EFSA health claim opinion

French cranberry claim winner says EFSA failed to evaluate submitted claim wording

By Shane Starling

- Last updated on GMT

Related tags: Urinary tract infection

Bogged: Cranberry health claims in the EU
Bogged: Cranberry health claims in the EU
French cranberry firm Pharmatoka says the European Food Safety Authority (EFSA) failed to assess its submitted urinary tract infection (UTI) health claim wording, which was the very same as that approved by the French Food Agency (ANSES) in 2004.

Owner Gunter Haesaerts said he was disappointed in the EFSA verdict, and the fact the article 13 general function section of the nutrition and health claims regulation (NHCR) stipulated data could not be added to the initial dossier.

“We are extremely disappointed with this global negative opinion because our cranberry proanthocyanidins (PACs) based food supplement is sufficiently characterised and the evidence we supplied was adequate in relation to the requested claim wording,”​ Haesaerts said.

“We regret that EFSA did not evaluate the specific wording of our claim, which was the same as the validated ANSES claim. We equally regret that the 13.1 procedure did not allow us to add substantial new clinical and mechanistic data that became available between 2008 when we submitted the petition and 2011.”

The French claim states cranberries​ with 36 milligrams of PAC​s can,“help reduce the adhesion of certain E. coli bacteria to the urinary tract walls”.

Specificity

Haesaerts said the wording generated by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) was too general.

“We know for a fact from the large amount of evidence including in vitro, ex vivo and in vivo clinical trials over the past 18 years , that the bacterial anti-adhesion activity caused by cranberry proanthocyanidins(PAC) and their metabolites will stop P-fimbriated E.coli bacteria from sticking to the walls of the urinary tract. If the bacteria cannot stick to the bladder, they will not grow or cause infection or produce biofilms.”

“This is much more specific than what EFSA calls the​ 'beneficial physiological effect of defence against bacterial pathogens'.”

Claim confusion

There was also confusion, Haesearts said, between the article 13 claim wording and that of an article 14 disease risk reduction rejection for Ocean Spray cranberry products from 2009.

The article 13 claim proposed: “The daily consumption of 36mg PACs of cranberry Vaccinium macrocarpon (measured by DMAC method) contributes to decreasing the adherence of certain uropathogenic P-fimbriated E.coli to the walls of the urinary tract.”

Ocean Spray proposed a more general claim that its products could, “help reduce the risk of UTI in women by inhibiting the adhesion of certain bacteria in the urinary tract”.

Haesaerts observed: “In our case, clinical evidence, including a favourable Cochrane Collaboration opinion, all point to effective anti-adhesion activity.”

Large sections of the medical fraternity, including the European Association of Urology, had backed cranberry PACs in the treatment and prevention of UTI, he said.

“Pharmatoka firmly believes in the positive contribution of cranberry and the bioactive PAC and intends to discuss further options with the European Commission and EFSA.”

The article 13 NDA opinion can be found here.

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