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Food and Drug Administration and Compliance Issues
The U.S. Food and Drug Administration today continued to take action in the ongoing response effort to the COVID-19 pandemic:
Today, FDA and the U.S. Department of Agriculture released recommendations to help address shortages of personal protective equipment (PPE), cloth face coverings, disinfectants, and sanitation supplies in the food and agriculture industry during the COVID-19 pandemic.
The FDA issued a guidance document to provide additional temporary flexibility in food labeling requirements to manufacturers and vending machine operators. The agency is providing flexibility for manufacturers to make minor formulation changes in certain circumstances without making conforming label changes. Also, the FDA is providing temporary flexibility to the vending machine industry and will not object if covered operators do not meet vending machine labeling requirements to provide calorie information for foods sold in the vending machines at this time.
The FDA and the Federal Trade Commission issued a warningletter 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, Apollo Holding LLC, offers “NoronaPak” products, including cannabidiol (CBD) and other supplement products for sale in the U.S. with claims that misleadingly represent the products as safe and/or effective for the prevention and treatment of COVID-19.
The second seller warned, North Coast Biologics LLC, has offered the unapproved “nCoV19 spike protein vaccine” for sale in the U.S. with misleading claims that the product is safe and/or effective for the prevention of COVID-19.
The FDA updated the FAQs on Testing for SARS-CoV-2 to clarify information about at-home self-collection and what tests should no longer be distributed for COVID-19.
Test developers can offer their COVID-19 tests for at-home self-collection of a specimen if at-home self-collection of a specimen is specifically authorized under the Emergency Use Authorization (EUA) for the test. In addition, COVID-19 tests for at-home self-collection may be used as part of an Institutional Review Board-approved study. The FDA is supportive of at-home self-collection and has authorized several COVID-19 tests for home collection of specimens to be sent to a laboratory for processing and test reporting.
The FDA added a new section to the FAQs to clarify what tests should no longer be distributed for COVID-19. Yesterday, the FDA posted a list of commercial manufacturers’ antibody tests that have been removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending EUA request or issued EUA. FDA expects that the tests on the removal list will not be distributed.
During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
To date, the FDA has authorized 109 tests under EUAs, which include 96 molecular tests, 12 antibody tests, and 1 antigen test.