COVID-19 – FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk

This information is not surprising. During the times of consumer and govt panic, there will always be companies trying to take advantage of situation. The FDA tries their best to keep on top of the situation to weed out misbranded and adulterated products. WE can tell you that you can expect to see a lot more of these types of warning letters coming in the next few weeks and months.

Three companies were issued warning letters from the FDA for marketing adulterated and misbranded COVID-19 antibody tests. These tests may be important in fighting this pandemic, as they may provide information on disease prevalence and the frequency of asymptomatic infection.

Warning letters were issued to: Medakit Ltd. 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.

The FDA makes note that there are presently no diagnostic or antibody COVID-19 test kits that are authorized, cleared or approved to be used completely at home. Test kits used in the home can bring forward unique and potentially serious public health risks, including whether a lay user has the ability to collect their specimen, run the test, and interpret their results accurately. The FDA however has authorized several diagnostic COVID-19 tests for use with at-home collection of samples through the nose or saliva, that can then be sent to a lab for processing and test reporting. There are currently no serology tests that are authorized for use with at-home collection of samples.

The FDA requested that these companies take the immediate steps to correct their violations, which include ceasing the sale of the products or preventing future sales. Failure to immediately correct the violations cited in the warning letters may result in legal action, including possible seizure and injunction.

The FDA reminds the public to be cautious of websites and stores selling products, including test kits, that claim to prevent, mitigate, treat, diagnose, or cure COVID-19. Fraudulent products defraud the public of money and can be placed at risk for serious harm. The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of COVID-19 products to the FDA’s MedWatch Adverse Event Reporting program.

To read the full press release from the FDA, please visit their website.

For any further questions on serology tests and FDA regulation and compliance, please email mdi Consultants at [email protected] RE: COVID19.