FDA issues warning letters to companies marketing COVID-19 antibody tests for at-home use

June 19, 2020

The U.S. Food and Drug Administration (FDA) has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests, according to a press release from the agency.

The FDA said the companies were marketing the test kits directly to consumers for at-home use without FDA authorization, even though the agency has not approved any diagnostic or antibody COVID-19 tests to be used completely at home. However, FDA has granted emergency use authorization (EUA) to multiple organizations for the at-home collection of nasal and saliva samples, which consumers then ship to labs for testing.

Other violations included using labels to claim that the products were FDA approved, as well as using the official FDA logo.

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