The FDA announced that it issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests.
Medakit, Antibodiescheck.com and Yama Group and Dr. Jason Korkus, DDS & Sonrisa Family Dental d/b/a My COVID19 Club all received warnings.
In the warnings, the agency outlined violations including offering test kits for sale in the U.S. directly to consumers for at-home use without marketing approval, clearance or authorization from the FDA. The letters also noted misbranding by claiming that products are “FDA-approved” and labeling that bears the FDA logo, which is not meant for use on private sector materials.
The FDA said in a news release that there are no diagnostic or antibody COVID-19 test kits that are authorized to be used completely at home, but there are tests for use with at-home sample collection followed by processing and reporting at a laboratory.
Violators are urged to take immediate steps to correct the transgressions, including ceasing the sale of the products or preventing future sales. Failure to immediately correct the cited violations may result in legal action, including possible seizure and injunction.
“Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” FDA Center for Devices & Radiological Health director Dr. Jeff Shuren said in the news release. “When tests are marketed inappropriately, with inaccurate or misleading claims – such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not – they put the health of Americans at risk. Such conduct will not be tolerated by the FDA, and we will continue to monitor tests marketed in the U.S., taking appropriate action as warranted.”