FDA News Release
Coronavirus (COVID-19) Update: March 12, 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:
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter to Cannafyl for selling unapproved products with fraudulent COVID-19 claims. The company sells CBD-containing products, including “Balance CBD Drops,” “Relief CBD Drops,” “Relax CBD Drops” and “Relief CBD Salve,” and misleadingly represents the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. The FDA requested that Cannafyl 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.
- Today, the FDA issued a Letter to Clinical Laboratory Staff, Point-of-Care Facility Staff and Health Care Providers to alert them that false positive results can occur with the Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System.
- Today, the FDA issued an Emergency Use Authorization (EUA) for Propofol-Lipuro 1% injectable emulsion for infusion to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit setting during the COVID-19 public health emergency. Propofol-Lipuro 1% injectable emulsion for infusion is not FDA-approved and has important differences in its formulation compared to FDA-approved propofol drugs; providers should consult the Health Care Provider Fact Sheet for more information before administering it.
- Testing updates:
- As of today, 341 tests and sample collection devices are authorized by the FDA under 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 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.
- Audra Harrison