- 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:
- As part of FDA’s effort to protect consumers, the agency issued a warning letter to one company for selling fraudulent COVID-19 products. The company, Curativa Bay Corporation, offers Hypochlorous Skin Spray, a topical hypochlorous acid-containing product for sale in the United States with misleading claims that the product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. 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.
- FDA updated the templates for laboratories and commercial manufacturers to help facilitate submission of Emergency Use Authorization (EUA) requests for serology tests. The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data; the updates also provide new recommendations for validation of point-of-care tests.
- Testing updates:
- To date, there are 153 currently authorized tests under EUAs; these include 129 molecular tests, 23 antibody tests, and 1 antigen test.
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.
- Lee Herring