Bringing Functional Foods to Market

The Expert Report presents a sevenstep process that addresses critical aspects in the design, development, and marketing of functional foods. Although all seven steps will be undertaken for each new bioactive substance and the resulting functional foods, the specific requirements within each step will vary depending on the physical, chemical, and biological characteristics of the functional component, the applicable regulatory requirements, and the health claims to be made.

Step 1: Identify the relationship between the food component and the 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). A wealth of scientific literature describes the types of research that can be used to identify potential relationships between functional components and health benefits.

Step 2: Demonstrate efficacy and determine the intake level necessary to achieve the desired effect. First, researchers attempt to identify the bioactive components that result in the health benefit observed in Step 1. In some cases, the bioactive component may be unidentified or partially identified. Sometimes the chemical identity is unknown, and a defined surrogate compound is used to establish efficacy. Next, the stability and bioavailablity of the component(s) must be demonstrated. This analysis includes the physical and chemical form of the food component, the effects of the total diet, the effects of food processing, and the effects of environmental factors during crop production. Stable and bioavailable components also must produce the identified health benefit.

To establish a credible health claim, the evidence of efficacy must be critically evaluated for adequacy based on the following: strength of association; consistency of the observed association; specificity of the association; temporal relationship of the observed association; dose–response relationship; biological plausibility; and coherence of the evidence. In applying each of these criteria to the research findings, consider also the amount and type of evidence, the quality of the evidence, the totality of the evidence, and the relevance of the evidence to the specific claim.

To receive a health benefit from consuming a functional food, the food 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-intake 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, including the potential for allergenicity.

Step 4: Develop a suitable food vehicle for the bioactive component. The food vehicle must be appropriate for the intended consumer and deliver the bioactive component at the desired compliance levels. The food vehicle must be consumed at the level necessary to achieve the benefit, but not consumed at amounts 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 scientific sufficiency of the evidence for efficacy. The evaluation of efficacy will be most effective and cost-efficient if undertaken by panels of independent scientists with appropriate expertise. This approach has been successfully applied to Generally Recognized as Safe (GRAS) determinations for many substances. A parallel process 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 that used for GRAS substances.

Step 6: Communicate benefits to consumers. The results of steps 1–5 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. Guidelines developed by the International Food Information Council Foundation and IFT ( guidelines/index.cfm) provide information about how to appropriately communicate scientific information to consumers.

Step 7: Conduct in-market surveillance to confirm 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.

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 Founded in 1939, the Institute of Food Technologists is an international not-for-profit scientific society for food science and technology.