodies to SARS-CoV-2, the virus that causes COVID-19 Coronavirus.

As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to one company for selling fraudulent COVID-19-related products. The company, Canadian Chaga, sells Chaga products, including “124 Chaga Capsules,” “Chaga Tea,” and “Canadian Chaga Tincture,” with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 Coronavirus in people.

There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus. FDA requested that Canadian Chaga immediately cease selling these unapproved and unauthorized products. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.

Today, FDA updated its Coronavirus Treatment Acceleration Program (CTAP) webpage with new metrics and FAQs. As of July 31st, 570+ drug development programs are in the planning stages and 270+ trials have been reviewed by FDA.

Testing updates:

To date, the FDA has currently authorized 207 tests under EUAs; these include 168 molecular tests, 37 antibody tests, and 2 antigen tests.

About the U.S. Food and Drug Administration

The U.S. Food and Drug Administration (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.