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Establishing the evidence for health claims involves reviewing the available body of scientific knowledge and linking this to statements meaningful to consumers. This requires an understanding of scientific merit as well as consumer perceptions of health messages. Food Standards Australia New Zealand sets standards for current nutrient content claims and is close to approving a proposed new framework for all forms of nutrition and health claims on foods.

This article discusses this proposed health claims standard in light of the challenges health claims pose to nutrition science. It critically describes the framework for the standard, reviews issues related to substantiation of claims, and provides commentary on the proposed assessment of evidence. This spectrum of permission reflects the use of food in health promotion, disease prevention, and early disease management when therapeutic agents may not be required.

The position is consistent with an understanding that food delivers nutrients and bioactive substances at levels that support the improved health of the human organism in the early stages of the health-disease spectrum. Increasing knowledge of the role of food components and its intelligent application in dietary modification can result in this strategy playing a major role in disease prevention and early disease management.

The amount of evidence required to enable health claim labeling should be based on a reasonable judgment and clear understanding of the role of nutrition in health and disease

The importance of diet as an environmental exposure cannot be underestimated, and it behooves the health community to ensure that the increasing knowledge of nutrition science is translated to practice through healthier foods and food advice in both public and commercial domains. The benefits to the consumer can be seen through examining the differences between food and drug approaches as revealed by substantiating the efficacy and health benefits of foods.

In summary, there is much for the research community to consider in developing methodologies for dietary interventions to substantiate health claims for foods, but there is very good reason to do so.

Assessment of evidence

Although the science reported in the literature and reviewed in evidence-based assessments for health claims may not be specifically designed to provide evidence for food-based interventions, there is opportunity to draw on a large body of science accumulated over some 50 y to provide both theoretical and practical positions on the health efficacy of food. The application of this assessment in making judgments on health claims, however, needs to be put in perspective. The level of proof required should vary depending on the consequences.

Sources of evidence currently under discussion are authoritative reviews and texts and systematic reviews of the evidence. There are a number of ways of conducting systematic reviews, but a quality assessment of evidence will require degrees, such as high, medium, or low, of addressing study design criteria such as inclusion of a control group, dietary assessment, statistical quality, and appropriate outcome measures.

Currently a number of nutrition claims relating to nutrients and fiber, the indigestible component of plant foods, are listed under the old National Food Authority Guidelines for Food Labeling (16), and these include statements such as "thiamine helps release energy from carbohydrate," "iron aids in red blood cell formation," and "protein builds and repairs tissues in the body."

In preparation for the new proposed framework, the food standards authority has commissioned reviews for a number of potential high-level health claims, resulting in 5 proposed preapproved claims relating to sodium, with and without potassium, and hypertension; fruit and vegetables and coronary heart disease; saturated fat, with and without trans fat, and elevated serum cholesterol and heart disease; calcium, with and without vitamin D, and osteoporosis; and folate and neural tubal defects (1). Evidence was also accepted for a general-level claim for (n-3) fatty acids and heart health.

Details of the review papers are made public and reveal the means by which judgments were made as to the quality and quantity of evidence (1). This sets the path for any further proposals that groups may put forward for health daims consideration.

The imminent health claims framework to be adopted through FSANZ will position the use of food in health promotion through a set of categories of claims. These will allow 1 ) general statements of nutrient content and function, and of risk reduction in health conditions where medical assistance need not be required, and 2) more specific statements relating to disease risk reduction and associated biomarkers where there may be overlap with medical care. Claims of disease treatment will not be allowed.

This spectrum of permission reflects the use of food in health promotion, disease prevention, and early disease management when therapeutic agents may not be required. The position is consistent with an understanding that food delivers nutrients and bioactive substances at a level that supports the human organism in the early stages of the health-disease spectrum. Increasing knowledge of the role of food components and its intelligent application in dietary modification can see this strategy play a large part in disease prevention and early disease management. The amount of evidence required to enable this process to occur should be based on a reasonable judgment and clear understanding of the role of nutrition in health and disease.