Clarity Needed in Use of Biomarkers to Substantiate Food, Supplement Health Claims

WASHINGTONThe standards of science used by FDA in evaluating health claims for foods or dietary supplements should be no different than those used in assessing drugs, according to a new report from the Institute of Medicine (IOM), as all these products can have significant effects on peoples well-being. IOMs Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease recommended a new framework for FDA to use to consistently evaluate the health and safety claims based on stated effects of biomarkers and surrogate endpoints in chronic disease.

The evaluation framework, outlined in a report brief, involves three steps: analytical validation of the biomarker tests, qualification of evidence associating the biomarker with the disease, and utilization of the biomarkers as a surrogate endpoint if the evidence supports it. The committee tested the framework using case studies of biomarkers, such as cholesterol levels and their connection to cardiovascular disease. While the committee noted the use of biomarkers is critical to the regulation of food and drugs, there are concerns that the process is not harmonized and may require legislative adjustments to strengthen FDAs authority.

Specifically, the committee, convened by FDA's Center for Food Safety and Applied Nutrition (CFSAN), suggested Congress permit FDA to require further studies of drugs and devices after they are approved if their approval is based on studies using biomarkers as surrogate clinical outcomes. It also suggested granting FDA the authority to conduct studies of how well consumers understand food and supplement health claims and requiring manufacturers to make changes if needed to promote greater clarity.

Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medications, and this committee thinks that should in fact be the case, said committee chair John Ball, executive vice president, American Society for Clinical Pathology, Chicago. Without changes in the way biomarkers are used and assessed, however, health care providers, regulators and consumers will not be able to reliably collect or judge information to support claims.

However, the committee may have gone outside its bounds in making its regulatory recommendations, according to Daniel Fabricant, Ph.D., vice president of scientific and regulatory affairs, Natural Products Association (NPA). There is valid need to use surrogate biomarkers where no mechanism of action has been identified in how certain foods or nutrients affect certain disease states, he said. We need to find a way to bridge the gap when we dont see a clear mechanism of action but can see beneficial health effects from nutritional ingredients and foods. Biomarkers can give us an idea of this, and trying to see foods through the same lens as isolated pharmaceuticals is impractical from a policy standpoint.

Andrew Shao, Ph.D., senior vice president scientific and regulatory affairs, Council for Responsible Nutrition (CRN), attended one of the committees three meetings, held over the last 18 months, and said from the start it appeared the committee thought food policy and regulation was within their purview. In fact, CFSAN laid out a mandate as the agency is looking for more biomarkers to rely on as surrogate endpoints for chronic disease to allow for more health claims, he said. Ultimately, the committee completed a great framework to validate these biomarkers, but went ahead and dove into areas that were outside of the scope of what they were equipped to do. He added one of the committee members, Ronald Krauss, M.D., will be participating in CRNs Annual Day of Science, set for Sept. 29 in Austin, Texas.