Scientific Opinion on the substantiation of a health claim related to proanthocyanidins in Urell® and reduction of bacterial colonisation of the urinary tract by inhibition of the adhesion of P-fimbriated E. coli to uroepithelial cells pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2013;11(7):3326 [10 pp.].
doi
10.2903/j.efsa.2013.3326
Panel members at the time of adoption
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Hildegard Przyrembel, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren, Hans Verhagen and Peter Willatts for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of France following an application by Pharmatoka
Question Number
EFSA-Q-2012-00700
Adopted
10 July 2013
Published
26 July 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following an application from Pharmatoka, submitted pursuant to Article 13.5 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a Urell® product containing cranberry (Vaccinium macrocarpon) juice powder standardised for proanthocyanidins (PAC) content and bacterial colonisation of the urinary tract by inhibition of the adhesion of P-fimbriated E. coli to uroepithelial cells. The food that is the subject of the health claim is PAC in Urell®. The Panel considers that the food constituent, PAC in Urell®, which is the subject of the claim, is sufficiently characterised. The Panel considers that reduction of bacterial colonisation of the urinary tract by inhibition of the adhesion of P-fimbriated E. coli to uroepithelial cells is a beneficial physiological effect. No human studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the consumption of proanthocyanidins in Urell® and reduction of bacterial colonisation of the urinary tract by inhibition of the adhesion of P-fimbriated E. coli to uroepithelial cells.

Summary

Following an application from Pharmatoka, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to proanthocyanidins in cranberry and reduction of bacterial colonisation of the urinary tract by inhibition of the adhesion of P-fimbriated E.coli to uroepithelial cells.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The application includes a request for the protection of proprietary data.

The food that is the subject of the health claim is Urell®, a food supplement containing cranberry (Vaccinium macrocarpon) juice powder standardised for its content in proanthocyanidins (PAC). The food constituent which is responsible for the claimed effect is PAC in Urell®. The Panel considers that the food constituent, PAC in Urell®, which is the subject of the health claim, is sufficiently characterised.

Upon a request by EFSA, the applicant clarified that the claimed effect is “reduction of the bacterial colonisation of the urinary tract”, and that “inhibition of the adhesion of P-fimbriated E. coli to uroepithelial cells” is the mechanism by which the claimed effect is achieved. The target population proposed by the applicant is the general population. The Panel considers that reduction of bacterial colonisation of the urinary tract by inhibition of the adhesion of P-fimbriated E. coli to uroepithelial cells is a beneficial physiological effect.

The applicant identified one human intervention study which investigated the effect of Urell® (36mg PAC/capsule) on bacteriuria in vivo (Bianco et al., 2012, a letter to the editor) as being pertinent to the claim. The Panel considers that owing to major methodological limitations (i.e. inappropriate urine sampling methods, inappropriate handling of mixed microbial positive cultures, and insufficient reporting of the methods used for the identification of pathogenic bacteria), no conclusions can be drawn from this study for the scientific substantiation of the claim.

The applicant also provided one intervention study (Botto and Neuzillet, 2010) on the effects of Urell® in subjects with asymptomatic bacteriuria after radical cystectomy and ileal cystoplasty as supportive evidence for the claim. The Panel agrees with the applicant that the results obtained in patients with radical cystectomy and ileal cystoplasty cannot be extrapolated to the target population (i.e. general population) for this claim.

In addition, the applicant provided two studies on the ex vivo anti-adherence properties of urine from subjects consuming Urell® (Lavigne et al., 2008; Howell et al., 2010) as being pertinent to the claim. The Panel considers that these studies do not provide evidence that aninhibition of the adhesion of P-fimbriated E. coli to uroepithelial cells in urine from subjects consuming PAC in Urell® is predictive of the occurrence of a clinically relevant inhibition of the adhesion of P-fimbriated  E. coli to uroepithelial cells in humans in vivo.

The Panel notes that no human studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of proanthocyanidins in Urell® and reduction of bacterial colonisation of the urinary tract by inhibition of the adhesion of P-fimbriated E. coli to uroepithelial cells.

Keywords
Proanthocyanidins, cranberry, Vaccinium macrocarpon, Urell®, urinary tract, health claims
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Number of Pages
10