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Many would argue that all foods are “functional” because they contribute to nutrition in one way or another. However, nutritional and regulatory communities require “functional foods” to take a step beyond that definition. The Washington, D.C.-based International Food Information Council Foundation (IFIC) defines “functional foods” as “foods that provide health benefits beyond basic nutrition.” These foods are consumed as a part of a varied diet, as regular food and at levels effective to achieve their health goals. But do consumers recognize that such a distinction in their food supply exists? IFIC has been tracking consumer awareness through quantitative data collected in surveys since 1998. It finds that 94% of consumers agree that certain foods have health benefits beyond basic nutrition, and 85% of Americans have some level of interest in learning more about functional foods. At least 79% of consumers are aware of the connection between calcium and osteoporosis, 54% are aware of the connection between antioxidants and cancer, and 35% are aware of the connection between soy proteins and heart health. Consumers’ range of knowledge, however, does not go very far beyond the “awareness” level, so the potential for an improvement in nutritional education is very high. Media coverage of nutritional issues has greatly improved over the last five years, but much remains to be done to improve consumer nutrition. The benefits to consumer well-being, as well as to the future of companies engaged in research on functional ingredients are enormous. IFIC believes that improved education is possible: It cites the success of media coverage regarding the relationship of increased calcium intake and a reduced chance of osteoporosis as a success story, stating that 91% of consumers believe in the efficacy of this interrelationship. How can the food industry build on this type of faith? IFIC says: “When communicating about functional foods, it is important to translate quality science into understandable and usable messages that meet consumer needs. The following are specific communication strategies.” This is definitely food for thought, and a good starting point for a discussion on where the industry is today and some of the potential claims for the future. This article will look at how regulations have progressed over the last 10 to 15 years, then discuss functional ingredients, both old and new, and how they have progressed toward established health claims. Claiming functionalityThe food industry throws around many terms to describe the market now known as “functional foods,” and the different rules established for foods versus dietary supplements have further misled the consumer. According to Natural Foods Merchandiser, June 2002, this $20 billion market has grown 24% to 39% annually, so the definitions and rules are important, as FDA well knows. FDA has long recognized two categories of food — conventional food and dietary supplements. FDA recognizes any conventional food making a health claim as a functional food and tightly controls the ability of companies producing functional foods to make such claims — all require agency approval. Claims approved by FDA through the Nutritional Labeling and Education Act of 1990 (NLEA) must be based on significant scientific agreement among experts regarding the relationship between the substance and a health condition. Accordingly, only 12 claims have currently met these stringent requirements. FDA later enacted the Dietary Supplement Health and Education Act of 1994 (DSHEA), which exempted dietary supplements from the rules applied to food-additive approval and allowed the use of “structure/function” claims without prior FDA approval. With this, a company can make a statement such as: “Helps support cartilage and joint function.” This claim does not link a product’s functionality to a specific disease — if it did, FDA would regulate the product as a drug. Restating the requirementsNaturally, some companies chose the fast and easy route to market through DSHEA rather than the long approach to establishing an approved health claim. FDA gradually became increasingly concerned by the proliferation of unsubstantiated and misleading claims being made by certain unscrupulous dietary-supplement marketers. With this in mind, FDA issued a letter on Feb. 5, 2001, to restate the requirements for marketing conventional foods containing novel ingredients, including botanicals, under DSHEA. In this letter, FDA clearly defines the difference in claims under three designations. Health claim. This category defines a claim that characterizes the relationship between a food substance and a disease or health-related condition.
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The Facts on Functional Foods
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