FDA News Release
FDA Roundup: March 25, 2022
- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA is issuing a 30-day procedural notice on the preliminary quantitative consumer research it plans to conduct on voluntary symbols that could be used in the future to convey the nutrient content claim “healthy.” This notice summarizes and responds to comments the FDA received on a 60-day procedural notice issued in May 2021.
- Today, the FDA announced the COVID-19 treatment sotrovimab is no longer authorized for use at this time in the U.S. Health and Human Services (HHS) regions 1 and 2 due to the high frequency of the Omicron BA.2 sub-variant and data showing that the authorized dose of sotrovimab is unlikely to be effective against that sub-variant. Therefore, sotrovimab may not be administered for treatment of COVID-19 in these regions under the emergency use authorization until further notice by the agency:
- Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont (HHS Region 1)
- New Jersey, New York, Puerto Rico, and the Virgin Islands (HHS Region 2)
- On March 24, the FDA published the FDA Voices: “Improving Nutrition to Turn the Tide on Diet-Related Chronic Disease,” by Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition. March is National Nutrition Month, and the FDA is shining a spotlight on the importance of good nutrition and the big impact it has on improving people’s lives and lowering the enormous costs of diet-related chronic diseases. The FDA continues to work with our federal partners to create a healthier food supply, empower consumers with information to choose healthier diets and establish healthy eating habits early.
- COVID-19 testing updates:
- As of today, 425 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 293 molecular tests and sample collection devices, 84 antibody and other immune response tests and 48 antigen tests. There are 74 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 15 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 28 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 897 revisions to EUA authorizations.
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.
- FDA Office of Media Affairs