Chapter 3
Developing Claims for Functional Foods R. E. Litov NutraTec, 3210 Arrowhead Drive, Evansville, IN 47720-2504 There are no forthcoming regulations for functional foods in the U.S.A. However, there are three regulatory categories within which they may be currently marketed: 1.) food, 2.) dietary supplement, and 3.) medical food. Food "health claims" are the most restrictive health messages, requiring the greatest commitment of time and resources for a new claim approval. Dietary supplement "nutritional support statements" have the most flexible language, but are the least persuasive. Medical food "dietary management claims" are the most compelling, but the products have limited application and need significant clinical research support. Although information on food labels does influence the buying habits of surveyed consumers, few use the health claims on food labels and most are skeptical about the health claims made. Reports on nutrition and health studies confuse consumers because of conflicting results. Therefore, to maximize the effectiveness of health messages for functional foods, they need to be 1.) clearly communicated to consumers and 2.) credible, ie., supported by adequate research that convinces consumers of the link between the bioactive agent and the health benefit.
The use of food for good health has been practiced since early humankind. Certain plants and their components have been used by shamans, medicine men, and witch doctors to treat or prevent a multitude of ailments. Ancient cultures of China, India, and around the Mediterranean Sea used cooling foods for treating hot diseases and warming foods for cold illnesses. This system of hot and cold foods to treat disease is still practiced today in many parts of the world. As modern science and technology advanced, food fortification was introduced in the mid-20th century. Iodine added to salt, vitamins A and D to milk, and B vitamins to flour are now common practice. In the 1990's, interest in a category of foods commonly called "functional foods" has grown. Functional Foods There is no universally accepted or legal definition of a functional food. A suggested general definition is as follows: "Functional food or beverage products contain safe substances, are promoted for health benefits beyond meeting nutritional needs of growth and maintenance, and are included in a diet." The additional health benefits that functional foods are being designed to provide include preventing and helping to treat disease, enhancing physical performance, and improving the quality of life. Kellogg's All-Bran may be considered one of the first functional foods. In 1984, this breakfast cereal was the first food product that publicized the relationship between foods and
©1998 American Chemical Society
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18 disease on its label. Because of its fiber content, it was promoted as part of a diet that could reduce the risk of certain kinds of cancer. The health message had been developed in collaboration with the National Cancer Institute. A controversy followed regarding the use of health messages with food products. This prompted activity that later resulted in changes in the food regulations with the passing of the Nutrition Labeling and Education Act of 1990. Product Claims Product claims are valuable to food manufacturers and marketers in promoting their products. They can be used effectively to differentiate a product from the many similar products in the highly competitive food industry. Health messages associated with products can further educate consumers about the relation between food and health, an important objective by government agencies. Also, product claims can help consumers make informed decisions in the choice of their foods and nutrient intake. Health messages for functional food products can be made depending on what ingredients and levels are used and how the product is positioned. An overview of the current regulatory categories within which such products can be positioned and the limitations and allowances for health messages are given in the next section.
Regulatory Categories for Functional Foods It is highly unlikely that new regulations will be forthcoming to establish a separate regulatory category for functional foods in the U.S. A. However, this should not discourage marketers from developing and commercializing functional foods. The advantages to using the current regulatory guidelines for food and health care products are a.) not having to wait for new regulations and b.) revising existing regulations to accommodate specific objectives of functional foods would be easier than developing new regulations from the beginning. Presently, a new functional food product may be eligible for regulatory status as a 1.) food, 2.) dietary supplement, or 3.) medical food. Because the drug regulatory route is so cost and time prohibitive, it is not included in this discussion. The basic differences among ,the three regulatory categories are highlighted below and in a table. This article is not intended to be a thorough review of the regulatory requirements. Deciding which regulatory route to follow is an important early step in developing new functional food products. The choice depends on many factors, including business goals and available resources. It should be realized that there are many areas within these regulations that are subject to interpretation. Much of the present uncertainty for functional foods will resolve as the Food and Drug Administration (FDA) begins to establish a clearer pattern of enforcement and as case law emerges. Health messages need substantiation from scientific and medical studies to establish clearly the link between the bioactive agent of a functional food and a health benefit. These studies may include epidemiologic, biological mechanism, and intervention trials. The extent of such scientific support depends on the regulatory category and language of the health message to be used. Ideally, at least two randomized, placebo-controlled, double-blind human intervention trials showing significant and clinically meaningful health benefits should be among the scientific support publications.
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Food. The Nutrition Labeling and Education Act (NLEA) of 1990 (7) for foods allow for three types of claims: 1.) nutrient content, 2.) structure-function, and 3.) health. Nutrient content claims characterize the level of a nutrient, based on a predetermined reference amount of the food product. Claims are permitted only for those nutrients listed in the NLEA and implementing regulations, which include calories, fat, cholesterol, sodium, sugars, and those with established Reference Daily Intakes. Examples of nutrient content claims include "low in fat" and "cholesterol free." Although allowed, structure-function claims are rare or not currently used by food marketers. Health claims are used with some food products, but have several limitations including: • The product must be safe (ie., an established nutrient or one with Generally Recognized As Safe or Food Additive status). • The product must be a natural source of at least one of six nutrients (ie., provide at least 10% of the Daily Value for vitamin A, vitamin C, iron, calcium, protein, or fiber). • The product must not exceed 20% of the Daily Value of risk-increasing nutrients (ie., fat, saturated fat, cholesterol, or sodium). • There must be "significant scientific agreement" of the health benefit with respect to the totality of the publicly available scientific evidence (which is determined by the FDA). • The model claim language is prescribed (the relationship to total diet is conveyed and no mention of product brand is allowed). Nine health claims have been approved for foods to date. Petitions for new health claims can be submitted, but getting approval is long, difficult, and costly. Food health claims are the most restrictive health messages of any of the three regulatory categories and require the greatest commitment of time and resources for a new claim approval. Dietary Supplement. The Dietary Supplement Health and Education Act (DSHEA) of 1994 (2) repositions a product as different from food, exempts it from food additive provisions, and allows for flexible product claims. A product must be labeled as a dietary supplement and cannot be represented as a meal replacement or a conventional food. Unlike foods, dietary supplements are allowed to use "nutritional support statements." There is no formal approval process, manufacturers only have to notify the FDA of the statement's use within thirty days after first marketing the product. There are four types of "nutritional support statements": 1.) classical nutrient-deficiency disease support (eg., vitamin C and scurvy), 2.) description of the intended role that the ingredient plays in affecting structure or function of the body (eg., calcium and bone structure), 3.) characterization of the mechanism by which the ingredient acts to maintain such structure or function (eg., selenium as an integral part of the active site in the enzyme glutathione peroxidase), and 4.) description of the effect on general well-being expected from consumption of the ingredient (eg., is soothing). Marketers may not make any reference to disease conditions when using these statements in labeling and advertising. In addition, the following must be prominently displayed on the label: "This statement has not been-evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease." Dietary supplement "nutritional support statements" have the most flexible language of the health messages in the three regulatory categories, but are the least persuasive. Medical Food. Medical foods are the least formally regulated of the three categories. A definition of medical foods is as follows: "A medical food is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional
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requirements, based on recognized scientific principles, are established by medical evaluation" (7). However, additional regulations are expected as an advance notice of proposed rulemaking was made in November of 1996 (3). Traditionally these products have been promoted through health care professionals and distributed to hospitals, nursing homes, and home health care with retail distribution in pharmacy settings. Medical food "dietary management claims" are the most compelling health messages of the three regulatory categories, but the products have limited application and need significant clinical research support. Table I. Comparison of Health Messages Typically Used
Point of Difference
Food
Dietary Supplement
Medical Food
Health Claim
Nutritional Support Claim
Dietary Management Claim
2. Approval
Preappoval
Notification
None, advanced notice of proposed rulemaking pending
3. Language
FDA prescribed
Flexible
Flexible
Significant scientific agreement
Truthful and not misleading
Clinically significant
1. Health Message
4. Claim Substantiation
Consumer Attitudes about Food and Labels Increasingly, consumers recognize the connection between diet and disease and many are willing to change their eating habits for better health. Food labels can inform consumers about food products and help them choose foods to realize healthier diets. Often neglected by marketers is the consumers' understanding of the health benefits of certain foods or ingredients and how they use the information given on food labels. Labeling and the health messages for products positioned as functional foods become more important in the marketing of these products to consumers. However, little research has been done in this area and only of a general nature. There is no published study of consumers' responses to specific labels and health messages of functional food products. The American Dietetic Association (ADA) conducted a national telephone survey of 807 adults to examine their attitudes and behaviors toward nutrition and health (4). They found that 49% of consumers were very or somewhat confused by news reports on nutrition. A similar survey conducted two years later in 1997 found that 27% of consumers are confused by all the reports which give dietary advice (5). Although consumers complain that there are too many conflicting studies that confuse them, many (51%) want to hear about new nutrition studies. The FDA conducted a national telephone survey of consumers to monitor the impact of the recent changes in food label regulations (6). When consumers were asked how they use food labels, 70% often use them to see how high or low the food is in certain nutrients. Only 33% used the label to see if something said in advertising or on the package is actually true. The part of a food label most frequently used often by consumers is the nutrient amounts, by 56% of those surveyed. The part of a food label least used often was health claims, by only 25% of
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consumers. When asked about the accuracy of label claims, only 31% of consumers said about all or most health claims are accurate. Interestingly, the nutritional information provided on food labels has changed the buying habits of consumers (5). Around half of those surveyed (56%) by the ADA in 1997 switched to a different brand of the same-item based on the label. In addition, 65% of consumers bought some foods more often because of the information on the label. In conclusion, information on food labels does influence the buying habits of consumers. However, few consumers use the health claims on food labels and most are skeptical about the health claims made. This may be due in part to consumers perceiving the claims as strictly advertising and not being adequately supported by facts or reviewed by an independent authoritative organization to be credible. Also, the reports on nutrition and health studies confuse consumers because of their often conflicting results. Thus, to maximize the effectiveness of health messages for functional foods, they need to be 1.) clearly communicated to consumers and 2.) credible, ie., supported by adequate research that convinces consumers of the link between the bioactive agent and the health benefit. Acknowledgments The author thanks Mary Alice Springer for technical writing assistance and John J. Bushnell for reviewing the regulatory content. Literature Cited 1. U.S. Congress. Nutrition Labeling and Education Act of 1990. 1990, P.L. No. 101-535.
2. U.S. Congress. Dietary Supplement Health and Education Act of 1994. 1994, P.L. No. 1033. 4. 5. 6.
417. Food and Drug Administration. Federal Register. 1996, 61(231):60661-60671. American Dietetic Association. Nutrition Trends Survey 1995. 1995, pp 1-7. American Dietetic Association. Nutrition Trends Survey 1997. 1997, pp 1-11. Levy, A. S.; Derby, B. M. "The Impact of the NLEA on Consumers: Recent Findings from FDA's Food Label and Nutrition Tracking System," Internal Report of the Food and Drug Administration, Consumer Studies Branch, Center for Food Safety and Applied Nutrition, January 23, 1996, pp 1-6.
