Silver Spring, MD – The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
Wednesday, the FDA issued a Consumer Update, Tips on Good Nutrition and Using the Updated Nutrition Facts Label During the Coronavirus Pandemic [1].
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The update provides helpful tips on how to use the Nutrition Facts label to learn more about the foods you have on hand or are purchasing online or in stores, especially if you are purchasing different foods because of temporary disruptions in the food supply chain [3] or are buying more canned or packaged foods instead of fresh.
With support from the FDA’s Office of Criminal Investigations and Office of the Chief Counsel, the U.S. Department of Justice announced [4] today that a federal court in Utah has entered an injunction halting the sale of various silver products, promoted as treatments for COVID-19 Coronavirus.
“The FDA will continue to help ensure those who place profits above the public health during the COVID-19 Coronavirus pandemic are stopped,” said Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs. “We are fully committed to working with the Department of Justice to take appropriate action against those jeopardizing the health of Americans by offering and distributing products with unproven claims to prevent or treat COVID-19 Coronavirus.”
The FDA granted accelerated approval [5] to a new dosing regimen for a cancer therapy, to allow patients with certain cancers to continue treatment with fewer in-person visits. Specifically, the new dosing regimen allows patients to visit cancer centers less often while getting the treatment they need. This application was approved more than five months prior to the FDA goal date.
Tuesday, the FDA issued an Emergency Use Authorization (EUA) for SARS-CoV-2 Antibody Tests [6] that have been evaluated in an independent validation study performed at the National Institutes of Health’s (NIH) National Cancer Institute (NCI), or by another government agency designated by FDA, and are confirmed by FDA to meet the criteria set forth in the Scope of Authorization. Under this serology “umbrella” EUA, authorized devices are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, by detecting antibodies (IgG, or IgG and IgM, or total), as specified in each authorized device’s instructions for use, to SARS-CoV-2 in human plasma and/or serum. Emergency use of the authorized devices is limited to the authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 to perform moderate or high complexity tests. Authorized devices will be added to Appendix A and will be posted on the FDA’s website.
The FDA recently posted FAQs on Ventilators [7], including questions and answers related to the Enforcement Policy on Ventilators and Ventilators added to the “Umbrella” EUA, which added to the existing FAQs on Public Availability (Open Sourcing) of Ventilator Software and Design.
The FDA also recently posted FAQs on EUAs for Medical Devices During the COVID-19 Pandemic [8], including how to submit a request for a new EUA and what happens to authorized devices after the public health emergency is over.
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Diagnostics update to date:
- During the COVID-19 Coronavirus pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
- To date, the FDA has issued 50 individual emergency use authorizations [9] for test kit manufacturers and laboratories. In addition, 23 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
- The FDA has been notified that more than 235 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
- The FDA also continues to keep its COVID-19 Diagnostics FAQ [10] up to date.
Additional Resources:
Consumer Inquiries: 888.INFO.FDA
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.