June 13, 2019
“As part of our continued efforts to communicate about risks that can arise when vitamin B7, or biotin, interferes with certain diagnostic tests, we’re issuing draft guidance to help assure the accuracy of select in vitro diagnostics when testing samples from individuals using biotin,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “In 2017, the FDA identified a significant safety issue with biotin interference with in vitro diagnostic tests and issued a safety communication containing recommendations to the public to help mitigate potential biotin interference. The draft guidance issued today builds upon our commitment to continue to monitor and address this ongoing issue, by providing proposed recommendations to manufacturers for designing studies to test for biotin interference and communicating those testing results with end-users, such as laboratory personnel. This draft guidance is an example of our work to help manufacturers design and develop safe and effective tests that benefit patients.”
Today, the U.S. Food and Drug Administration issued a draft guidance: Testing for Biotin Interference in In Vitro Diagnostic Devices. This draft guidance provides recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices.
Biotin, also known as vitamin B7, is a water-soluble vitamin often found in multi-vitamins, prenatal vitamins and dietary supplements marketed for hair, skin and nail growth. As the FDA reported in a safety communication in 2017, the agency is aware of people taking high levels of biotin that may cause interference with lab tests. Many diagnostic tests use biotin technology due to its ability to bind to specific proteins, which can be measured to detect certain health conditions. For example, biotin is used in hormone tests and tests for markers of cardiac health like troponin.
Many dietary supplements promoted for hair, skin, and nail benefits contain biotin levels up to 650 times the recommended daily intake of biotin. Physicians may also be recommending high levels of biotin for patients with certain conditions such as multiple sclerosis. Biotin in blood or other samples taken from patients who are ingesting high levels of biotin in dietary supplements can cause clinically significant incorrect lab test results such as falsely high or falsely low results, depending on the test.
While the 2017 safety communication provides recommendations for patients, health care professionals and laboratory personnel to mitigate potential biotin interference, today’s draft guidance provides additional recommendations to in vitro diagnostic device manufacturers for testing for biotin interference on in vitro diagnostic devices that use biotin technology and communicating the results of such testing to the end-users.
The FDA will continue its work with stakeholders to better understand biotin interference with laboratory tests, including working with manufacturers as they address this issue in designing and developing tests that use biotin technology. The FDA will continue to monitor adverse event reports and will update the public if significant new information becomes available.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.