The Food and Drug Administration (FDA) has issued a warning letter to Dr. Jason Korkus, DDS, and Sonrisa Family Dental, doing business as My COVID19 Club, of Chicago, Illinois, for marketing adulterated and misbranded COVID-19 antibody tests.
“Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” said Jeff Shuren, MD, JD, director of the 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,” said Shuren.
“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,” said Shuren.
According to the FDA, the practice’s website offered the Cellex Test Kit and Leccurate Test Kit for sale in the United States directly to consumers for at-home use even though these products don’t have marketing approval, clearance, or authorization from the FDA.
Also, the company’s website said that these products are “FDA approved,” using the FDA logo, the FDA said. Accordingly, the FDA said, these products are adulterated and misbranded, their marketing is misleading, and their interstate delivery is prohibited.
In the letter, the FDA asked the company to cease the sale of such unapproved, uncleared, and unauthorized products and correct the actions outlined in its letter. The FDA further noted that it has not yet approved, cleared, or authorized any COVID-19 serology test for at-home testing, as such practices in a home setting present potentially serious public health risks.
The company appears to have complied with the FDA’s request, and its website marketing the COVID-19 tests is no longer in operation.
“During the early days of COVID-19, as we fielded anxious questions from patients and others, we looked for ways to increase COVID-19 testing options. The testing product in question was originally on the FDA’s approved list or awaiting the emergency use authorization,” the company told CBS’s WBBM TV.
“However, we ultimately decided to remain focused on the mission of our practice and, therefore, not sell this product. No testing kits were ever procured or sold by Sonrisa Family Dental. And, we have complied with the FDA’s requested actions and apologize for any confusion we may have caused,” the company continued.
“Sonrisa Family Dental remains committed to the communities we serve and will continue to provide dental education, open access to clinics and outreach services,” it said.
The FDA reminds consumers to beware of websites and stores selling products, including test kits, that claim to prevent, mitigate, treat, diagnose, or cure COVID-19. Also, the FDA encourages healthcare professionals and consumers to report adverse events or quality problems experienced with the use of COVID-19 products to its MedWatch Adverse Event Reporting program.
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