Substantiation of Health Claims on Foods – a European Perspective

D P Richardson DPR Nutrition Ltd, Croydon, UK

INTRODUCTION TO THE EUROPEAN REGULATORY FRAMEWORK

Consumers should be able to make choices based on clear and accurate information and an important objective for the development of European legislation is to ensure that claims on foods can be properly justified and scientifically substantiated¹. A final proposal for Regulations of the European Parliament and of the Council on nutrition and health claims made on foods is expected to permit the use of “health claims” and “reduction of disease risk claims” on foods outside the scope of medicinal law, and Article 6 sets out the general principles to substantiation (Table 1)². Health claims will, therefore, only be approved for use on the labelling, presentation and advertising of foods in the community market after a scientific evaluation of the highest possible standard. Currently, the proposed legislation states that, in order to ensure harmonised scientific assessment of a health claim, the European Food Safety Authority (EFSA) should carry out the assessments. It is anticipated that for long-established and non-controversial science e.g. for health claims that describe the role of a nutrient or other substance in growth, development and normal physiological functions of the body, the assessment and approval prior to their use, will result in the compilation and adoption of an approved list within a 3 year period and that the EU will develop a “Register” of health claims. For all other health claims, an authorization procedure will be developed based on substantiation by generally accepted scientific data.

EUROPEAN COMMISSION CONCERTED ACTION PROJECTS

In April 2001, the International Life Sciences Institute (ILSI Europe) initiated the Concerted Action (CA), supported by the European Commission on a “Process for the Assessment of Scientific Support for Claims on Foods (PASSCLAIM)”³. The PASSCLAIM built on the CA on Functional Food Science in Europe (FUFOSE), which suggested that claims for “enhanced function” and “reduced risk of disease” should be based on sound scientific evidence, using appropriate validated biomarkers⁴. The FUFOSE consensus documents were published in the British Journal of Nutrition⁵. The objectives and applications of PASSCLAIM are shown in Table 2.

Phase I of PASSCLAIM focused on three physiological areas or Individual Theme Groups (ITGs), namely diet-related cardiovascular disease (ITGA), bone health and osteoporosis (ITGB) and physical performance and fitness (ITGC). In each of these areas the current use of markers and the evidence base to support claims were critically assessed. In addition, a fourth group (ITGD) reviewed the current global situation in terms of existing laws, codes of practice and other schemes which were used to regulate health claims. These ITGA to ITGD papers were published in the European Journal of Nutrition in March 2003⁶. In a second phase of PASSCLAIM, four other ITGs are addressing the areas of insulin sensitivity and risk of diabetes (ITGE), diet-related cancer (ITGF), mental state and performance (ITGG) and gut health and immunity (ITGH). Based on this experience, it is anticipated that the process and the criteria for scientific support for health-related claims on foods and food components will help underpin the evolving European harmonised regulatory framework.

GUIDELINES AND CODES OF PRACTICE ON HEALTH CLAIMS IN THE EU

Several European countries have already developed guidelines and codes of practice on what to do with health claims and they evolved in the absence of an EU regulatory framework. They all, however, established a broad consensus that any new legislation should protect consumers from false and misleading claims, promote fair trade and encourage innovation in the food industry.

Although nutritional and medical sciences recognise the contribution that diet and individual foods or food components may make the reduction of risk of disease, current EU law prevents the communications of those benefits to consumers, whereas the law on medicinal products is established on a very broad basis that includes foods making preventative, therapeutic or curative claims. The new EU regulatory proposals², however, will reflect the ‘health-promoting’ properties of foods and food components in such a way as to facilitate such claims for risk reduction to be made outside the medical scope of the term “prevention.” This new concept of health claims reflects the fact that foods with health claims are primarily aimed at either the healthy population or healthy individuals, recognises that the disease is not present, the cause of chronic disease tends to be multifactorial, including dietary, behavioural, environmental and genetic factors. It also recognises that the modification of certain dietary components alone cannot ensure that a disease will not develop, since it does not affect the other confounding factors. Nevertheless the food(s) or food component(s) may help substantially to reduce the likelihood of getting the disease.

The new EU draft proposals on nutrition and health claims will hopefully overcome the potential for divergent and inconsistent interpretations and enforcement of existing European local regulation, guidelines and codes.

SYNTHESIS AND REVIEW OF THE PROCESSES FOR SCIENTIFIC SUBSTANTIATION OF HEALTH CLAIMS

The objective of PASSCLAIM ITGD was to identify common new ideas, definitions, best practice and a methodology to underpin current and future regulatory developments⁷. The PASSCLAIM initiative, and now the proposed draft regulations, have defined two broad categories of claim: “Nutrition Claims,” based on what the product contains and “Health Claims” relating to health, well-being and/or performance, including well-established nutrient function claims, enhanced function claims and disease risk reduction claims. These health claims relate to what the foods or food components do. When a health claim is used the criteria set out in Table 3 must be demonstrated, if appropriate. Depending on the nature of the health claim, the following data should be considered for scientific substantiation, where applicable:

IDENTIFICATION OF ALL RELEVANT STUDIES

A health claim should be based on a systematic and objective compilation of all the available scientific evidence. The compilation has to be done in a balanced and unbiased way to ensure that all relevant data, both positive and negative has been included in the documentation. The evidence is likely to come from:-

• Human intervention studies such as well-designed, randomised controlled trials (RCTs) that provide the most persuasive evidence of efficacy in human subjects. Double blinding, where practicable, will also reduce bias if the researcher who assesses the outcome does not know which subjects received the intervention. RCTs of dietary change through to a disease outcome are uncommon and are most likely to involve addition or subtraction of a single component or nutrient. Most health claims allowed by the US Food and Drug Administration have not been supported by RCTs. There are, however, hundreds of controlled trials of dietary change with a surrogate outcome - risk factors such as plasma total cholesterol or LDL cholesterol, plasma glucose or blood pressure. Meta-analysis of collections of such trials can be useful, if properly undertaken and interpreted, to establish scientific linkages between diet and disease. For example, saturated fat has been shown to increase plasma total cholesterol and many cohort studies have found that plasma total cholesterol is a biomarker for coronary heart disease (CHD). Hence, saturated fat increases the risk of CHD. The use of validated and predictive biomarkers is essential for the substantiation of health claims. Their use, however, must take into account intra-individual variation, the use of single measurements, timings of measurements and the progression of disease. Within a study, the biomarker should change in a biologically relevant way and the change should be statistically significant for the target group⁸.
• Human observational studies. In these studies, the investigator has no control over the exposure or the intervention. In general, observational studies include - in descending order of persuasiveness - cohort (longitudinal) studies, case-control studies, cross-sectional studies, uncontrolled case series or cohort studies, time-series studies, descriptive epidemiology and case reports. Observational studies may be prospective or retrospective. Although observational studies have their limitations in that they do not provide direct evidence of cause and effect, cohort prospective studies stand out for their driving role in building present concepts of diet and disease9. The recently approved health claim both in Sweden¹⁰ and the UK Joint Health Claims Initiative (JHCI)¹¹ that wholegrain cereal foods are associated with a healthy heart are based on the accumulation of epidemiological evidence between 1996 and 2001. These very large cohort studies in the USA, Finland and Norway show a consistent protective effect of wholegrains and reduced risk of CHD and that an intake of three servings per day may have an important cardio-protective effect¹².
• Animal studies and in vitro studies. These studies can provide useful information on the mechanisms of action, dose-response relationships and on the metabolic processes that cause disease or a health benefit. When strictly controlled these kinds of studies permit greater control over confounding variables, including diet and genetics, as well as more aggressive interventions. Ultimately, all these studies suffer from the uncertainties of extrapolating results to physiological effects in humans.

THE EVALUATION OF THE QUALITY OF INDIVIDUAL STUDIES

The data searches depend on a carefully considered and clearly defined health benefit, clear search terms and defined key words as well as explicit and predefined inclusion and exclusion criteria. The reasons used for rejection of papers as flawed must be clear and unambiguous, and the methodological quality of the included studies must be high. The individual studies must be evaluated for rigour of design, appropriateness of methods, controls and procedures, adequacy of the description of the study population, reliability of measures of intake of a particular diet, food or food component and health outcomes, sufficiency of statistical power, the interpretation and strength of the conclusions and the comprehensiveness of reporting⁷.

TOTALITY OF EVIDENCE

Once the relevant, good quality papers have been identified and their strengths and weaknesses assessed, the totality or weight of evidence as a whole needs to be assessed. Factors to be considered include the consistency of results across different studies and study designs, consistency among various populations and within them, the magnitude of the effect, strength of association, dose-response relationships, temporal relationships, biological plausibility, specificity of effect and statistical validity.

The overall assessment needs the application of scientific judgment and critical interpretation of the data as a whole. The final assessment involves judging that the evidence in support outweighs the evidence against i.e. the balance of probabilities is such that the change in the dietary intake of the food or food component will result in the physiological benefit and/or health outcome, including a change in disease endpoint.

ASSESSMENT OF SIGNIFICANT SCIENTIFIC AGREEMENT

In order for qualified experts to reach an informed opinion regarding a particular claim, the data and information needs to be presented in a systematic way so that the dossier can be “navigated” and assessed efficiently. The UK JHCI has prepared “Guidelines for Preparing Dossiers to Substantiate Health Claims”`. As well as requiring a systematic review of the evidence, it requires supplementary information about current intakes, expected impact on the overall diet, recommended consumption patterns, examples of products likely to carry the claim, examples of wordings of the claim that may be used as well as demonstration of overall compliance with the legal, nutrition and consumer principles set out in the JHCI Code of Practice¹⁴.

The interplay of considerations influences the extent of agreement among qualified experts and how the various types and amount of data for a food or food component and a health benefit can be combined to assess the overall strength and consistency of the scientific evidence. The evidence-based review should use scientific principles, be comprehensive, unbiased, pragmatic and authoritative. Following the scientific assessments, the information can be used in the relevant regulatory, legal and social contexts.

CONCLUSION

The process of substantiation of a health claim will

• benefit consumers by providing information on healthful eating patterns that may help reduce the risk of diseases such as cardiovascular disease, some cancers and osteoporosis,
• provide consumers and healthcare professionals with a reference point and a measure of confidence that claims are supported by sound scientific data,
• provide the claimant with a return on their research investment as well as a measure of insurance when dealing with regulatory authorities,
• stimulate new research to fill in the knowledge gaps revealed during the course of the scientific reviewers.

One of the most important questions to consider is how the health benefits can be communicated effectively to consumers. To ensure the consumers right to reliable information, the processes for the verification of health claims and the wording of the claims for consumer understanding are critical issues of importance for regulators, the food industry, the advertising industry, nutritionists and consumer representatives.

REFERENCES

1. Byrne, D. Health, nutrition and labeling. Food Science and Technology 2003, 17; 26-28.
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3. International Life Sciences Institute (ILSI) Europe. A European Commission Concerted Action Programme supported by the European Commission DG Research, Thematic Programme 1 Quality of Life and Management of Living Resources, Key Action 1 – Health, Food and Nutrition ILSI Europe, 83 Avenue E Mournier, Box 6, B-1200 Brussels 2001.
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10. Swedish Code on Health Claims on Food Products, www.snf.ideon.se 2003
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12. Richardson, DP: Wholegrain health claims in Europe. Proceedings of the Nutrition Society 2003, 62; 161-169.
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14. Joint Health Claims Initiative. Code of Practice on Health Claims on Food. www.jhci.co.uk 2000.
15. Cummings, JH, Pannemans, D and Persin, C. PASSCLAIM. Report of the First Plenary Meeting including a set of interim criteria to scientifically substantiate claims on foods. European Journal of Nutrition 2003, 42; (1) 112-119.

BIOGRAPHY

David Richardson has created a specialist consultancy in nutrition and food science, DPR Nutrition Limited. Formerly Group Chief Scientist at Nestlé UK Ltd, he is now working with a number of clients in the food and pharmaceutical industries. He holds Visiting Professorships at the Universities of Greenwich, Newcastle upon Tyne and Reading. Professor Richardson was an observer on the UK Food Standards Agency Expert Group on Vitamins and Minerals. He is also Chairman of the Individual Theme Group reviewing the process for the scientific substantiation of health claims on foods, as part of the EC Concerted Action Programme (PASSCLAIM) organised by ILSI Europe. He is a Fellow of the Institute of Food Science and Technology and the Royal Society of Medicine.