Scientific substantiation of claims in the USA: focus on functional foods.

Although functional foods are currently regulated the same as conventional foods by the US Food and Drug Administration (FDA) there is some concern that they should not be. One concern is whether functional foods can/should carry the same type of health and nutrition labeling claims as conventional foods. For example, the type of nutrient content claim that describes a level of the nutrient such as "good or excellent source" presents a problem for functional foods since these claims relate back to a standard value for nutrients (the daily value or DV). At this time the bioactive or functional components in a functional food do not have daily values so they could not take advantage of this type of claim. Structure/function claims are also at issue since they are required to relate to the food's attributes of taste, aroma, and nutritive value, rather than attributes of functionality (which would pertain to functional foods). There appear to be three categories of issues concerning the regulation of functional foods: safety; efficacy; and their effect on the overall diet. Since bioactive components can be synthesized or extracted and concentrated, the concern is that the amounts of these substances in functional foods might reach levels which are actually injurious to health or they may negate beneficial effects of substances in the same food. Most people/organizations consider that functional foods need to document their functionality. This means that unlike conventional foods, all functional foods, by definition, would have to apply for a health claim. Finally, the long term overarching concern is what will be the impact of a functional food-driven market on overall health. It is of interest to see how the regulatory environment for functional foods evolves in the next few years and what impact that environment has on the future of these foods.