“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,” the agency said in its alert, posted Tuesday this week.
In one extreme example, the FDA cited the death of one patient who took high levels of biotin, caused by a falsely low troponin test result which was administered using a test known to have biotin interference. Troponin is an important biomarker to aid in the diagnosis of heart attacks.
How can manufacturers pitch in?
While the FDA offered recommendations for healthcare practitioners, lab technicians, and consumers, is there any way that manufacturers of finished products containing biotin can also play a role?
“Manufacturers have a role to help educate consumers and healthcare providers about the impact of biotin on lab tests," MacKay told NutraIngredients-USA.
"Adding a specific statement on biotin products is one option, but also products can be labeled with a statement that reminds consumers to talk to their doctor about the products that they take. It is incredibly important to talk to your doctor about all the various health-related products (drugs and supplements) because there are a variety of products beyond dietary supplements that might interfere with a lab test. Remember that forgetting to fast before blood work skews results.”
Biotin, also known as vitamin B7, appears in products from multivitamins to prenatal, but features prominently in supplements marketed for hair, skin, and nail benefits—the so-called ‘Beauty-from-Within’ supplements. The US has the seventh largest beauty supplement market in the world, valued at $76 million in 2015, according to data from market research firm Euromonitor.
These supplements, according to the FDA, contain levels up to 650 times the recommended daily intake of biotin. Another source of exceedingly high biotin levels may come from supplements taken based on physician recommendations, for example patients with multiple sclerosis.
It’s the test interference, not biotin itself
In response to FDA’s alert, the Council for Responsible Nutrition, a dietary supplement trade group, released a statement in which senior vice president of scientific and regulatory affairs Duffy MacKay, N.D., said that the organization “appreciates FDA taking seriously its responsibility of monitoring the Serious Adverse Event reporting system (SAERs).”
CRN also emphasized that the alert does not concern any health concerns with biotin supplementation, and that the FDA raised concerns “specifically directed to potential interference with certain lab tests.”
“In fact the Food and Nutrition Board of the Institute of Medicine was unable to establish Upper Levels for biotin because there is no evidence in humans that biotin is toxic at high intakes," MacKay told NutraIngredients-USA. "The issue here is that supplementing with biotin can interfere with a specific laboratory technology and interfere with test results. The solution is to stop biotin supplementation prior to getting blood work.”
MacKay recommends healthcare practitioners to alert patients to temporarily stop taking their biotin supplements before getting blood work.
For now, the FDA said that it is “working with stakeholders to better understand biotin interference with laboratory tests, and to develop additional future recommendations for safe testing in patients who have taken high levels of biotin when using laboratory tests that use biotin technology.”