EFSA health claim opinions

Non-fermented fibre wins tooth claim; cranberry may need to find new tract


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"...an encouragement to Roquette to make headway on other projects."
"...an encouragement to Roquette to make headway on other projects."

Related tags Urinary tract Urinary tract infection

Non-fermented carbohydrates can deliver tooth health benefits but there is not enough data to show cranberry can benefit urinary tract infections, the European Food Safety Authority (EFSA) has found in a new series of health claim opinions.

The agency’s  Panel on Dietetic Products, Nutrition and Allergies (NDA) gave the thumbs up to French supplier Roquette for its Nutriose non-fermented fibre which it concluded could help tooth mineralisation when replacing fermentable carbs.

The NDA said, rather specifically, “in order to bear the claim, ‘fermentable’ carbohydrates should be replaced in foods or beverages by ‘non-fermentable’ carbohydrates, so that consumption of such foods or beverages does not lower plaque pH below 5.7 during and up to 30 minutes after consumption, and does not lead to dental erosion.”

The full opinion, which follows earlier positive opinions about sweetener replacement and tooth health, can be found here​.

"This is the first health claim​ attributed to Nutriose and the EFSA opinion is an encouragement to Roquette to make headway on other projects," ​said Bertrand Rodriguez, scientific communication manager in R&D at Roquette.

Cranberry player: “...[we've been] been knocking on the wrong door.”

Cranberry was not so fortunate. French cranberry supplements firm Pharmatoka expressed disappointment at having its proprietary urinary tract infection (UTI)-benefitting claim rejected via article 13.5 of the nutrition and health claims regulation (NHCR).


Pharmatoka president-founder Gunter Haesaerts, who won a similar claim in 2004 in France, told us, We regret their decision which we and our experts consider not scientifically justified for a food supplement.”

Despite the presence of an in vivo study specific to Pharmatoka’s Urell food supplement, the NDA said it could not draw any positive conclusions from the study or the rest of the dossier and so rejected it.

More technically it said, “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.”

The study found two capsules of Urell day decreased bacterial load in the urinary tract but the NDA countered, “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.”

Haesaerts said, “The participants of the study, of very old age, belonged to the most difficult populations to assess , which should have allowed  for the results to be extrapolated to the general population.”

Population extrapolation

But EFSA has indicated on many occasions indicated that population extrapolation is a very difficult thing to achieve.

Haeaerts added: “The in vivo study being rejected, EFSA would not take all other studies and information that was bundled in the dossier into consideration.”

“This is more in line with a pharmaceutical approach and in contradiction with the NHCR which mentions evaluation based on the totality of the studies presented.”

“Obviously, EFSA expects clinical studies that have the same quality and dimension  as required  to petition for  herbal medicines.”

“So it appears after all that Pharmatoka with its food supplement Urell, has been knocking on the wrong door.”

The NDA opinion is here​.

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