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Food and Drug Administration and Compliance Issues
Tuesday, May 5, 2020
Coronavirus (COVID-19) Update: Daily Roundup May 5, 2020
The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:
The FDA and Federal Trade Commission (FTC) issued warningletters 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, Honey Colony LLC, offers products including “Quicksilver Liposomal Vitamin C w/ Liposomal,” “Jigsaw Magnesium With SRT,” and products labeled to contain silver, including “Silver Excelsior Serum”, 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, Dr. Dhole’s Sushanti Homeopathy Clinic, offers products including “Homeopathic Genus Epidemicus” for sale in the U.S. with misleading claims that the product is safe and/or effective for the prevention of COVID-19.
Yesterday, FDA approved two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation: succinylcholine chloride injection USP 200 mg/10 mL and cisatracurium besylate injection USP 20 mg/10 mL. FDA recognizes the increased demand for certain products during the novel coronavirus pandemic and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
Diagnostics update to date:
During the COVID-19 pandemic, the FDA has worked with more than 385 test developers who have said they will be submitting EUA requests to the FDA for tests that detect the virus.
To date, the FDA has issued 59 individual EUAs for test kit manufacturers and laboratories. In addition, 25 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 240 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.