Widespread consumer use and the potential role of bioactive components in foods and supplements in health promotion and disease prevention are of public health interest. The Office of Disease Prevention and Health Promotion (ODPHP), Office of Public Health and Science, Department of Health and Human Services (HHS), acting on behalf of an ad hoc Federal working group have undertaken the tasks of defining bioactive components and exploring approaches to evaluating their significance in health promotion and disease prevention. The ad hoc Federal working group includes representatives from HHS, The Department of Defense (DoD), and U.S. Department of Agriculture (USDA), and agencies within these departments, such as the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and The Food and Drug Administration (FDA).The goal of this cross-agency effort is to stimulate discussion and research.

The objective of the March 24-25, 2005 "Assessing the Health Effects of Bioactive Food Components" Conference was to identify guiding principles that can be used to assess the health effects of bioactive food components. The conference was organized into six unique sessions. The first five sessions featured topic areas with experts from academia, industry, and government. The sixth session highlighted key information/insights that surfaced during the previous sessions. Specifically, the conference reviewed:

• Bioactive food components that deserve special attention and opportunities/challenges in characterizing their benefits when supplied as a food or supplement? In addition, identify what additional dietary, environmental, and genetic factors that must be considered when evaluating the efficacy of specific bioactive components for promoting health and associated biomarkers.
• Approaches for categorizing and assessing the health effects of bioactive components. Identify common principles in these approaches and evaluate their suitability to categorize and assess the health effects of widely diverse bioactive food components.
• Technologies that can be used to evaluate health and/or predict the onset and progression of disease. Discuss the appropriateness of these techniques to assessing the health effects of bioactive food components.

1. Should other approaches for evaluating the health effects of bioactive components in foods and supplements be considered?
2. What are some common principles in these approaches and are these principles suitable to categorize and assess the health effects of bioactive food components?
3. Do we need one approach or several approaches?
   • Foods, dietary patterns vs. isolated components, supplements.
   • Research, policy.
   • Evaluate potential beneficial and adverse effects.
4. Concluding statements that can be drawn from current scientific knowledge?
5. Recommendations for future research?

1. Are current animal models adequate for testing bioactive food components? How do you apply the data to human outcomes?
2. Challenges in identifying appropriate biomarkers and surrogate end-points; lessons learned from CVD. Is knowledge or identification of biomarkers essential to understanding and documenting the health effects of bioactive food components?
3. Is there a logical way for grouping and/or prioritizing dietary components that modulate the outcome of CVD? Can this scheme be applied to researching the effects of dietary components on other disease or health-related conditions?
4. Concluding statements that can be drawn from current scientific knowledge?
5. Recommendations for future research?

1. What are some characteristics of cancer disease models and how can these characteristics be applied to our understanding of other disease conditions and dietary components that modulate the outcome of these disease conditions?
2. Challenges in identifying appropriate biomarkers and surrogate end-points for cancer. Is knowledge or identification of biomarkers essential to understanding and documenting the health effects of bioactive food components? Are existing approaches adequate?
3. Is there a logical way for grouping and/or prioritizing dietary components to research their impact on cancer? Can this scheme be applied to researching the effects of dietary components on other disease or health-related conditions?
4. Concluding statements that can be drawn from current scientific knowledge?
5. Recommendations for future research?

1. Should the scientific considerations for the safety and/or efficacy of bioactive components in foods and supplements be the same or differ, and if so, how?
2. Is it necessary to identify the bioactive/physiologically active component(s) in foods/supplements to assess their health effects?
3. Given the thousands of potential bioactive food components, is there an efficient way to studying their health effects? What general structure or framework can we put in place to accomplish this?
4. How do you deal with natural variation or variability in foods?
5. How does one control for the matrix effect in studies?
6. Concluding statements that can be drawn from current scientific knowledge?
7. Recommendations for future research?

1. How do the complexities of systems biology and molecular techniques (genomics, proteomics, and metabolomics) affect current and future impact of these approaches for identifying potential health effects of bioactive food components?
2. Can a general structure or framework be developed for using these approaches to assess or predict human health effects?
3. Personalized/individualized nutrition: How feasible is this, given the current scientific knowledge.
4. Are there unique issues for systems biology and -omics research for extrapolation from animal/experimental models to human outcomes?
5. When do you move from sensitivity to specificity in research on molecular biomarkers? How do we know when we understand the biology well enough to select appropriate biomarkers?
6. What conclusions can be drawn from current scientific knowledge?
7. Recommendations for future research?