FDA has issued warning letters to companies for marketing adulterated and misbranded covid-19 antibody tests. Generally, antibody tests, also called serological tests, detect antibodies to SARS-CoV-2, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection. These tests may be important in the fight against this pandemic, as they may provide information on disease prevalence and the frequency of asymptomatic infection. The warning letters issued on June 17, 2020, are the first set of letters the agency has issued for marketing adulterated or misbranded covid-19 test kits.
“Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” says Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health. “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 United States, taking appropriate action as warranted.”
Warning letters were issued to: Medakit of Sheung Wan, Hong Kong; Antibodiescheck.com and Yama Group; and Dr. Jason Korkus, DDS and Sonrisa Family Dental d/b/a My COVID19 Club of Chicago, Illinois. Violations outlined in the warning letters include: offering test kits for sale in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from the FDA; misbranding products with labeling that falsely claims products are “FDA approved”; and labeling that bears the FDA logo, which is only for the official use by the FDA and not for use on private sector materials.
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