Barbara Petersen

On December 5, 2006, I testified on behalf of the Institute of Food Technologists at the Food and Drug Administration’s "Public Meeting on Conventional Foods Being Marketed as ‘Functional Foods.’"

The testimony was based on the 2005 IFT Expert Report, Functional Foods: Opportunities and Challenges, prepared by the IFT Expert Panel. The complete testimony and report are available at The following is a summary of the testimony:

IFT believes that a few changes in regulatory policies could provide very positive benefits to society. But that is not to say that IFT believes that all foods on the market for which claims are being made are being properly represented based on science and proper regulatory policies. IFT does not support some claims on foods marketed today because they are not supported by today’s science.

Today’s science and technology can provide many additional functional foods, and future scientific and technological advances promise an even greater range of health benefits for consumers. Functional foods can provide health benefits by reducing the risk of chronic disease and by enhancing the ability to manage chronic disease, thus improving the quality of life.

Current policies limit addressing the full scope of benefits and potential developments of functional foods. The existing terminology and regulatory frameworks limit the scope and accuracy of consumer information and hinders development and marketing of functional foods. Convoluted wording of claims designed to avoid drug classification may lead to inaccurate conveyance of the actual effect of the food or misleading statements of the underlying science.

Current FDA policy requires that health benefits attributed to a food be derived from its "nutritive value" for the food to be exempt from regulation as a drug. This policy unduly restricts the health effects of foods to the limited concept of nutritive value and appears to be inconsistent with the courts’ interpretation of the Federal Food, Drug, and Cosmetic Act.

The IFT Expert Panel recommends that FDA policy not require claims about health effects of foods on normal health structure or function of the body to be based on the very limited concept of nutritive value. Rather, the Panel supports basing structure/function health claims on broad-based scientific criteria that address the underlying link between health and nutrition and meet the need for sound scientific substantiation supporting the structure/function effect. The Panel recommends that FDA apply a more appropriate policy—that health-claim benefits for functional foods be based on nutritive value or the provision of a physical or physiological effect that has been scientifically documented or for which a substantial body of evidence exists for plausibility.

The Panel supports scientifically defensible health and nutrition messages in the marketplace and therefore supports the concept of qualified health claims. The Panel recommends that FDA prohibit claims relying on very limited and preliminary studies and develop guidelines that protect consumers from limited scientific information of no meaningful value.

In general, the safety of functional foods should be based on the long-standing principle that foods are safe. Further, the safety assessment should accept the safety of components already established through generally recognized as safe (GRAS) determinations and food additive approvals.

The Panel recommends that independent expert panels be established to make generally recognized as efficacious (GRAE) determinations. These panels would be composed of respected scientists qualified to determine efficacy of the component under consideration. The Panel believes that such panels would encourage public confidence in the labeling of functional foods and would conserve government resources.

In summary, the IFT Expert Panel recommends (1) expanded research into traditional nutrients, other bioactive food components, and the intersection of genomics and molecular nutrition; (2) expanded research on biomarkers and physiological endpoints; (3) use of GRAE panels to evaluate health claims and streamline regulatory process; (4) allowing structure/function and health claims in product labeling to accurately reflect the scientific data without triggering drug status; (5) modifying the current definition and application of the "nutritive value" requirement; (6) allowing health claims based on "significant scientific agreement" and qualified health claims based on "weight of scientific evidence"; (7) indicating the degree of scientific certainty for approved and qualified health claims; (8) developing incentives for companies to invest in functional food research and development; and (9) using health claims on food labels as foundation for consumer education regarding dietary components for health.

by Barbara Petersen,
Ph.D., a Professional Member of IFT, is Principal, Exponent Food & Chemicals Group, Washington, DC 20036
([email protected]).