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Smart Foods Centre, University of Wollongong, Wollongong NSW 2522 Australia
* To whom correspondence should be addressed. E-mail: ltapsell{at}uow.edu.au.
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ABSTRACT |
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 TOP ABSTRACT IntroductionLITERATURE CITED |
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Introduction |
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TOPABSTRACTIntroductionLITERATURE CITED |
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Given this context, there are particular challenges for nutrition science to define its role in food research and development. This article proposes that there are important issues that relate to the strategic directions of the scientific enterprise, the development of methodology, and the level of investment in science from multiple perspectives. The situation demands a revisit of the concept of nutrition itself. In particular, there is a need to consider the links among competencies of groups from multiple disciplines, the relative values of food components, whole foods, and whole diets, and the study designs and methods used to examine the concept of nutritional value.Ultimately, the nutrition science community must take a reflective step back to find ways of best forming a consensus on the translation of nutrition research to useful activity. One approach is to consider as a case study the current activity in health claims development in Australia and New Zealand.
Since passage of the Food Standards Australia New Zealand Act of 1991, these 2 countries have shared a food regulatory system under the statutory agency Food Standards Australia New Zealand (FSANZ). The food standards code (Standard 1.1A.2) regulates the current use of nutrient content claims and some general health maintenance claims, but it prohibits health claims relating to disease prevention, with the exception of folate and the risk of neural tubal defects. The newly proposed Nutrition, Health and Related Claims Standard (Proposal P293) contains standards for nutritional content claims, general-level health claims, and high-level health claims (1).
This article focuses on a review of the proposed health claims standard in light of the challenges that health claims pose for 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 based on the application of the proposed substantiation framework.
Health claims framework
Australia and New Zealand share common food standards managed through the authority of FSANZ. The proposed standard for health claims addresses foods and the representation of their nutritional or health benefits through general- or high-level claims. The approach of the standard is to remove ambiguity in the marketplace, provide a comprehensive framework, protect and assist consumers, provide opportunity for industry, have regard to costs, and work with community support (1). The framework of FSANZ focuses on the substantiation of different types of claims in a managed system while integrating current practices and allowing for a phase-in period. Importantly, this means that not all foods are treated as equal; that is, foods must first meet eligibility criteria based on their overall nutritional profile.
The claims framework is based on a risk assessment model that emerges with a principle of "do no harm" with a defining point of not addressing serious disease. Thus, although it is acknowledged that food is essential for life, there is still much to know about the underlying physiological mechanisms. In contrast, disease generally requires medical treatment, and health claims on food should not deter the consumer from seeking it.
General-level claims will be permitted, but users need to hold substantiation dossiers and submit them for review on request. They cover nutrient content claims and some low-risk functional claims related to nonserious diseases. Examples of these would be "maintain digestive health," "optimize hydration," or "boost concentration" (6). High-level claims will require formal preapproval. These claims relate to more serious conditions and cover biomarker and risk reduction claims. Examples include "lower LDL cholesterol" and "reduce risk of diabetes" (6). A number have already undergone review and assessment by the food standards authority for inclusion in the standard. So far, these relate to specific nutritional outcomes from calcium, vitamin D, sodium, folic acid, and saturated or trans-fatty acids. Consistent with the framework, therapeutic claims are prohibited.
Research has shown that the claims framework appears to reflect the practice landscape in food advertising. In surveys of food labels, internet sites, and print media, conducted on 3 different occasions and with different media and claims, most claims on food have been found to be at the general level, and this was most often the case on food labels (6–8), with print advertisements showing greater numbers of higher-level claims (Table 1).
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Thus, the claims framework is a legal process in which nutrition science has a role to play. The adoption of the "do no harm" model may suggest that the health benefits of food are not yet fully articulated. There is also the risk that not applying the knowledge of health benefits from foods in a claims framework may be detrimental to public health as well (9). A better understanding of food and human biology is emerging with current developments in nutrition science, but it is complex and far reaching (10). The health claims framework may provide strategic direction for this enterprise.
The identification of therapeutic and high-level claims in the media (Table 1) also suggests that although there appears to be an acceptance of the rules, which currently allow general-level claims, there are some exceptions. In society at large, rules constantly change with certain developments. For this reason, the framework will need to be suitably adaptable as scientific knowledge advances to incorporate such changes. The difference in language use between general- and high-level claims is of interest and probably has greater implications for the issue of substantiation because it means translating common language into scientific methodology, if in fact the methodology exists.
Claims substantiation
Providing an acceptable level of scientific evidence in support of the claim substantiation is 1 of 3 prerequisites for eligibility health claims under the food standards authority (1). The other 2 are 1) that the claims meet qualifying criteria (they are relevant to population health and refer to foods with high nutritional value) and 2) that wording conditions are satisfied (addressing the target population and the whole diet). Substantiation requires a systematic review of all the available evidence in humans and a quality assessment of the research. There is a need to establish a causal relation between the food and measurable health outcomes in the intended population and within an achievable whole diet context. This goal places certain conditions on study design (Table 2).
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The randomized controlled trial is the study design accepted as providing the ultimate proof of efficacy in trials of both therapeutic agents and behavioral strategies (5). Studies of efficacy of food lie somewhere in between, as they represent both agent- (bioactives) and behavior-derived (food choice) outcomes. This has implications for the design of the control group and questions the logic of a placebo product. Here efficacy refers to both consumption of the target food and making a choice between that food and another product. It thus seems reasonable to determine the "placebo" as an alternative product, not necessarily the same food with bioactive ingredients removed. The variable of interest is the food itself, and effects could be explained in terms of different ingredient composition. With whole-diet interventions, however, blind studies are achievable.
Our experience shows that close attention to dietetic detail is required to attribute the benefit afforded to a single food in the context of the whole diet (11,12). Reference to mechanistic research is also important in providing a theoretical position for suitable biomarkers and in providing direction to control for dietary variables in the whole-diet model. For example, in our study of the health benefits of walnuts in the diet for diabetes, we needed to work within a dietary model that addressed the macronutrient profile of the whole diet, demonstrating the critical position of the single food, such as walnuts, in meeting those targets (13).
The results demonstrated how individual foods deliver their benefits through significant positioning against other foods. This is an interdependent relation, but one that clarifies the concept of core foods. In this case, walnuts were highly significant in assuring a favorable ratio of fatty acids in a low-fat diet, an important factor in lifestyle-related disease (14). In addition, the food matrix of walnuts likely contributed to the positive outcomes through other essential and interdependent nutrients (15). In stark contradistinction to drugs, this is an example of how food delivers related health benefits. This example shows that although both lipid-lowering drugs and diet can modify the disease biomarker, the approach and conditions differ. In addition, the effect was seen in people newly diagnosed with diabetes and not yet on insulin therapy.
A further hypothesis developing from this experience is that, at least where lifestyle-related disease is considered, diet contributes to health in supporting the organism and preventing further development of dysfunction in the health-disease continuum. This helps to distinguish between the role of diet and drug therapy, where there might be some overlap and synergy.
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 claims 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.
Other papers in this supplement include references (17–26).
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FOOTNOTES |
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2 Author disclosure: L. C. Tapsell is the Director of the National Centre of Excellence in Functional Foods at the University of Wollongong, funded through the National Food Industry Strategy, an initiative of the Australian government Department of Agriculture Fisheries and Forestry. The Centre undertakes research with a full range of food industry bodies and national granting schemes. Professor Tapsell has done work with the Danone group on ‘Foods with Health Benefits’, Choices International, and the Scientific Advisory Council of the California Walnut Commission. The opinions expressed in this review are those of the author.
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LITERATURE CITED |
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TOPABSTRACTIntroductionLITERATURE CITED |
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1. Food Standards Australia New Zealand. Health and related claims [cited 6 July 2007]. Available from http://www.foodstandards.gov.au.
2. National Health and Medical Research Council. Dietary guidelines for Australians [cited 6 July 2007]. Available from http://www.nhmrc.gov.au/publications/synopses/dietsyn.htm.
3. Australian Government Department of Health and Aging. The Australian guide to healthy eating. Available from http://www.health.gov.au/internet/wcms/publishing.nsf/content/health-pubhlth-strateg-food-guide-index.htm.
4. Australian Government Department of Health and Aging, New Zealand Ministry of Health and National Health and Medical Research Council. Nutrient reference values for Australia and New Zealand. Available from http://www.nhmrc.gov.au/publications/synopses/_files/n27.pdf.
5. National Health and Medical Research Council. A guide to the development,evaluation and implementation of clinical practice guidelines [cited 6 July 2007]. Available from http://www.nhmrc.gov.au/publications/synopses/cp30syn.htm.
6. Williams P, Ridges L, Yeatman H, Houston A, Rafferty J, Roesler A, Sobierajski M, Spratt B. Nutrition function, health and related claims on packaged Australian food products—prevalence and compliance with regulations. Asia Pac J Clin Nutr. 2006;15:10–20.[Medline]
7. Dragicevich H, Williams P, Ridges L. Survey of health claims for Australian foods made on Internet sites. Nutrition and Dietetics. 2006;63:139–47.
8. Williams P, Tapsell L, Jones S, McConville K. Health claims for food made in Australian magazine advertisements. Nutrition and Dietetics. 2007;64:234–40.
9. Williams P. Health claims and functional foods; Time for a regulatory change. Aust J Nutr Diet. 1998;55:87–90.
10. Jacobs DR, Tapsell LC. Food, not nutrients, is the fundamental unit in nutrition. Nutr Rev. 2007;65:439–50.[Medline]
11. Gillen LJ, Tapsell LC. The development of food groupings to guide dietary advice for people with diabetes. Nutrition and Dietetics. 2006;63:36–47.
12. Gillen LJ, Tapsell LC, Patch CS, Owen A, Batterham M. Structured dietary advice incorporating walnuts achieves optimal fat and energy balance in patients with type 2 diabetes mellitus. J Am Diet Assoc. 2005;105:1087–96.[Medline]
13. Tapsell LC, Gillen LJ, Patch CS, Batterham MJ, Owen A, Bare M, Kennedy M. Including walnuts in a low fat/modified fat diet improves HDL:Total-C in patients with type 2 diabetes mellitus. Diabetes Care. 2004;27:2777–83.
14. Diet WHO. Nutrition and the prevention of chronic disease. Geneva: World Health Organisation; 2003.
15. Tapsell L, Gillen LJ, Patch CS. Walnuts and dietary approaches to the prevention and management of abnormal lipid profiles in Type 2 diabetes mellitus. Future Cardiology. 2005;1:809–14.
16. National Food Authority. Guidelines for food labelling. Canberra: National Food Authority; 1993.
17. Jones PJH, Asp N-G, Silva P. Evidence for health claims on foods: how much is enough? Introduction and general remarks. J Nutr. 2008;138:1189S–91S.
18. Yamada K, Sato-Mito N, Nagata J, Umegaki K. Health claim evidence requirements in Japan. J Nutr. 2008;138:1192S–8S.
19. Yang Y. Scientific substantiation of functional food health claims in China. J Nutr. 2008;138:1199S–205S.
20. Asp N-G, Bryngelsson S. Health claims in Europe: New legislation and PASSCLAIM for substantiation. J Nutr. 2008;138:1210S–5S.
21. Hasler CM. Health claims in the United States: An aid to the public or a source of confusion? J Nutr. 2008;138:1216S–20S.
22. L'Abbé MR, Dumais L, Chao E, Junkins B. Health claims on foods in Canada. J Nutr. 2008;138:1221S–7S.
23. Jew S, Vanstone CA, Antoine J-M, Jones PJH. Generic and product-specific health claim processes for functional foods across global jurisdictions. J Nutr. 2008;138:1228S–36S.
24. Ames NP, Rhymer CR. Issues surrounding health claims for barley. J Nutr. 2008;138:1237S–43S.
25. Xiao CW. Health effects of soy protein and isoflavones in humans. J Nutr. 2008;138:1244S–9S.
26. Farnworth ER. The evidence to support health claims for probiotics. J Nutr. 2008;138:1250S–4S.
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