White Oak, MD…The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• The FDA and Federal Trade Commission (FTC) issued warning letters to three sellers of fraudulent COVID-19 products, as part of the agency’s effort to protect both people and pets. With these warning letters, the FDA is exercising its authority to protect consumers from companies selling unapproved products with false or misleading claims during the COVID-19 pandemic. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider:
  • The first seller warned, Herbs of Kedem, sells unapproved and misbranded herbal products for the prevention and treatment of COVID-19.
  • The second seller warned, the GBS dba Alpha Arogya India Pvt Ltd, offers unapproved and misbranded ayurvedic products including “Alpha 11” and “Alpha 21” for sale in the U.S. with misleading claims about the prevention or treatment of COVID-19.
  • The third seller warned, Gaia Arise Farms Apothecary, offers unapproved and misbranded products including “True Viral Defense” also referred to as “Viral Defense Tincture.” The company makes misleading claims the products are safe and/or effective for the treatment or prevention of COVID-19 in people.
• Diagnostics update to date:
  • During the COVID-19 pandemic, the FDA has worked with more than 300 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
  • To date, 34 emergency use authorizations have been issued for diagnostic tests.
  • The FDA has been notified that more than 180 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 up to date, including updated FAQs regarding at-home testing:
    • At this time, the FDA has not authorized any COVID-19 test for at-home testing, including self-collection of a specimen with or without the use of telemedicine.
    • The FDA is supportive of at-home testing for COVID-19, provided there is data and science to support consumer safety and test accuracy. We are actively working with developers toward the goal of authorizing EUAs for home use tests once appropriate validation has been completed. Home collection raises several issues of importance, including whether the lay user can safely and properly collect the specimen, whether the components of the specimen transport media are safe for use in the home environment (since some may be toxic), proper shipment, and adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions (such as, if the specimen sits in a hot truck). A physician watching the collection by way of telemedicine may address the issue of proper specimen collection (if the self-collection method does not raise safety concerns) but it does not address the other issues, and specimen stability and shipping conditions are still of concern.

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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