Coronavirus (COVID-19) Update: February 16, 2021

FDA News Release

• For Immediate Release: February 16, 2021

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 the FDA’s effort to protect consumers, the agency issued a warning letter to Evolved Ayurvedic Discoveries, Inc./BioCBDPlus for selling unapproved products, including unapproved products with fraudulent COVID-19 claims. The company sells cannabidiol (CBD) products, including “BioCBD+ Total Body Care,” “BioCBD+ Topical Oil Muscle & Joint Support,” and “BioCBD+ Peace Vape,” and misleadingly represents the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. Consumers concerned about COVID-19 should consult with their health care provider.
• Testing updates:
  • As of today, 331 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 247 molecular tests and sample collection devices, 70 antibody tests and 14 antigen tests. There are 37 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test and one over-the-counter (OTC) at-home 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.