Conclusions

The Expert Report identifies several areas where changes are needed to further encourage the development of functional foods. The following recommendations are particularly critical: Expand research into traditional nutrients, other bioactive food components, and the intersection of genomics and molecular nutrition. Continued basic and applied nutritional research must further explore the roles and mechanisms of action for traditional nutrients. In addition to traditional nutrients, other bioactive food components with the ability to improve health must be identified and their efficacy proven. The intersection of genomics and molecular nutrition presents opportunities for more definitively understanding diet and health in individuals and population groups, with the potential for personalized diets for optimal health.

Expand research on biomarkers and physiological endpoints. Additional biomarkers that signal changes in health status are urgently needed, and the meaning of changes in those biomarkers must be clearly demonstrated relative to a defined health condition. Research is needed to expand the validated biomarkers of health status including assessing how genes and gene products relate to disease risk.

Use generally recognized as efficacious (GRAE) panels to evaluate health claims and streamline the regulatory approval process. Good science is the foundation for health- and nutritionrelated claims. A GRAE panel composed of scientists with in-depth knowledge of the particular subject area would use the Hill criteria to evaluate the evidence and prepare a publicly available, comprehensive report of their findings. FDA implementation of the GRAE concept would provide a more predictable regulatory process. Because the generally recognized as safe (GRAS) notification procedure implemented in 1997 has proven to be both effective and efficient, FDA should establish a similar procedure whereby a GRAE report would be received and reviewed.

Allow product labeling and health claims to accurately reflect the scientific data without triggering drug status. Attempts to avoid classification as a drug have resulted in misleading (if not outright false) statements of the underlying science. Enormous public health benefits would result from having consumers clearly understand and act on the accurately claimed product benefit.

Modify the current definition and application of the term “nutritive value.” Given the current interpretations of applicable statutes and advancements in nutritional sciences, it is appropriate to replace “nutritive value” with a more inclusive definition. Benefits for functional foods should be based on nutritive value or through the provision of a physical or physiological effect that has been scientifically documented or for which a substantial body of evidence exists for a plausible mechanism.

Allow health claims based on significant scientific agreement (SSA) and qualified health claims based on the weight of the scientific evidence (WOSE). The ultimate success of functional foods will depend on delivering bioactive components in a predictable and assured manner to effectively reduce the risk of disease and/or improve body structure or function. To achieve this goal, FDA should allow health and nutrition claims that are truthful, nonmisleading, and consistent with available science, including qualified health claims. To this end, SSA and the WOSE approaches are valuable assessment methods. FDA should not allow claims when the scientific basis is very limited and supported only by preliminary studies.

Indicate the degree of scientific certainty for approved and qualified health claims. Appropriate qualifying language should clearly indicate the degree of scientific support or certainty associated with a biological effect or modification of disease risk. FDA’s interim guidelines for qualified claims provide limited language options for claims with varying levels of scientific evidence. The Agency is encouraged to allow flexibility in language, when equivalent language can communicate effective messages that adequately qualify the level of science supporting such claims.

Develop incentives for companies to invest in functional food research and development. The lack of exclusivity of health claims discourages companies from investing in functional food research. Incentives such as a period of exclusivity or tax incentives would encourage food companies to pursue functional food development as a profitable venture.

Use health claims on food labels as the foundation for consumer education regarding dietary components for health. Consumer education is an important component of the success of functional foods. Accurate claims on food labels help consumers select products that satisfy their desire to promote self-care and improve health. All food communicators, including food scientists and health professionals, must work together to improve consumer education by accurately characterizing new scientific developments.

The future development of functional foods will require contributions from basic and applied scientists in academia, government, and industry. Consumers want and need these products, and mechanisms must be found to foster their availability.


Recognizing the tremendous health benefits offered by functional foods, the Institute of Food Technologists commissioned an expert panel to review the available scientific literature related to functional food development. The panel’s report is divided into nine sections: Definitions, Introduction, Food and Genes, Current Legal Standards, Scientific Standards, Policy Limitations, Bringing Functional Foods to Market, Role of Research, and Conclusions. Copies of the report are available at www.ift.org. Founded in 1939, the Institute of Food Technologists is an international not-for-profit scientific society for food science and technology.