Agency cites 3 companies for selling unapproved direct-to-consumer tests

WASHINGTON — Three companies received warning letters from the FDA for marketing “adulterated or misbranded Covid-19 antibody tests.”

In a sharply worded statement, Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, said the FDA’s decision to provide regulatory flexibility in response to the Covid-19 public health emergency “never meant we would allow fraud.”

The companies in question are Medakit Ltd. of Sheung Wan, Hong Kong; and Yama Group; and Dr. Jason Korkus, DDS and Sonrisa Family Dental d/b/a My COVID19 Club of Chicago, Illinois, and the regulatory body said that the violations cited 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.”

At present, there are no antibody or diagnostic tests that are approved for exclusive at-home use, although the FDA noted that several diagnostic tests for Covid-19 are approved for “at-home collection of samples — such as from the nose or saliva — that can be sent to a lab for processing and test reporting.” There are no serology (antibody) tests for at-home collection, the FDA said.

“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,” Shuren added.

The companies need to take immediate action to correct the violations cited in the letters, “such as ceasing the sale of the products or preventing future sales.” If these steps are not taken, the FDA said next steps may include “legal action, including possible seizure and injunction.”

Candace Hoffmann, Managing Editor, BreakingMED™

Cat ID: 151

Topic ID: 88,151,254,930,570,730,933,190,926,192,927,151,725,928,925,934