- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- On May 26, the FDA posted warning letters to multiple companies illegally selling CBD products intended for use in food-producing animals. Although the FDA does not know the current extent of CBD use in food-producing animals, the agency is taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply. The companies also sell CBD-containing unapproved new drugs for humans and adulterated human foods. Some of the products were marketed as dietary supplements even though CBD-containing products do not meet the definition of a dietary supplement.
- On May 20, the FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. FDA granted this extension following a thorough review of data submitted by Eli Lilly. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 here). This extension applies to all unopened vials of bebtelovimab that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 433 KB) and the EUA Letter of Authorization (PDF, 111 KB) for bebtelovimab. As required by the EUA, unopened vials of bebtelovimab injection, 175 mg/2 mL, must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
- On May 19, the FDA issued a warning letter to Santhigram Kerala Ayurvedic Co. of U.S., Inc. for selling unapproved products with fraudulent claims to treat multiple diseases, including COVID-19. The FDA also issued a warning letter to Ayuryoga, Inc. for selling unapproved products with fraudulent claims to treat multiple diseases. Consumers concerned about COVID-19 should consult with their health care provider.
- On May 17, the FDA revised the scope of authorization for Evusheld’s EUA to include new information on hypersensitivity reactions and the risk of cross-hypersensitivity with COVID-19 vaccines and related clinical recommendations. Clinicians should consider consulting an allergist-immunologist prior to administering Evusheld to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to a COVID-19 vaccine. For all individuals, Evusheld should be administered under the supervision of a health care provider with appropriate medical support to manage severe allergic reactions. In addition, everyone who receives Evusheld should be observed after injection for at least one hour to monitor for hypersensitivity reactions.
- COVID-19 testing updates:
- As of today, 436 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 84 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 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, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 27 antigen tests and 7 molecular tests for serial screening programs. The FDA has also authorized 987 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.