WASHINGTON -- The U.S. Food and Drug Administration (FDA) should apply the same rigor to evaluating the science behind claims of foods' and nutritional supplements' health benefits as it devotes to assessing medication and medical technology approvals, says a new report from the Institute of Medicine. There are no scientific grounds for using different standards of evidence when evaluating the health benefits of food ingredients and drugs given that both can have significant impacts on people's well-being, said the committee that wrote the report. It recommended a new framework the agency can use to consistently and transparently judge the appropriateness and validity of the scientific benchmarks used in studies that companies provide to support health and safety claims for their products.
Because it can be time-consuming and difficult to test products against actual clinical outcomes -- such as whether they cure or reduce the risk of a disease -- companies often conduct studies measuring effects on biomarkers, which are used as biological yardsticks or substitutes for clinical outcomes. For example, tumor size is used as a way to measure a cancer drug's effectiveness. Blood level of harmful cholesterol is often used as a biomarker for the risk of heart disease, and drug and food companies make claims about the heart health benefits of their products based on their ability to lower cholesterol levels, even if the products have not been shown to actually decrease heart disease.
FDA has been hampered in its ability to assess the proliferation of health claims being made by food and supplement manufacturers in part because it lacks a process broadly accepted across the regulatory, food, and medical communities to evaluate biomarkers as valid and appropriate measurements to substitute for clinical outcomes. The committee's proposed three-part framework gives the agency a way to consistently and rigorously assess the selection and use of b
|Contact: Christine Stencel|
National Academy of Sciences