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FDA News Release

Coronavirus (COVID-19) Update: Daily Roundup September 30, 2020

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:

  • Today, the U.S. Food and Drug Administration (FDA) updated the SARS CoV-2 reference panel comparative data on FDA’s website to reflect the latest information. The FDA SARS-CoV-2 reference panel is a standardized performance validation step for authorized SARS-CoV-2 molecular diagnostic tests. The reference panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. The FDA intends to continue to update the tables on the website.
  • As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Tonic Therapeutic Herb Shop & Elixir Bar for selling unapproved products with fraudulent COVID-19 claims. The company sells various herbal products with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. FDA requested that Tonic Therapeutic Herb Shop & Elixir Bar, immediately stop selling these unapproved and unauthorized products. Consumers concerned about COVID-19 should consult with their health care provider.
  • In a new FDA Voices entitled, A Closer Look at the FDA’s Center for Devices and Radiological Health’s Unprecedented Efforts in the COVID-19 Response, FDA Commissioner Stephen M. Hahn, M.D. highlights how in just a few short months, the agency’s Center for Devices and Radiological Health’s response to the pandemic has been unprecedented in terms of volume, speed and agility – spanning multiple areas, including: regulatory flexibility, Emergency Use Authorizations (EUAs) for devices, shortage mitigation activities, Public Health Service Corps deployment and extensive engagement with stakeholders.

    The FDA also posted an infographic that provides a visualization of data associated with CDRH's response to the coronavirus (COVID-19) pandemic.
  • Testing updates:
    • As of today, 263 tests are authorized by FDA under EUAs; these include 208 molecular tests, 51 antibody tests, and 4 antigen tests.

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.

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