PASSCLAIM - Synthesis and review of existing processes

Abstract

Several approaches to the use of health claims on foods have been made around the world, and the common theme is that any health claim will require scientific validation and substantiation. There is also broad consensus that any regulatory framework should protect the consumer, promote fair trade and encourage innovation in the food industry.This paper is based on a critical evaluation of existing international approaches to the scientific substantiation of health claims, with a view to identifying common new ideas, definitions, best practice and a methodology to underpin current and future developments. There is a clear need to have uniform understanding, terminology and description of types of nutrition and health claims. Two broad categories were defined: Nutrition Claims, i. e. what the product contains, and Health Claims, i. e. relating to health, well-being and/or performance, including well-established nutrient function claims, enhanced function claims and disease risk reduction claims. Such health claims relate to what the food or food components does or do. The categories of health claims are closely and progressively related and are, in practice, part of a continuum. Provision is also made for "generic" or well-established, generally accepted claims and for "innovative" or "product-specific" claims. Special attention was paid to reflect the health-promoting properties of a food or food component in such a way as to facilitate the making of risk reduction claims outside the medical scope of the term prevention. The paper sets out basic principles and guidelines for communication of health claims and principles of nutritional safety. The main body of the work examines the process for the assessment of scientific support for health claims on food and emphasises an evidence-based approach consisting of: Identification of all relevant studies exploring the collection of evidence, data searches, the nature of the scientific evidence, sources of scientific data (including human intervention studies, human observational studies, animal studies and in vitro studies, and the use of biomarkers in human studies. Evaluation of the quality of individual studies to ensure good experimental design and interpretation. Interpretation of the totality of evidence to apply scientific judgement to interpret the weight of evidence as a whole. Assessment of significant scientific agreement on a case-by-case basis to agree within the relevant scientific community that an association between a food or a food component and a health benefit is valid. Annexes include an international comparison of regulatory approaches to health claims, suggestions for the documentation and presentation of evidence, and a procedure for reviewing the evidence.

Nutrition communication: consumer perceptions and predicting intentions

“…'low in fat', 'high in fibre' or 'no added sugar'. Thus, it can be a content claim that describes the level of nutrient contained in the food or a comparative claim, where it compares the nutrient levels and/or energy value of two or more foods (8) . In contrast, health claims propose that if you eat a particular product it will improve a specific physiological function or reduce the risk of a certain disease.…”

A standardised approach towards PROving the efficacy of foods and food constituents for health CLAIMs (PROCLAIM): providing guidance

“…Graphical representation for weighing of the evidence on a case-by-case basis in support of a health claim. †Adapted from Richardson et al (33) . The arrows reflect the fact that the totality of the evidence is made up of different sources of scientific data, and that each health relationship and claim must be assessed on a case-by-case basis to reflect the strength, consistency and coherence of the information.…”

Preparing dossiers: strength of the evidence and problems of proof

“…lowered LDL cholesterol for CHD. Clearly, the relationship between dietary components and health benefits can be demonstrated by a number of different types of studies and designs, and methodological soundness overrides any hierarchy in study type, but also on the quality of its design, execution and analysis (10,34) . All sources of scientific data have inherent limitations and strengths, and hence a critical review of the totality of the available data and weighing of the evidence should form the basis of the substantiation of a health claim on a case by case basis.…”

“…These concerted action projects were funded by the EC, managed by the International Life Sciences Institute Europe, and their objectives were to expedite and underpin the development of a harmonised EU regulatory process on health claims. A review of the processes and methodologies for the scientific substantiation of health claims around the world was set out under PASSCLAIM by Richardson et al (10) . The main objective of this paper was to identify common new ideas, definitions and best practice globally.…”