FDA sends first warning letters for fraudulent marketing of antibody tests

Regulatory NewsRegulatory News | 19 June 2020 |  By 

The US Food and Drug Administration this week issued its first set of warning letters for marketing adulterated or misbranded COVID-19 antibody tests.
The letters, sent to Medakit Ltd. of Hong Kong, Antibodiescheck.com of United Arab Emirates, and Sonrisa Family Dental dba www.mycovidtest19.com of Chicago, cited a range of violations. These included offering test kits for sale in the US directly to consumers for at-home use without marketing approval, clearance, or authorization from the FDA; misbranding products with labeling that falsely claims the products were approved by the agency; and using the FDA logo on the labeling.
The agency requested immediate correction of the violations and noted that failure to do so might result in legal action that could extend to seizure and injunction.
“Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” said Jeff Shuren, MD, director of the agency’s Center for Devices and Radiological Health. “When tests are marketed inappropriately, with inaccurate or misleading claims … 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 US, taking appropriate action as warranted.”
FDA has authorized some diagnostic COVID-19 tests for use with at-home collection of samples, such as nasal secretions or saliva, that can be sent to a laboratory for processing and interpretation.
However, the agency reiterated that currently, no diagnostic or antibody COVID-19 test kits have been authorized solely for home use. No serology home-test kits have been authorized for use with at-home sample collection. FDA stressed that home testing comes with serious possible public health risks, including whether the user has the ability to conduct the test and accurately interpret the results, and warned consumers to be cautious of websites or stores claiming their products could prevent, diagnose or treat COVID-19.
Antibody, or serologic, tests detect antibodies to coronavirus and help identify individuals who have developed an adaptive immune response to the virus, because they are either actively infected or have been infected. The test results may collectively provide information on disease prevalence and asymptomatic infection.


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