Coronavirus (COVID-19) Update: Daily Roundup September 10, 2020

FDA News Release

• For Immediate Release: September 10, 2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

• As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Pharmacy Plus, Inc. dba Vital Care Compounder for selling unapproved products with fraudulent COVID-19 claims. The company sells “COVID PACK” and “COVID ‘POSITIVE’ PACK” products with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. FDA requested that Pharmacy Plus, Inc. dba Vital Care Compounder immediately stop selling these unapproved and unauthorized products. Consumers concerned about COVID-19 should consult with their health care provider.
• Testing updates:
  • As of today, 247 tests are authorized by FDA under EUAs; these include 197 molecular tests, 46 antibody tests, and 4 antigen tests.

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.