‘Highly unsatisfactory’: Probi takes claim complaints to EC

‘Highly unsatisfactory’: Probi takes claim complaints to EC

The European Commission has asked the European Food Safety Authority to consider concerns raised by Swedish supplier Probi about the treatment of its rejected probiotic health claim.In July EFSA rejected Probi’s article13.5 health claim stating “Lactobacillus Plantarum 299V increases non-heme iron absorption” because of “insufficient” evidence.It said evidence for the effect was “inconsistent” and “at risk of systematic bias” addingthere was “no evidence” for a plausible mechanism in vivo in humans.At the time Probi said it would not take the rejection as the final word on the dossier.Yet the company’s CEO Peter Nählstedt told us that if it failed to overturn the rejection it would have to assume it is impossible to secure a health claim for probiotics given its claim was the 310th such dossier so far to have been snubbed.The company has now followed through on its initial reaction by writing to the Commission about its objections.“We strongly question the way this opinion has been treated by the [EFSA] panel. The absence of qualified scientific evaluation, on several occasions, of the information submitted to the panel, is to us highly unsatisfactory,” the company wrote in the letter sent to the Commission at the end of August and now forwarded onto EFSA. The Commission told EFSA: “Before considering further steps on this matter, and given that the above-mentioned comments relate to scientific matters for which EFSA is responsible, we would like EFSA to examine them, and let us know whether they are likely to modify the conclusions of the relevant opinion.” Speaking with us this week about the development Nählstedt said: “Probi does not agree with the EFSA panel’s conclusion that a cause and effect relationship could not be established. Therefore we do wish to see that the case is re-considered by the Commission.”In March Swedish manufacturer Bringwell launched a probiotic for boosted iron absorption using Probi’s FerroSorb. Against all odds? Yet – as with the likelihood of a probiotic claim approval – the odds of securing any changes from EFSA are against Probi.NutraIngredients understands there have only been two occasions when EFSA has changed a claim opinion after publication: once because of an administrative oversight after which the weight loss claim was still rejected and a second time for a reworked submission after an initial rejectionof a claim for prunes and bowel movement.Claim challenge Yet Probi says its grounds for a challenge are solid.It told the Commission that four out of the six of the studies submitted showed an effect on non-haem iron absorption and added the remaining studies should be considered as “clearly supportive” of the claimed effect.It agreed that results from two of the studies were different, but said it had explained this was because the bacteria used was not in a “comparable active state” with the second study using a bacteria added lyophilized to a cold product with a low pH.Yet it said EFSA did not acknowledge this explanation.Probi also questioned EFSA’s statement that one of the studies had methodological limitations because the “test and control foods differ in characteristics other than the Lp299v content which may have affected non-haem iron absorption”.EFSA’s Dietetic Products, Nutrition and Allergies  panel said “the relative effects of Lp299v vs differences in organic acids on non-haem iron absorption have not been quantified”.Yet Probi said it did not understand why there was no scientific evaluation of the potential effect of the differences in organic acids content on iron absorption, “rather than just a statement”.“We furthermore find it strange that the ‘methodological limitations’ claimed by the panel were not specified – if other than differences in organic acids – and to what extent it affects the overall assessment of the study.” Probi says these concerns were not raised in the first or second stop-the-clock procedure meaning the issue could not be addressed before the claim was rejected.©iStock/shironosovBias backlash The ND…

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