Violations include offering test kits for sale in the U.S. directly to consumers for at-home use without first receiving the necessary marketing approval, clearance, or authorization.
The U.S. Food and Drug Administration (FDA) issued advisory letters to three companies that have allegedly been promoting faux antibody tests for the treatment of COVID-19. The products and related marketing content reviewed by the FDA, and were singled out for marketing directly to customers at home, without the involvement of a health care professional, and evaluated as adulterated and misbranded.
“Providing regulatory flexibility during this public health emergency never meant we would allow fraud,” said Jeff Shuren, M.D., J.D., 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 — the (violators) put the health of Americans at risks.”
The FDA issued warning letters to Medakit Ltd. of Sheung Wan, Hong Kong; Antibodiescheck.com and Yama Group; and Dr. Jason Korkus, DDS and Sonrisa Family Dental (My COVID19 Club) of Chicago, Illinois. Violations include offering test kits for sale in the U.S. directly to consumers for at-home use without first receiving the necessary marketing approval, clearance, or authorization from the FDA.
The FDA maintains an ongoing effort of vigilance to prevent companies from operating outside set policy guidelines. The letters, to the three companies, were announced on June 17th. The first of their kind to be sent out, the warning letters are an initial step in preventing the sale or marketing of these products. If there is no measurable response or action taken from the companies named, the FDA has the option to pursue additional steps, including taking legal action and seizure of the products that are violating the FDA policies.
Antibody tests (also known as serological tests) detect antibodies to SARS-CoV-2, which can help identify people who might have developed an adaptive immune response to the virus. The immune response can be part of either an active infection or a prior one. These tests may be necessary in the fight against this pandemic. They could potentially provide updated information on potential disease prevalence and help assess the current level of asymptomatic infection.
According to the Mayo Clinic, antibody tests are essential in determining who has the virus and to assess how it might be spreading. A medical professional uses finger prick or by drawing blood from a vein in the arm. The sample is tested to ascertain whether you have developed antibodies against the virus. The immune system produces these antibodies — proteins that are potentially critical for fighting and clearing out the infection.
The FDA also advised medical professionals and health care providers, that it regularly posts updates (at https://www.fda.gov/) about products, medical information, and corrective actions it takes during the COVID-19 public health emergency. Similarly, the FDA requests that healthcare professionals report questionable products or medically risky situations to the Agency. Reports can be submitted online at MedWatch located here. Medical professionals can also register for FDA information updates at the link.