Debating Health Claims within Codex Alimentarius

In the mid-1980s, functional foods were introduced in Japan. These products were based on the concept that food and drugs have same origin. Since then, the market for functional foods in Japan has increased and has been extended into the international market. The global market for functional foods is expected to be approximately $17 billion in 2000 and to rapidly expand in the 21st century (Hickling, 1997).

Despite this expansion, the present regulatory system in most countries has not been updated to cope with the functional foods market. Regulations on functional foods have only been introduced in Japan. In some countries, including the U.S., regulations on health claims have been established. However, the implications for functional foods were not adequately considered in these regulations. 

At the international level, the recommendations for health claims have been discussed in the relevant committees of the Codex Alimentarius Commission. In the 27th Codex Committee on Food Labeling (CCFL) in 1999, claims reflecting the concept of functional foods were introduced into draft recommendations. The recommendations were further discussed in the 28th CCFL meeting in May 2000 (CCFL, 2000a). However, at present, the draft recommendations have been scheduled for further discussion and remain at step 3 of the 8-step Codex procedure. In spite of the significant progress, further discussions are required for the adoption of the recommendations. We have proposed that the various types of health claims from these regulations and proposals be incorporated into the following 6 categories (Kwak and Jukes, 1999):
· Nutrient content. These claims are related to the level of a nutrient contained in a food, such as high in fiber or low in fat.

· Comparative. This type of claim is related to the nutrient levels and/or energy value of two or more foods, such as reduced fat.

· Nutrient function. These claims relate to the physiological role of the nutrient in growth, development, and normal functions of the body. An example would be the function of calcium in the development of strong bones and teeth.

· Diet guidelines. These are a set of claims related to dietary guidelines or healthy diets.

· Enhanced function. These claims relate to specific beneficial effects of nutrients and non-nutrients on physiological or psychological functions or biological activities except nutrient function claims. They can be subdivided as: (1) claims relating to risk factors which may adversely affect good health, except nutrient functions (e.g., the maintenance of the level of serum cholesterol); (2) claims relating to the bioavailability of nutrients; (3) claims relating to the psychological impact (e.g., caffeine can improve cognitive performance); and (4) claims relating to the maintenance of a specific part or organ of the body (e.g., the regulation of intestinal flora).

· Reduction of disease risk. These claims refer to the reduction of the risk of a specific disease or condition either by an increase or a decrease of a substance. 

By examining the relationship between the claims, we can provide a better understanding of these claims and their relationship to functional foods’ proposed scope of health claims. 

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Science- and Consumer- Based Approaches
It is generally agreed at the international level that any claims should be demonstrated scientifically. However, with regard to the approaches to the classification of claims two different perspectives exist in view of the discussion in the Codex. In 1996, the classifications and definitions of both health claims and nutrient function claims were discussed at the Codex Committee on Food Labeling. Two alternative views were expressed: (1) some delegations expressed the opinion that a clear distinction could be made between health and nutrient function claims and between other different types of health claims (CCFL, 1996) and (2) other delegations, however, including the U.K. (Pascal, 1996) and Denmark (CCFL, 1998b), felt that the definitions should be merged, as no clear distinction existed between them and they were likely to confuse consumers (CCFL, 1996; 1998b; Pascal, 1996). 

Those taking the first view would consider scientific evidence as the primary factor in classifying claims. Scientific evidence has been internationally recognized as a decisive factor with respect to food trade, especially food safety. In any dispute relating to food safety in national or international food trade, where a large number of regulatory measures are in force, this criterion has played an important role in resolving disputes. They would expect that this approach could be followed in developing the regulation of claims. In practice, at the 27^th CCFL in 1999, the Proposed Draft Recommendation on Health Claims was based mainly on the classification developed by the International Life Sciences Institute (ILSI) Europe. This recommendation is based on the scientific classification of markers for target functions. The classification used by of the U.S. has been developed with this perspective. Five categories of claims are clearly distinguished in the U.S.: nutrient content claims, structure-function claims, classical deficiency disease claims, dietary guidelines, and health claims (Keystone, 1996). 

Those taking the second view considered that the recognition of claims by consumers should be a primary factor in their classification. This approach is strongly supported by consumer research. A consumer research report in the U.K. said that consumers were aware of nutrition claims and some health claims, but they made no distinction between them (NCC, 1996). A focus group study by the U.S. Food and Drug Administration (FDA) also reported that there was little or no recognition of health information given on labels as being distinct from nutrition information, ingredient information, or nutrient content claims (Keystone Center, 1996). 

Nutrient Function Claims
One of the issues relating to enhanced function claims is how to distinguish them from nutrient function claims. In other words, it is doubtful that the purpose or implication of nutrient function claims is significantly different from those of health claims, from both the consumer’s and the regulator’s point of view. 

Considering the consumer research mentioned earlier, the characteristics and impact of the messages delivered to consumers are not systematic. For example, it might be expected that consumers respond more positively to health claims than to nutrient content claims. If true, products bearing health claims would sell better in comparison to those bearing nutrient content claims or no claims at all. In order to test this, in 1997 FDA undertook consumer research (FDA, 1997). They set up the hypothesis that “the average health claim communicates positive attitudes about the product more effectively than a content claim.” However, the results indicated that “product-appropriate health claims had no effect, a positive effect, or a negative effect on respondents’ attitudes toward a product depending on the particular product.” Further, some other fundamental hypotheses for health claims also gave results different from the expectation. From this it cannot be concluded that delivering information on health benefits through health claims is the wrong approach. 

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According to the Codex proposed draft guidelines (CCFL, 2000a), nutrient function claims can be distinguished from enhanced function claims in two aspects. First, only the physiological role of the nutrient in growth, development, and normal functions of the body can be mentioned in the nutrient function claims. Second, the substances involved in a nutrient function claim should be only those nutrients for which a Nutrient Reference Value has been established in the Codex or those nutrients supported by the national dietary guidelines. However, the scope of the substances and functions claimed in these claims are much wider in that any foods, any constituents, or any functions can be related to enhanced function claims. 

Only the physiological role of the nutrient in growth, development, and normal functions of the body can be mentioned in the nutrient function claims. If that is the required basis, what are the growth, development, and normal functions of the body? This might be introduced into the guidelines based on the concept of traditional nutrition (i.e., the prevention of nutrition deficiency). In the Codex guidelines defining nutrient function claims, the antioxidant effect of vitamin E was given as an example (CAC, 1997). Vitamin E is certainly regarded as an essential nutrient. However, it would be questionable whether the claimed function—antioxidant effect—is considered as one of the growth, development, and normal functions of the body. 

Another example would be the level of cholesterol. The delegation of Denmark in the Codex stated that presently many countries consider claims related to blood cholesterol levels as nutrient function claims, while other countries consider these claims as health claims (CCFL, 1998b). 

Considering this ambiguity, nutrient function claims, which had been considered an independent category in the Codex (CCFL, 1999), were finally classified as a subcategory of health claims in the 28th CCFL meeting. 

National nutrition policies have been developed and are mainly based on the prevention of the absolute deficiency of essential nutrients. Since this is still an important health problem, nutrient function claims can be controlled as a subcategory of health claims. However, we believe that this differentiation will be unnecessary in the future, as nutrition research has revealed that essential nutrients as well as non-essential substances are important for better health. 

Enhanced Function Claims
Over half a century ago, the founders of the World Health Organization (WHO) defined the term health as a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity (WHO, 1998). People should be in optimum condition, not just avoiding medical treatment. 

As regards the classification of marker for functional foods, ILSI Europe considered two targets of functional foods (Diplock et al., 1999): (1) improved state of health and well-being; and (2) reduced risk of disease. This approach, including improved state of health and well-being, is appropriate, since not only disease but also well-being are certainly the objectives of health policy according to WHO’s definition of health. 

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Enhanced function claims are defined in the Codex as the claims that concern specific beneficial effects of the consumption of foods and their constituents in the context of the total diet on physiological functional or biological activities but do not include nutrient function claims (CCFL, 2000a). In view of these definitions and requirements, the boundary of the enhanced function claims seems to be clear. The examination of the claims already suggested or permitted would be helpful to better understand the scope of the claims. 

As summarized earlier, four types of function can be considered for enhanced function claims: (1) risk factor, (2) bioavailability, (3) psychological function, and (4) the state of a specific part or organ of the body. 

The claims on risk factor would be one of the internationally most popular types of claims. In the previous Codex draft recommendation on health claims (CCFL, 1994), they were already used as the examples of health claims relating to health-related effects on the body. In particular, this type of claim has a close relationship with reduction of disease risk claims. 

The claims on bioavailability would well match the category name of enhanced function claims, since the substances concerned really deal with the enhancement of the claimed function. This type of claim would be less controversial in comparison to other types, since it does not directly refer to a new function. The benefits of the substance concerned itself are unlikely to be an issue, although whether the effects are really improved can be controversial. In terms of this kind of function, the only claim allowed is for the improved adsorption of minerals in Japan. 

The claims on psychological function may be the most new and unfamiliar type of claims among these four types and were only mentioned in the report of ILSI Europe. Although the scope of health would justify these claims, this kind of claim has not yet been permitted even in Japan. One reason would be the difficulty in proving them with objective evidence. When the proposed recommendation for the use of health claims in the Codex was drafted on the basis of the proposals by ILSI Europe, it was questioned whether the term psychological could be incorporated into the definition of enhanced function claims. Ultimately it was excluded from the draft Codex Guidelines (CCFL, 2000b). 

The claims on the state of a specific part or organ of the body have already been permitted in Japan (KHFA, 1998) and are generally considered as one of the potential claims for functional foods by ILSI Europe (Diplock et al., 1999). They would also be recognized as a possible health claim in the U.K. code of practice on health claims on foods (JHCI, 1998) and as one of the structure/function claims by FDA (FDA, 1998). However, this type of claim is controversial at present, since there is not a consensus on whether the improvement of the state of a specific part or organ of the body means the improvement of health, more than just change of the physiological condition. 

Any states of a specific part or organ of the body, including the immune system and gastrointestinal system, can be applicable to the claims. A well-known example would be the relationship between prebiotics and the intestine. One of the claims approved in Japan stated that xylo-oligosaccharide is suitable to promote the growth of Bifidus bacteria and helps keep the body in good health (Japanscan Ltd., 1998). Clydesdale (1997) questioned the justification of that kind of claim. He said that “in this case a functional claim would relate to positive effects on gut physiology, but not on a particular disease or health effect.” Some other nutritionists also suggested the lack of scientific evidence on the health benefits of the increased number of Bifidus in the intestine. 

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It may be clear that scientific evidence is limited for this kind of claim in comparison to other claims on risk factors and bioavailability. In other words, these claims are supported theoretically by the definition of health, but currently lack sufficient supporting scientific evidence. 

Possible options relating to this case can be summarized as follows: First, the kind of claims should be allowed, since scientific evidence supports the change of the state of a specific part or organ of the body per se and scientific truth or fact should be communicated. Second, the claims should not be allowed, since the scientific evidence only supports the change of the state of a specific part or organ of the body, but not health benefits. 

The first approach may not be appropriate, since an ultimate aim of health claim labeling is to improve the health status of the population. Communication of scientific information may be meaningful between manufacturers and health professionals, but not between manufacturers and consumers. However, too strict an approach, such as the second, could impede the development of, and the investment by, industry, which results in no benefits for consumers. 

Therefore, in our opinion, expected benefits should be considered in this case, although they are not clearly supported by scientific evidence. If those benefits can significantly contribute to the health state of the population, the more positive approach may be necessary. As mentioned earlier, the consumer’s response to health claims is not as systematic as generally expected. In spite of this difficulty, health claims should be delivered to consumers. It is perhaps fortunate that claims concerning the state of a specific part or organ of the body (e.g., improvement of gut state) are likely to have less impact on consumers than the claims on risk factors (e.g., maintenance of cholesterol level). 

Reduction-of-Disease Claims
As implied by the terms used, reduction-of-disease-risk claims have a closer relationship with disease than enhanced function claims, since reference to the name of a disease can be made. Unlike the agreed-on scope of the claims, for which a definition has been adopted, there has been no consensus on whether this type of claim should be allowed. In the Codex, some countries such as Germany and New Zealand (CCFL, 1998b) supported the opinion of the U.K. suggesting that “all references to disease are deleted from the definition and example. . . . It is considered that mentioning disease should be outside the acceptable claim definition so as to avoid consumer misunderstanding” (Pascal, 1996). Consumer International also was of a similar opinion (CCFL, 1998b). 

DeFelice (1997) also agreed to the difficulty in distinguishing health claims from medical claims, although he insisted the medical claims of foods be encouraged. The prohibition of reference to disease is similar to the Japanese policy on FOSHU, where claims on risk factors such as blood pressure and cholesterol level are permitted without any reference to disease. 

On the other hand, the U.S. stated that “while the term ‘prevention’ of disease might [may] create some confusion, the claims allowed actually relate[d] to a reduction of the risk in a dietary context” (CCFL, 1998a). Other countries, such as South Africa, supported this view. This attitude was also supported by several industry organizations such as the International Council of Grocery Manufacturers Associations (ICGMA), the Confederation of the Food & Drink Industries of the EU (CIAA), and the International Dairy Federation (IDF) (CCFL, 1998c). 

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In our opinion, this issue is (as with discussion on GMOs) unlikely to be agreed on in the Codex, since the differences in opinion are very great. It will therefore have to be left at present to national authorities who will make the decision on this matter. If a particular disease is serious to their own population, the mention of the disease could be included as part of an active policy. If a certain disease is not serious to their own population, it would be better to avoid confusing the consumer and prohibit the mention of a disease in a health claim. 

The differentiation between a health claim and a medical claim has been agreed on internationally (CCFL, 1999). Unlike the case of reduction-of-disease-risk claims, the exclusion of claims relating to the prevention, cure, and treatment of disease and adverse health-related condition (i.e., medical claims), was agreed on in the Codex (CCFL, 1996). 

To clarify the scope of reduction-of-disease-risk claims, the term “risk reduction” was defined in the Codex proposal for health claims as “significantly altering a major risk factor(s) for a disease [or health-related condition]. . . . The presentation of risk reduction claims must ensure . . . by use of appropriate language and reference to other risk factors, that consumers do not interpret them as prevention claims”(CCFL, 2000a). 

This agreement exactly fits into the concept of functional foods. The reduction of disease risk is one of objectives of functional foods, but we have previously argued that the prevention of disease risk (i.e., medical claims) should be banned for functional foods (Kwak et al., 1999). This approach is in the Japanese policy on functional foods that requires that substances exclusively used as medicines are not allowed as functional foods. However, it does not mean that a food should not claim any medical benefits. If scientific evidence supports the medical claim of the food, it should be permitted and be considered as a medical food, but not as a functional food. 

Claims and Dietary Guidelines
Many national authorities have published dietary guidelines which have been important in their national nutrition policy. Dietary guidelines are a good tool for nutrition education in the implementation of a national nutrition policy to improve health. In this regard, claims related to dietary guidelines or healthy diet can play an important role. Therefore, it may be proper that the claims related to dietary guidelines or a healthy diet should be encouraged, be frequently used, and be subject to the minimum legal requirements. 

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Where the nationally recognized dietary guidelines consist of only a number of sentences, their implications for health claims would not be significant. However, where the volume of dietary guidelines is sizeable, as in the U.S., the simple quotation of dietary guidelines can consist of health claims in a number of cases. For example, the U.S. Dept. of Agriculture (USDA) and the U.S. Dept. Health and Human Services (HHS) published the Dietary Guidelines for Americans in 1995. These guidelines state that “most people are aware that high levels of saturated fat and cholesterol in the diet are linked to increased blood cholesterol levels and a greater risk for heart disease” (USDA/HHS, 1995). 

According to FDA’s two elements principle of health claims (Keystone Center, 1996), this sentence satisfies the condition of health claims, a specific nutrient—saturated fat and cholesterol—and a specific disease—heart disease. Therefore, FDA should consider this sentence as a health claim rather than a claim related to dietary guidelines. 

However, this principle was not adopted in the Codex proposal for health claims. In the proposal, health claim was defined as follows: any representation that states, suggests, or implies that a relationship exists between a food or a constituent of that food and health (CCFL, 2000a).

From these definitions, it can be recognized that any claims referring to the relationship between either a food itself, or a constituent of that food, and health should be regarded as a health claim. In other words, any labeling claim for a foodstuff can be a health claim if it refers to health benefits. For example, the claim that fruits and vegetables can be beneficial to your health is a health claim. In this regard, claims related to dietary guidelines or healthy eating would be difficult to exclude from the scope of health claims. Therefore, these claims should be incorporated into health claims. However, these claims may be distinguishable from other types of health claims, since they can involve other claims not referring to the function of substances or the name of a disease.

NO-SEONG KWAK AND DAVID JOHN JUKES
Kwak and Jukes are, respectively, Graduate Research Student and Lecturer, Dept. of Food Science and Technology, University of Reading, Whiteknights, Reading RG6 6AP, UK. Send reprint requests to author Jukes.

Edited by James H. Giese
Associate Editor

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