FDA Coronavirus (COVID-19) Update: August 6th, 2020

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

The FDA issued its first warning letter to New Life International and its second warning letter to Fishman Chemical of North Carolina, LLC, both of which distribute chloroquine phosphate products intended to treat disease in aquarium fish.

Chloroquine phosphate intended to treat disease in aquarium fish has not been approved, conditionally approved, or indexed.

Although neither company identified in today’s warning letters made claims about these products’ use by people, the agency is concerned that consumers may mistake, and have mistaken, unapproved chloroquine phosphate animal drugs for the human drug chloroquine phosphate.

People should not take any form of chloroquine unless it has been prescribed by a licensed health care provider.

Testing updates:

To date, the FDA has currently authorized 203 tests under EUAs; these include 166 molecular tests, 35 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.