For purposes of the Expert Report, Functional Foods: Opportunities and Challenges, functional foods is defined as foods and food components that provide a health benefit beyond basic nutrition (for the intended population). Examples may include: conventional foods; fortified, enriched, or enhanced foods; and dietary supplements.
Functional foods provide essential nutrients beyond quantities necessary for normal maintenance, growth, and development, and/or provide other biologically active components that impart health benefits or desirable physiological effects.
The Healthcare Paradigm
While food has long been used to improve health, our knowledge of health is now being used to improve food.
Functional foods fit into a continuum that ranges from health maintenance/promotion to disease treatment. Science has clearly demonstrated additional dietary roles in reducing disease risk, and consumers have learned that food has a greater impact on health than previously known.
Functional foods should be integral components of established health programs to reduce the risk of specific diseases while enhancing consumer control and minimizing cost.
Interaction of Food and Genes
The insight gained from genetic research provides opportunities to prevent disease and improve quality of life through functional foods. Genetic discoveries make it possible to understand the effects of nutrients in processes at the molecular level in the body and also the variable effects of dietary components on each individual.
The disciplines of nutrigenomics, proteomics, and metabolomics; as well as bioinformatics, a tool that uses computer database technology to integrate data from multiple disciplines, will contribute to the rapid development of functional foods.
Regulating Health Claims
Regardless of the type of claim, all food-labeling statements must be truthful and not misleading in any particular as required by the Food, Drug and Cosmetic Act. FDA evaluates health claims using a standard of significant scientific agreement (SSA).
In December 2002, FDA announced that it would consider allowing qualified health claims that would be evaluated using a weight of the scientific evidence (WOSE) standard. Different levels of scientific evidence would trigger qualifying language that describes the evidence supporting the claim.
Structure/function claims, which describe the dietary impact of the substance on the structure or function of the human body, may not claim to treat a disease or its symptoms, and they must not trigger some other requirement for FDA preclearance.
The Expert Panel took issue with the restrictive nature of structure/function claims, noting that sometimes compliance with the regulations results in misleading (if not outright false) statements of the underlying science.
To avoid drug classification, some claims may not accurately convey the actual effects of the food and may confuse consumers. Product labeling and health claims should be allowed to accurately reflect the scientific evidence.
Another area of current controversy is FDAs policy regarding nutritive value, which requires that the health benefit of a food component be derived from the nutritive value. FDA states, in 21 CFR 101.14(a)(3), that nutritive value means a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy.
The Expert Panel recommends that the benefits for functional foods 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.
Bringing Functional Foods to Market
The Expert Panel identified a seven-step process that will address critical aspects in the design, development, and marketing of functional foods.
Step 1: Identify relationship between food component and health benefit. The future success of functional foods relies on establishing a sound scientific basis for the relationship between a functional food and the claimed health benefit(s).
Step 2: Demonstrate efficacy and determine intake level necessary to achieve desired effect. The stability and bioavailablity of the component(s) must be demonstrated and produce the identified health benefit.
Functional foods must be consumed in adequate quantities to achieve the desired effect. Dietary intake assessments must address intake levels for the targeted population, potential high and low consumers, and population subgroups with special risks or benefits.
Step 3: Demonstrate safety at efficacious levels. Functional components must be determined to be safe at their projected-use levels, using an objective, science-based evaluation process. The assessment of safety should be based on the long-standing principle that foods are safe.
As such, the prior safe use of the component should play an important role in the demonstration of safety. Substances new to food use must undergo a safety assessment.
Step 4: Develop suitable food vehicle for bioactive component. A suitable food vehicle is appropriate for the intended consumer and delivers the bioactive component at the desired compliance levels.
The food vehicle must be consumed at the level necessary to achieve the benefit but not at levels so great as to be toxic. In addition, the selection of a vehicle depends on the stability and bioavailability of the bioactive components in that particular food.
Step 5: Demonstrate sufficiency of evidence for efficacy. The Expert Panel believes the evaluation of efficacy will be most effective and cost-efficient if undertaken by panels of independent scientists with appropriate expertise.
A parallel process to Generally Recognized as Safe (GRAS) determinations should be used to establish efficacy, by conducting a review of the evidence demonstrating efficacy. The process could be called a Generally Recognized as Efficacious (GRAE) determination.
A GRAE determination would achieve public confidence while conserving government resources. The FDA should establish a procedure for GRAE notification similar to those used for GRAS substances.
Step 6: Communicate benefits to consumers. The results of steps 15 should form the basis of the messages used to inform consumers of the relationship between the consumption of the functional food and its intended benefits. The health claims should be accurate and not misleading.
Step 7: Conduct in-market confirmation of efficacy and safety. Once the functional food is on the market, its manufacturer should monitor the actual consumption patterns and, when possible, the resulting health benefit. In addition, information about any adverse effects should be collected.
Role of Research
Basic and applied research is necessary to identify the entire range of potential functional foods, from new roles for traditional nutrients to currently unidentified bioactive components to nutrigenomics applications.
Improved knowledge of biomarkers is essential to understanding and documenting the effects of functional foods. The Expert Panel supports efforts to develop a legal, ethical, and societal framework to address the availability and use of nutritional genomic data.
The research by a company required for a functional food to meet scientific standards for efficacy is a substantial investment, but the return on that investment is not exclusive to that company. Incentives such as a period of exclusivity or tax incentives would encourage food companies to pursue functional food development as a profitable venture.
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.