Coronavirus (COVID-19) Update: Daily Roundup

SILVER SPRING, Md., April 28, 2020 /PRNewswire/ -- 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 FDA issued a new video resource explaining Emergency Use
        Authorizations (EUAs), one of several tools FDA uses to help make
        important medical products available quickly during public health
        emergencies like the COVID-19 pandemic. As the video explains, EUAs
        provide more timely access to drugs, diagnostic tests and/or other
        critical medical products that can help diagnose, treat and/or prevent
        COVID-19. When deciding whether to issue an EUA, the FDA evaluates the
        available scientific evidence very quickly and carefully balances any
        known and potential benefits and/or risks of these products to the
        public.
    --  The FDA and Federal Trade Commission (FTC) issued warning letters to two
        companies for selling fraudulent COVID-19 products, as part of the
        agency's effort to protect consumers. 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, Hopewell Essential Oils, offers essential
            oils and herbal products for sale in the U.S. with misleading claims
            that the products are safe and/or effective for the prevention and
            treatment of COVID-19.


        --  The second seller warned, Santiste Labs LLC, the "Defend(TM) Patch,"
            a transdermal patch containing a "composition of botanical oils,"
            for sale in the U.S. with misleading claims that the product is safe
            and/or effective for the prevention or treatment of COVID-19.


    --  As part of its work to help protect public health, FDA updated its FAQ
        page with information about smoking and COVID-19. Smoking cigarettes can
        leave smokers more vulnerable to respiratory illnesses such as COVID-19,
        which is why there's never been a better time to quit smoking. FDA's
        Every Try Counts campaign has supportive tips and tools to help smokers
        get closer to quitting for good.


    --  Today, the FDA posted information and resources to assist manufacturers
        submitting generic drug applications with bioequivalence studies that
        may be impacted during COVID-19.
    --  Diagnostics update to date:
        --  During the COVID-19 pandemic, the FDA has worked with more than 380
            test developers who have said they will be submitting emergency use
            authorizations (EUA) requests to FDA for tests that detect the
            virus.
        --  To date, the FDA has issued 50 individual emergency use
            authorizations for test kit manufacturers and laboratories. In
            addition, 22 authorized tests have been added to the EUA letter of
            authorization for high complexity molecular-based laboratory
            developed tests (LDTs).
        --  The FDA has been notified that more than 230 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.

Additional Resources:

    --  Coronavirus Disease 2019 (COVID-19)

Media Contact: Molly.Block@fda.hhs.gov, 240-701-7422
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