FAQ: What is Needed to Position Functional Foods as an Integral Part of Disease Risk-Reduction Public Health Programs

Are there Policy Limitations Hindering Development, Commercialization, and Consumers’ Use of Functional Foods?
Yes, a number of factors limit research and development, commercialization, and consumers’ informed use of functional foods to benefit their own health. Although the current legal and regulatory structure for food has served our society well, it has areas where existing requirements are not in keeping with today’s needs. Certain current policies limit the scope and accuracy of consumer information about functional foods; other policies hinder the development and marketing of innovative functional foods, denying consumers of those health benefits.

IFT’s Expert Report recommends immediate improvements in the regulatory oversight of new functional components to allow the government and industry to keep pace with the rapidly advancing science of functional foods, and consumers the ability to benefit from the results.

What are the Policy Limitations Impacting on Research, Development and Commercialization?
The research required for a functional food to meet scientific standards for efficacy and safety is a substantial investment, and commercialization of a functional food product requires substantial incremental investment. Currently, the return on those investments is not exclusive to the company that conducted the research and developed the initial regulatory petition.

What Needs to be Done to Overcome the Development and Commercialization Challenges?
Government investment in basic and applied research would promote the development of functional foods, but additional incentives are needed to reward private companies that pioneer new health claims.

The Expert Report points out that patents alone are inadequate economic incentives. Possible incentives warranting exploration include exclusivity, marketing lead time, and confidentiality. Without a period of exclusivity during which companies can earn a reasonable return on their investment, the private sector is unlikely to commit the resources necessary to develop a wide range of product choices representing the best that nutritional science and functional foods can offer. Further, legislative bodies should aggressively pursue tax deductions and credits for health and nutrition research. IFT’s Expert Panel also encourages the food industry to support funding for cooperative research, possibly through programs in which industry dollars are matched by government dollars to conduct relevant, peer-reviewed research.

Molecular nutrition research has established a drug-like role for nutrients; but current food regulatory frameworks do not readily accommodate drug-like effects from nutrients and/or personalized nutrient plans based on genetic testing. FDA must develop policies and practices that facilitate the identification of therapeutic effects of foods and enable commercialization of such products.

Is more research on functional foods needed?
Yes, although the scientific literature reports almost daily on new insight into the role of existing nutrients, additional research is needed in many areas to ensure that the emerging science continues to be valid and is rapidly translated into consumer-relevant products. IFT’s Expert Report identifies several research areas that are vital to the development of functional foods.

Key areas for research are:
• pursue more precise understanding of the mechanisms of action of known nutrients, their dose-response relationships, and individualistic clinical outcomes;
• identify new biomarkers (biological endpoints correlating with health status or exposure to specific food components), surrogate markers (relating directly to disease development [e.g., elevated levels of low density lipoprotein cholesterol for increased risk for coronary heart disease]), and exposure markers, for better indication of health status and to assess intake, bioavailability, and utilization of bioactive components in functional foods;
• identify and tailor ideal food vehicles and packaging for delivery of bioactive ingredients in foods that provide a stable environment for the substances, maintaining their bioavailability, and sensory characteristics desirable to consumers;
• update and expand food composition and component databases; and
• identify diet-responsive genes and single nucleotide polymorphisms, and validate that dietary interventions modify expression of the genes in ways that produce the desired health benefits.

What are the Policy Limitations Factoring into Consumers’ Ability to Benefit from Functional Foods?
Sometimes regulatory compliance results in misleading, if not outright false, statements of the underlying science. To avoid classification of a food as a drug, some claims (e.g., structure/function claims) on foods may not accurately convey the actual effects of the food and, hence, confuse consumers. For example, a claim that a food lowers cholesterol would be considered a drug claim because it implies abnormal cholesterol levels. Thus, functional foods that affect cholesterol levels state that the food “maintains normal cholesterol levels,” a permissible structure/function claim. However, such a statement is potentially misleading if the food in fact lowers cholesterol levels.

What Needs to be Done to Allow Consumers to Readily and Fully Benefit from Functional Foods?
The Expert Report recommends that product labeling be allowed to accurately reflect the scientific evidence. As long as claims are scientifically valid, enormous public health benefits would result from consumers understanding and acting on the claimed product benefit.

If “qualified” health claims are not adequately differentiated from “approved” health claims, consumers may be misled. Thus, the wording of qualified health claims 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 health 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.

Further, as FDA has indicated, a “weight of scientific evidence” standard, tempered by the “credible evidence” test, should be applied to qualified health claims. The Expert Report recommends that FDA prohibit claims relying on “very limited and preliminary studies” and develop guidelines that protect consumers from limited scientific information. Protecting the privacy of individuals may become an issue as we move into applying nutrigenomics to individualized diets. IFT supports efforts to develop a legal, ethical, and societal framework to facilitate personalized nutrition while safeguarding consumer privacy.

What Else is Needed for Public Health to Benefit from Functional Foods?
Current FDA policy requires that the health benefit attributed to a food component be derived from its “nutritive value.” The Expert Report recommends that FDA not restrict the health benefits of foods to this very limited concept. Rather, IFT supports basing structure/function and health claims on a broad-based scientific criterion that addresses the extensive links between health and nutrition and other scientific disciplines such as physiology, endocrinology, biochemistry, neurology, and genetics. This recommendation is consistent with the desires of consumers, functional food manufacturers, and regulators alike, who all want credibility in the claims on food products. Regulatory oversight would be more consistent and appropriate if FDA replaced “nutritive value” with a more appropriate definition: “that benefits for functional foods should be based on nutritive value or through the provision of physical or physiological effect that has been scientifically documented or for which a substantial body of evidence exists for plausibility.”

The Expert Report identifies a seven step process that would address critical aspects in the design, development, and marketing of functional foods:

Step 1: identify the relationship between the bioactive food component and its health benefit;

Step 2: demonstrate efficacy and determine the intake level necessary to achieve the desired effect;

Step 3: demonstrate safety of the component at efficacious levels;

Step 4: develop a suitable food vehicle for the component;

Step 5: demonstrate scientific sufficiency of evidence for efficacy (and health claim accuracy) via independent peer review;

Step 6: communicate product benefits to consumers;

Step 7: conduct in-market surveillance to confirm efficacy and safety.

To address the myriad challenges facing the advancement of the use of functional foods to maintain or promote health and reduce disease risk, IFT’s Expert Report points out that innovative, paradigm-shifting approaches to nutrients and their role in health are required on a number of fronts, and funding to expand the knowledge base of molecular nutrition is needed.

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.