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 biomarkers across the food, device, and drug areas.
In addition, the report calls on Congress to boost the agency's authority 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. And Congress should give FDA the authority to conduct studies of how well consumers understand food and supplement health claims and require 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."
The proposed framework entails validating that a biomarker can be accurately measured, ensuring that it is associated with the clinical outcome of concern, and confirming that it is appropriate for the proposed use. Committee members demonstrated the kinds of information and lessons the framework can provide by doing several case studies, looking at tumor size as a biomarker for cancer, blood level of beta-carotene as a surrogate for cancer and cardiovascular disease risk, and cholesterol level as an indicator of heart disease, among others.
The report calls for Congress to enhance FDA's abilities to study how health-related information can be communicated more effectively to consumers to help them better understand the science behind claims they see on packaging. The typical consumer is not aware that claims for food ingredients and supplements are often made based on studies using biomarkers instead of actual health outcomes, and that this introduces a measure of uncertainty.
FDA also needs the resources and authority to act on claims when they are found to cause confusion or to exceed regulatory limits. A report issued by Rep. Henry Waxman's office noted that FDA enforcement of food and supplement health claims declined by more than 50 percent from 2000 to 2005. However, recent actions by the FDA indicate it is engaging in heightened enforcement of food labeling, including health claims.
The report was sponsored by the U.S. Food and Drug Administration. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. A committee roster follows.
Copies of EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS IN CHRONIC DISEASE are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at HTTP:/
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INSTITUTE OF MEDICINE
Food and Nutrition Board
Board on Health Care Services
Board on Health Sciences Policy
COMMITTEE ON QUALIFICATION OF BIOMARKERS AND SURROGATE ENDPOINTS IN CHRONIC DISEASE
JOHN R. BALL M.D., J.D. (CHAIR)
Executive Vice President
American Society for Clinical Pathology
MICHELLE A. ALBERT, M.D., M.P.H.
Assistant Professor of Medicine, and
Associate Physician, and
Director of Behavioral and Neurocardiovascular Cardiology
Bringham and Women's Hospital, Harvard University
FRED APPLE, PH.D.
Department of Laboratory Medicine and Pathology
University of Minnesota Medical School;
Medical Director, Clinical Laboratories
Hennepin County Medical Center
ROBERT M. CALIFF, M.D.
Clinical and Translational Research, and
Duke Translational Medical Institute, and
Professor of Medicine
Division of Cardiology
School of Medicine
VICTOR G. DE GRUTTOLA, SC.D.
Chair and Professor
Department of Biostatistics
School of Public Health
DAVID L. DEMETS, PH.D.
Professor of Statistics and Biostatistics
Department of Biostatistics and Medical Informatics
University of Wisconsin
ROB GERSZTEN, M.D.
Associate Professor of Medicine
Cardiovascular Research Center
Massachusetts General Hospital
WILLIAM R. HARLAN JR., M.D., FACP, FACPM, FAAFP, FAHA
Chevy Chase, Md.
ALLAN S. JAFFE, M.D.
Professor of Medicine
Cardiovascular Diseases Division
Department on Laboratory Medicine and Pathology
College of Medicine
RONALD M. KRAUSS, M.D.
Children's Hospital Oakland Research Institute, and
Life Sciences Division
Lawrence Berkeley National Laboratory
HARLAN M. KRUMHOLZ, M.D., S.M.
Harold H. Hines Professor of Medicine and Epidemiology and Public Health
School of Medicine
New Haven, Conn.
MARIA LOPES-VIRELLA, M.D. PH.D.
Immunology and Microbiology Department
Division of Endocrinology, Diabetes, and Medical Genetics
Medical University of South Carolina
ROBERTA B. NESS, M.D., M.P.H.
Dean and M. David Low Chair in Public Health
School of Public Health
University of Texas
JENNY VAN EYK, PH.D.
Associate Professor of Physiology and Biochemistry
Johns Hopkins University
JOHN A. WAGNER, M.D., PH.D.
Merck and Co.
CHRISTINE MICHEEL, PH.D.
Office of Dietary Supplements
National Institutes of Health