- 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:
- The FDA and the Federal Trade Commission (FTC) jointly issued a warning letter to Hong Kong-based SuperHealthGuard and Loyal Great International, Ltd., advising these companies to cease selling unapproved products online to customers in the United States with misleading claims that such products mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The FDA’s action is in support of its efforts to protect the public health. FTC’s action enforces provisions of the FTC Act, 15 U.S.C. 41, prohibiting unsupported drug advertising claims. There are no drugs approved by the FDA to prevent or cure COVID-19 in people. FDA advised the companies to review their respective websites to ensure that they are not misleadingly representing unproven products as safe and effective for a COVID-19-related use. Failure to immediately correct the unapproved new drug and misbranding violations could result in legal action, including, without limitation, seizure and injunction. FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Misbranded or unapproved new drugs are subject to detention and refusal of admission, if they are offered for importation into the United States. The list of firms that have received warning letters is located here.
- FDA issued Emergency Use Authorizations (EUAs) for the following SARS-CoV-2 molecular diagnostic tests:
- FDA added the following products to the list of authorized ventilators, ventilator tubing connectors, and ventilator accessories under the ventilator Emergency Use Authorization (EUA)
- Stewart & Stevenson Healthcare Technologies, LLC: Apollo ABVM emergency resuscitator
- SAGICO USA, LLC: V2O SAGICO SYSTEM Ventilator
- Testing updates:
- To date, the FDA has authorized 155 tests under EUAs; these include 130 molecular tests, 24 antibody tests, and 1 antigen test.
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.
- Lee Herring