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Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: regulatory considerations in Canada, EU, and US

Sanders, M.E., Tompkins, T., Heimbach, J.T. and Kolida, S. (2005) Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: regulatory considerations in Canada, EU, and US. European Journal of Nutrition, 44 (5). pp. 303-310. ISSN 1436-6207

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To link to this article DOI: 10.1007/s00394-004-0527-6

Abstract/Summary

Successful and responsible introduction of probiotic and prebiotic products into the worldwide marketplace requires labelling for health benefits that meets consumer needs, adheres to regulatory standards and does not overextend scientific evidence. Regulations differ among countries, but underlying all is an emphasis on scientific credibility of any statements of health benefits. This paper considers the value of different types of evidence offered in substantiation of efficacy and reviews different regulatory approaches to labelling for health claims. Limitations of in vitro, animal and different types of human studies used for efficacy substantiation for probiotics and prebiotics are discussed.

Item Type:Article
Refereed:Yes
Divisions:Faculty of Life Sciences > School of Chemistry, Food and Pharmacy > Department of Food and Nutritional Sciences
ID Code:13015
Uncontrolled Keywords:probiotics, prebiotics, regulatory, health claims, PLACEBO-CONTROLLED TRIAL, DIARRHEA

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