Evidence for Health Claims on Foods

The Journal of Nutrition Evidence for Health Claims on Food: How Much Is Enough?

Evidence for Health Claims on Foods: How Much is Enough? Introduction and General Remarks1,2 Peter J. H. Jones,3* Nils-Georg Asp,4 and Primal Silva5 3

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, Winnipeg, Manitoba R3T 6C5, Canada; SNF Swedish Nutrition Foundation and Lund University, Lund SE-223 70, Sweden; and 5Research Branch, Agriculture and Agri-Food Canada, Ottawa, Ontario K1A 0C5, Canada 4

Introduction

1 Published in a supplement to The Journal of Nutrition. Presented as part of the Canadian Nutrition Congress held in Winnipeg, Canada, June 18–21, 2007. This conference was supported by Nestle´ Nutrition; Canadian Egg Marketing Agency; Danone Institute; Dow AgroSciences Canada; Flax Canada 2015; Martek Biosciences Corporation; The Centrum Foundation; Canadian Grain Commission; Dairy Farmers of Canada; Faculty of Agricultural and Food Sciences, and Faculty of Human Ecology, University of Manitoba; Manitoba Science, Technology, Energy and Mines; Mead Johnson Nutritionals; The Manitoba Co-operator; Alltech Canada; Agri-Food Research and Development Initiative (ARDI); Beef Information Centre; Canola Council of Canada; Cognis; Elanco Animal Health; Grainews; Lipid Nutrition; Manitoba Agriculture, Food and Rural Initiatives; Maple Leaf Animal Nutrition; Monsanto Canada; Pfizer Animal Health; Prairie Hog Country; Pulse Canada; Bruker Optics; Bunge Canada; Canbra Foods; Faculty of Graduate Studies, University of Manitoba; Novus International; and POS Pilot Plant Corp. This publication was supported by Danone Institute International and Agriculture and Agri-Food Canada. Supplement Coordinators for this publication were Peter Jones, University of Manitoba, Winnipeg, Canada and Primal Silva, Agriculture and Agri-Food Canada, Ottawa, Canada. Supplement Coordinator disclosure: P. Jones received travel support and has a consulting agreement from Danone Institute International; P. Silva is employed by the supplement sponsor, Agriculture and Agri-Food Canada. 2 Author disclosures: P. J. H. Jones is currently under a consulting agreement with the supplement sponsor, Danone Institute International; N-G Asp is employed partly by the Swedish Nutrition Foundation, Danone is one of its member companies. P. Silva is employed by the supplement sponsor, Agriculture and Agri-Food Canada. * To whom correspondence should be addressed. E-mail: peter_jones@ umanitoba.ca.

This process of systematic assessment of scientific evidence linking functional ingredients to health through the use of health claims on foods possesses potential benefits for several stakeholders. First, the individual consumer profits from guidance on which foods and food ingredients possess the potential to reduce risk of degenerative disease, improve longevity, and reduce dependence on pharmaceuticals. Second, health care service providers enjoy reduced operating costs resulting from a healthier population with reduced requirements for drugs. Third, corporations profit from improved market share, subsequent to increased appeal and penetration of products bearing health claims within the food marketplace. Fourth, food producers profit from higher commodity prices obtained from food constituents with added health value. Last, research activity in the agriculture-food-health continuum ensures continued livelihood and activity of scientists and technologists, thus improving food-related bioproducts. As a result, this supplement, which captures the proceedings of a symposium held at the Canadian Nutrition Congress meeting in Winnipeg, Canada, June 21, 2007, endeavors to achieve 2 objectives. In the first part, Global Assessment of Health Claims Frameworks, a cross-jurisdictional review is undertaken, profiling the history and current state of the art regarding legislative and scientific processes for establishment of health claims on foods. The second part, Evidence-Based Review of Health Claims on Bioactives in Foods, gives examples of how specific functional ingredients have dealt with complex science issues that need to be addressed for the establishment of health claims. Part I: Global Assessment of Health Claims Frameworks This part deals with a range of examples across jurisdictions spanning from Japan, where health claim legislation is very well advanced, to countries such as Canada, which has demonstrated a much more conservative health claims legislative environment over recent decades. The first article by Yamada et al. (1) in this section focuses on how the Japanese Foods for Specified Health Use system for establishing health claims was created and what criteria are required for the over 700 approved products within that country. The categories of existing health claims in Japan are also provided, as is information concerning the new federal safety effec-

0022-3166/08 $8.00 ª 2008 American Society for Nutrition. J. Nutr. 138: 1189S–1191S, 2008.

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Through advances in clinical trial design, analytical methodologies for assessing the nature and level of the bioactive constituents, and establishment of processes for systematic assessment of available literature, health claims on foods are becoming increasingly recognized as important and consequently are being legally regulated in more and more countries around the world. Legislation pioneered largely in Japan began to emerge in the 1980s to bring some systematization to the issue of how much data are required to substantiate a claim for a given dietary agent in order to improve a function and/or modify physiological processes in a manner consistent with the attenuation of disease risk. Various jurisdictions around the globe have now developed series of systematic approaches for reviewing scientific data and ascribing linkages between dietary ingredients and disease risk reduction, as well as performance and well-being, with the common objectives of identifying the threshold of scientific evidence needed to substantiate an authoritative statement to the general public in the form of a label claim for a given marketed food product.

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Supplement

that of the U.S. Nutrition Labeling and Education Act and authoritative statements under the U.S. Food and Drug Administration Modernization Act. The close overlap in the Canadian regulatory system between definitions of drugs and foods is identified as a challenge within the existing health claim policy structure. Thus, the first part of this supplement provides a synopsis of current models, from Japan, China, Australia-New Zealand, the European Union, and North America for establishing health claims and the underlying principles used in each domain. Comparison among these models underscores the pronounced heterogeneity in the relative permissiveness of claims across these various jurisdictions. Part II: Evidence-Based Review of Health Claims on Bioactives in Foods The second part of this supplement presents examples of how specific functional ingredients are dealt with under the more general global rubric of health claim legislation. Using specific case examples, the authors of these articles examine the complex science issues that need to be addressed for the establishment of health claims. Various categories of bioactive nutrient components are discussed as examples of the types and levels of evidence that are perceived by regulatory authorities as necessary to support a permissible health claim. Jew et al. (7) set out to investigate the type and amount of evidence needed across various jurisdictions worldwide to substantiate both generic and product-specific health claims. In organizing this section, 2 functional ingredients were selected as case studies. First, (n-3) fatty acids were considered as a scenario where evidence for efficacy can be considered to be substantial. Second, probiotics were considered as a scenario where evidence for biological efficacy is deemed less consistent, and biomarkers of physiological effectiveness have been less well defined. Although all jurisdictions were found to rely on double-blinded, controlled human trials, a high degree of discordance was noted regarding how different jurisdictions first select and then evaluate the quality of studies used to substantiate each claim. Additional examples using other case studies of barley, soy, and probiotics authored by Ames and Rhymer (8), Xiao (9), and Farnworth (10), respectively, are provided in subsequent articles in this section of the supplement. These articles critically review scientific evidence that supports health claims applicable to each product category and outline areas where scientific evidence is lacking. In addition, these authors highlight practical issues such as differences in food-processing methods that can affect the overall results as well as potential benefits to consumers. Scientific and Policy Considerations Although the various articles highlight the wide-ranging distinctions in approach, categorization, and permissiveness of health claims among countries, certain consistent elements emerge from the synthesis of the different systems across the world. Across regulatory environments, there are invariably set requirements for scientific substantiation of claims, usually in the form of well-designed human intervention trials, although the type and amount of scientific evidence required are demonstrated to be quite variable. Most clinical trials are derived from the published literature, where the onus is on the peer-review system to ensure that an appropriate standard of rigor is applied in the assessment of the quality of these intervention trials through that peer review process. Heightened scrutiny of clinical trial design and data before publication will improve overall credibility within the nutrition arena, and particularly in the


tiveness information network, which serves as a source of data for the general population. The second article by Yang (2) examines health claim legislation in China. Issues surrounding the evolution of current regulations and the degree of scientific substantiation that serves as a basis for establishing a health claim are articulated in this article. Yang explores China’s rich history of traditional medicine, which now serves as a platform for the scientific substantiation of functional food health claims. Emphasis is placed on the nature of evidence required and on the process of application to secure a health claim in any of the 27 categories of claims allowed within the scope of the over 7400 products now legally able to carry label claims in China. The third article in this section, by Tapsell (3), examines the processes that have shaped health claim legislation in Australia and New Zealand, governed collectively by Food Standards Australia New Zealand. This article critically describes the existing regulatory framework, examines issues related to substantiation of claims, and provides commentary on the proposed assessment of evidence for legislation soon to be enacted in that region. In particular, the article discusses the amount of evidence needed to establish a causal relation between a food and a measurable health outcome in the intended population and within an achievable whole-diet context. The fourth article by Asp and Bryngelsson (4) examines the emerging system for health claims regulation within the 27 member states of the European Union, effective from 2007. The evolution of the Process for the Assessment of Scientific Support for Claims on Foods project and its generally applicable criteria for scientific substantiation of claims are described. Discussion of legislation and scientific substantiation of both generic claims, closely related to official nutrition recommendations, and product-specific claims, based on human intervention studies with the product, is provided within this article. Specific examples are presented about experience within codes of practice applied in Sweden, The Netherlands, and the United Kingdom before the European Union regulation. The article also focuses on important issues of development of valid scientific study designs, identification and validation and use of appropriate biomarkers to explore the effects of diet on health within the context of the Process for the Assessment of Scientific Support for Claims on Foods project. The fifth and sixth (5,6) articles in this section address health claims in North America. The current categories of claims used on food and dietary supplement labels in the United States are reviewed by Hasler (5), with a description of the history of the evolution of each of these categories. Highlighted in this article is the importance of the role of industry in spearheading the establishment of health claims. Moreover, this article extends the previous discussion by signaling the potential confusion that an overly complicated health claim system can render on the part of consumers, particularly in the context of the complex wording of the category of claims identified as qualified health claims. Concerns are discussed that consumers in the United States appear to rely less on health and nutrition information on package labels than previously when they make purchase decisions. Finally, L’Abbe´ et al. (6) discuss health claims on foods in Canada. Regulations governing the different health claims appearing on packaging or in advertising for foods sold in Canada are described, including the various categories of health claims, their mechanisms for review and approval in Canada, the standards of evidence needed to support such claims, and the criteria required for foods to carry claims. This article reviews the integration of the Canadian health claim framework with

tion behavior among certain consumers who overreact to a health claim message. In general, nutrition profiles can be discussed in terms of ‘‘nutritional safety,’’ meaning that ‘‘functional foods’’ must not counteract principles for a generally balanced and healthy diet. Finally, it should be pointed out that some of the current issues and uncertainties regarding the validity and benefits of health claims are likely to find resolution in the future with access to superior technologies. Advances in the fields of nutrigenomics and metabolomics with the inherent capacity to enhance our understanding of the interaction between nutrition and genes, utilization of nutrients by the body at the molecular level, and influence on overall function will significantly improve our understanding of diet-health relations. These advances will create the possibility of not only identifying the precise nutritional needs of individuals and groups with similar genetic and metabolic characteristics but also yield a way of meeting those requirements in a precise manner using foods of defined nutrient characteristics. Such knowledge can lead to innovative approaches in dealing with diet-related diseases including diabetes, cardiovascular disease, and cancer. Because of the economic importance of this area, with current global sales in nutritional products estimated to be ;$200 billion USD and the potential to exponentially increase markets, there will be a strong interest from both industry and governments to capitalize on these opportunities. Equally, consumers will benefit from improved access to food products with health benefits and the availability of authoritative scientific information permitting them to make informed choices. In summary, the present blend of contributions within this supplement provides for the first time a global perspective on the current state of knowledge concerning the fast-emerging topic of health claims on foods. Through the process of examination of the existing legislative models globally, it is hoped that eventually a common format can be adopted that will serve as middle ground for emerging jurisdictions looking to set standards of evidence for food health claim policy development.

Literature Cited 1.

Yamada K, Sato-Mito N, Nagata J, Umegaki K. Health claim evidence requirements in Japan. J Nutr. 2008;138:1192S–8S. 2. Yang Y. Scientific substantiation of functional food health claims in China. J Nutr. 2008;138:1199S–205S. 3. Tapsell LC. Evidence for health claims: A perspective from the Australia–New Zealand region. J Nutr. 2008;138:1206S–9S. 4. Asp N-G, Bryngelsson S. Health claims in Europe: New legislation and PASSCLAIM for substantiation. J Nutr. 2008;138:1210S–5S. 5. Hasler CM. Health claims in the United States: An aid to the public or a source of confusion? J Nutr. 2008;138:1216S–20S. 6. L’Abbe´ MR, Dumais L, Chao E, Junkins B. Health claims on foods in Canada. J Nutr. 2008;138:1221S–7S. 7. Jew S, Vanstone CA, Antoine J-M, Jones PJH. Generic and productspecific health claim processes for functional foods across global jurisdictions. J Nutr. 2008;138:1228S–36S. 8. Ames NP, Rhymer CR. Issues surrounding health claims for barley. J Nutr. 2008;138:1237S–43S. 9. Xiao CW. Health effects of soy protein and isoflavones in humans. J Nutr. 2008;138:1244S–9S. 10. Farnworth ER. The evidence to support health claims for probiotics. J Nutr. 2008;138:1250S–4S.

Introduction and general remarks

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context of the reliability of use of these data to establish and sustain food-related health claims. A notable feature of the contributions to this supplement is the speed of change in the current health claims regulatory framework on a global scale. Several jurisdictions including the European Union, Australia, New Zealand, China, and Canada are poised at the threshold of invoking major advances in health claim policy. In each region, specific criteria for the scientific substantiation of claims have been established in the context of local regulations and scientific information. It is likely that additional countries will move toward inception of health claim policies in the near future, given the continuing interest in nutrition in the context of preventative health. Anyone looking to this supplement for guidance in establishing a policy framework for health claims within new jurisdictions may come away with the impression that so much variability exists across countries and claim categories as to make it difficult to find internal consistency. It is, however, important to recognize that there is ongoing United Nations-led Codex work on this issue, which will be important in future harmonization of the requirements for scientific substantiation of claims around the world. In the future it can be expected that a heightened degree of convergence of health claim policy development will occur as these issues are more broadly discussed. The importance of health claims depends on consumers’ understanding and confidence. Regulators, industry, and the scientific community need to come together to find reasonable compromises between simplicity/understandability for consumers and scientific rigor to ensure that any food-borne health claim corresponds to its scientific background. As raised within the article describing health claims in the United States (5), overly complex messages within a very complicated regulatory structure will forseeably lead to disenfranchisement from the very community that the initiative is designed to serve. Health claim messages must be kept straightforward and simple to sustain consumer confidence. Foods with health claims, functional foods, should always be placed within the context of a healthy diet and nutritional eating practices. Supplementing one’s diet with functional foods should not be perceived as correcting an otherwise unhealthy diet. There are more or less pronounced requirements for communicating this issue across the different regulations covered in this supplement. As is evidenced in the various articles, some jurisdictions have or are introducing requirements for certain nutrition profiles to be met for foods with both nutrition and health claims. Additionally, foods with health claims need to be efficacious in terms of performance, well-being, or disease risk reduction; however, these foods need also to be safe for consumption at higher levels of intake. Health claims by their very nature can promote overconsumption of the foods on which they are affixed; some consumers regard these health claims as an invitation to ingest excessive amounts of such foods. Regarding safety issues, the general principle that foods must be safe of course applies to foods with health claims. Thus, assurances must be made within existing legislative frameworks that this issue has been given broad consideration. Jurisdictions that are more conservative in permitting health claims may be doing so to ensure public safety given the propensity of higher consump-