Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., Aug. 10, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

    --  As part of the FDA's effort to protect consumers, the agency issued a
        warning letter to one firm for selling unapproved products with
        fraudulent COVID-19 claims. The company, H-Lab Life, sells "Multi-Use
        Spray" 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 H-Lab Life immediately cease selling these unapproved
        products. Consumers concerned about COVID-19 should consult with their
        health care provider.

    --  FDA has taken additional action to help ensure that hand sanitizers
        produced under the agency's temporary guidances do not contain unsafe
        levels of methanol. FDA has updated its guidances to provide
        clarification that companies test each lot of the active ingredient
        (ethanol or isopropyl alcohol (IPA)) for methanol, if the ethanol or IPA
        is obtained from another source. FDA has also included an additional
        denaturant formula in the temporary guidances. Denaturing alcohol in
        hand sanitizers is critical to deter children from unintentional
        ingestion. Consumer and health care personnel safety is a top priority
        for FDA, and an important part of FDA's mission is to protect the public
        from harm, especially as we seek to facilitate an increase in the supply
        of hand sanitizer.

    --  FDA issued an Emergency Use Authorization to George Washington
        University Public Health Laboratory for its GWU SARS-CoV-2 RT-PCR Test.
        This molecular test is for use by health care providers for the
        qualitative detection of nucleic acid from SARS-CoV-2 in upper
        respiratory specimens (e.g., nasal, mid-turbinate, nasopharyngeal and
        oropharyngeal swabs) from individuals suspected of having contracted
        COVID-19. Administration of this test is limited to the George
        Washington University Public Health Laboratory.

    --  Testing updates:
        --  To date, the FDA has currently authorized 208 tests under EUAs;
            these include 169 molecular tests, 37 antibody tests, and 2 antigen
            tests.

Additional Resources:

    --  FAQs on Testing for SARS-CoV-2
    --  Policy for Coronavirus Disease-2019 Tests During the Public Health
        Emergency (Revised)
    --  Coronavirus Disease 2019 (COVID-19)

Media Contact: Lee.Herring@fda.hhs.gov
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.

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SOURCE U.S. Food and Drug Administration