Washington, D.C., November 29, 2017—In response to a Food and Drug Administration (FDA) alert to public healthcare providers, lab personnel, and lab test developers, the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, issued the following statement:
Statement by Duffy MacKay, N.D., senior vice president, scientific & regulatory affairs, CRN:
“Biotin is a safe nutrient and FDA has not identified any health concerns with biotin supplementation. The concerns raised by FDA are specifically directed to potential interference with certain lab tests. The simplest and most effective way to address these concerns is for healthcare practitioners to alert patients to temporarily stop taking their biotin supplements before getting blood work. The take-home reminder for consumers is that it is always important for them to talk to their healthcare practitioners about all of the dietary supplements, over-the-counter products and prescription drugs they are taking in order to prevent interactions and lab errors.
We appreciate FDA taking seriously its responsibility of monitoring the Serious Adverse Event reporting (SAERs) system. CRN lobbied for the law which created mandatory reporting of SAERs because we understand it provides a way for the regulatory agency to identify signals and patterns that may indicate a potential safety issue. When this monitoring of adverse event data suggests a product may interfere with a medical test, as happened in this case, then it is important that this data be shared with the healthcare community and publicly. However, it is also important that the results not be over- or misinterpreted, resulting in concerns that go beyond the issue at hand.”
The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing 150+ dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. Visit www.crnusa.org. Follow us on Twitter @CRN_Supplements and LinkedIn.