title: Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: regulatory considerations in Canada, E.U., and U.S.
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.
authors.affiliation: Dairy and Food Culture Technologies, 7119 S. Glencoe Ct., Centennial (CO) 80122, USA. mes@mesanders.com
authors.forename: M E
authors.initials: ME
authors.lastname: Sanders
authors.forename: T
authors.initials: T
authors.lastname: Tompkins
authors.forename: J T
authors.initials: JT
authors.lastname: Heimbach
authors.forename: S
authors.initials: S
authors.lastname: Kolida
mesh_terms: D000818:Animals; D002170:Canada; D003257:Consumer Product Safety; D019587:Dietary Supplements; D005062:European Union; D019317:Evidence-Based Medicine; D005515:Food Labeling / Q000331:legislation & jurisprudence*; D005516:Food Microbiology; D058870:Food, Organic / Q000592:standards*; D006293:Health Promotion; D006801:Humans; D007881:Legislation, Food; D023421:Models, Animal; D019936:Probiotics; D014481:United States