Healthy Skepticism Library item: 11861

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Aggett PJ.
Criteria for substantiating claims.
Novartis Found Symp 2007; 282:46-53;:
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17913223

Abstract:

Claims are used to support public health advocacy and marketing. Their evidence base is variable. Claims are made on (i) nutrient content, (ii) comparative merits, (iii) health benefits, and (iv) medical benefits. Experience with therapeutic agents has aided the development of recommendations for the substantiation of health claims for foods and food components, with which dietary supplements would be included. An EU Concerted Activity, Functional Food Science in Europe, suggested that such claims should be based on the general outcomes of ‘enhanced function’ and ‘reduced risk of disease’. A further EU Concerted Activity, The Process for the Assessment of Scientific Support for Claims on Foods, proposed that the evidence base should provide: a characterization of the food or food component to which the claimed effect is attributed; human data, primarily from intervention studies that represent the target populations for the claim; a dose-response relationship: evidence of allowing for confounders including lifestyle, consumption patterns, background diet and food matrix; an appropriate duration for the study; a measure of compliance; and have adequate statistical power to test the hypothesis. When ideal endpoints are not easily accessible for measurement, validated and quality assured markers of the intermediate or final outcomes could be used, as long as their relationship is well characterized. Overall, the totality and coherence of published and unpublished evidence should be considered. Assessments for substantiation need expert judgement, weighting of the strength of the claim, and intelligent use of the criteria applied on an individual basis with respect both to gaps in knowledge and to any need for new knowledge and data.

Keywords:
Publication Types: Review MeSH Terms: Dietary Supplements/adverse effects Dietary Supplements/standards* Drug Labeling Evidence-Based Medicine* Food Labeling Health Food/adverse effects Health Food/standards* Humans Legislation, Drug* Legislation, Food* Public Health United States