- 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 cautioned pet owners not to feed their pets certain lots of Darwin’s Natural Pet Products raw cat food after samples from these lots tested positive for Salmonella. These foods have been associated with cases of illness in three kittens in a single household. Whole genome sequencing of the Salmonella in the two products revealed that the turkey product contained Salmonella Typhimurium, while the chicken product contained Salmonella Typhimurium and Kentucky.
- On Thursday, the FDA released new “Feed your Mind” educational materials to provide science-based information on genetically modified organisms (GMOs) to consumers, health educators, dietitians, and other health care professionals. “Feed Your Mind” is an education initiative launched in 2020 to help increase consumer understanding of GMOs and was developed in partnership with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency.
- On Wednesday, the FDA published the FDA Voices: “FDA Recognizes National Immunization Awareness Month,” by Robert M. Califf, M.D., FDA Commissioner. The FDA plays a key role in immunization by evaluating vaccines for safety and effectiveness before they are made available to the public. National Immunization Awareness Month provides us an opportunity to think about how far the development and advancement of immunization science has come, and its impact on public health.
- On Wednesday, the FDA updated the list of Breakthrough Devices that have been authorized for marketing. The list now includes more than 50 Breakthrough Devices that the FDA has authorized for marketing. Online metrics show the number of granted Breakthrough Device designations by fiscal year and by clinical panel. The Breakthrough Devices Program provides patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving the statutory standards consistent with the FDA’s mission to protect and promote public health.
- On Wednesday, Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products, shared an update on the agency’s review and enforcement of non-tobacco nicotine products. Dr. King’s update, among other things, includes information on acceptance review of applications and new warning letters to manufacturers and retailers of non-tobacco nicotine products.
- COVID-19 testing updates:
- As of today, 439 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 78 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1070 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.