Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: regulatory considerations in Canada, E.U., and U.S

European Journal of Nutrition
Mary Ellen SandersS Kolida

Abstract

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.

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Citations

Sep 18, 2012·Advances in Nutrition·Sharon M DonovanMary Ellen Sanders
Oct 13, 2009·The Journal of Allergy and Clinical Immunology·Jeroen HolEdward E Nieuwenhuis
Mar 2, 2006·Risk Analysis : an Official Publication of the Society for Risk Analysis·Douglas L Weed
Mar 3, 2006·Current Opinion in Biotechnology·Maria L MarcoMichiel Kleerebezem
Jul 11, 2006·Advances in Applied Microbiology·S KolidaG R Gibson
Oct 20, 2018·Journal of Food Science·Cristina González-DíazCarlos Álvarez-Dardet
Nov 26, 2009·European Journal of Nutrition·Rolf Grossklaus
Jul 30, 2008·Expert Review of Anti-infective Therapy·Giovanna BlandinoRoberto Di Marco
Jun 21, 2013·Journal of Chemotherapy·Marco ToscanoLorenzo Drago
Jan 4, 2018·Journal of Interpersonal Violence·Kyoung Min ShinHyoung Yoon Chang
May 22, 2008·The Journal of Nutrition·Edward R Farnworth
Jul 21, 2017·Journal of Agricultural and Food Chemistry·Lin TaoYu Zong Chen
Jan 12, 2010·International Journal of Food Microbiology·Paolo AureliGiovanna Franciosa

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