FDA News Release
Coronavirus (COVID-19) Update: March 16, 2021
- 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:
- On March 15, 2021, the FDA launched the COVID-19 EUA FDA Adverse Events Reporting System (FAERS) Public Dashboard providing weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under an EUA during the COVID-19 public health emergency.
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Ravenscroft Apothecary, Inc. DBA Ravenscroft Escentials for selling unapproved products with fraudulent COVID-19 claims. The company sells products, including “AIR PURIFY AROMAMIST,” “HEALER’s CHAI AROMATEA & BREATH DROPS,” “ELEVATION OF MIND AROMAMIST” and “ROSE FREQUENCY TONGUE TINCTURE,” and misleadingly represents the products as safe and/or effective to mitigate, prevent, treat, diagnose or cure COVID-19 in people. The FDA requested that Ravenscroft Apothecary, Inc. take immediate action to cease the sale of any unapproved and unauthorized products for the treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
- The FDA has posted translations of the Janssen COVID-19 Vaccine fact sheet for recipients and caregivers in languages including: Burmese, Chinese, French, Hindi and Russian. We will post additional language translations of the fact sheet for recipients and caregivers to this page as they become available.
- Testing updates:
- As of today, 341 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 254 molecular tests and sample collection devices, 72 antibody and other immune response tests and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test, one over-the-counter (OTC) at-home antigen test and one OTC molecular 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.
- Shirley Simson