SILVER SPRING, Md., June 29, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

The FDA and the Federal Trade Commission (FTC) jointly issued a

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

.FDA issued Emergency Use Authorizations (EUAs) for the following SARS-CoV-2 molecular diagnostic tests: Inform Diagnostics, Inc.:

Diagnostic Solutions Laboratory, LLC:

FDA added the following products to the list of

under the

Stewart & Stevenson Healthcare Technologies, LLC: Apollo ABVM emergency resuscitatorSAGICO USA, LLC: V2O SAGICO SYSTEM VentilatorTesting updates:To date, the FDA has authorized 155 tests under EUAs; these include 130 molecular tests, 24 antibody tests, and 1 antigen test.

Additional Resources:

Media Contact:, 240-402-6386 Consumer Inquiries: 888-INFO-FDA

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.

SOURCE U.S. Food and Drug Administration

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