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.