Document Detail

Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: regulatory considerations in Canada, E.U., and U.S.
MedLine Citation:
PMID:  15338247     Owner:  NLM     Status:  MEDLINE    
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.
M E Sanders; T Tompkins; J T Heimbach; S Kolida
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Publication Detail:
Type:  Journal Article     Date:  2004-09-02
Journal Detail:
Title:  European journal of nutrition     Volume:  44     ISSN:  1436-6207     ISO Abbreviation:  Eur J Nutr     Publication Date:  2005 Aug 
Date Detail:
Created Date:  2005-07-25     Completed Date:  2006-01-17     Revised Date:  2006-04-13    
Medline Journal Info:
Nlm Unique ID:  100888704     Medline TA:  Eur J Nutr     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  303-10     Citation Subset:  IM    
Dairy and Food Culture Technologies, 7119 S. Glencoe Ct., Centennial (CO) 80122, USA.
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MeSH Terms
Consumer Product Safety
Dietary Supplements
European Union
Evidence-Based Medicine*
Food Labeling / legislation & jurisprudence*
Food Microbiology
Health Food / standards*
Health Promotion
Legislation, Food*
Models, Animal
United States

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