"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.

Source: National Academy of Sciences