09 Jun 11 EFSA rejects 86-study strong Valio probiotic gut health claim
In what may be the most contentious rejection yet, EFSA’s health claims panel has refused Valio’s gut health dossier based on the Lactobacillus rhamnosus GG (LGG) strain (used in products such as Valio’s Gefilus, the first clinically-backed probiotic consumer product on the
European market), that included 45 human studies and 41 non-human studies for failing to demonstrate causality.
Frustrated Finnish dairy and ingredients firm Valio says the European Food Safety Authority (EFSA) rejection of its probiotic claim contradicted or ignored peer reviewed data in its dossier that included 86 studies.
Valio development manager Dr Tuula Tuure said the company would appeal the opinion in the 30-day window open to it, and highlighted the depth of research on the strain that included 600 published studies, 38 doctoral dissertations, and about 50 immune-specific studies.
Finnish dairy and ingredients group Valio submitted 45 human studies and 41 non-human studies in its dossier for a claim that the strain could help, “to maintain defence against intestinal pathogens”.
But EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found the studies insufficiently strong to back the claim.
“In weighing the evidence, the Panel took into account that only one out of five human intervention studies showed an effect of LGG consumption on the development of GI infections, and that two human intervention studies did not show an effect of LGG consumption on the stimulation of protective immune responses after oral (viral) vaccination,” the NDA concluded.
“On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of LGG and maintenance of defence against pathogenic gastrointestinal microorganisms.”…..
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EC offers rejected probiotic health claim hope with resubmission offer
The European Commission is giving member states the opportunity to submit new data to back general function, article 13.1 probiotic claims rejected for being insufficiently characterised.
More than 200 general function probiotic claims have been rejected by the European Food Safety Authority (EFSA) health claims panel over the four batches it has so far produced. Many dossiers were not scrutinised because the probiotic strains were deemed insufficiently characterised.
Now the EC is offering hope to those rejected submissions, along with those where EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) drew an “insufficient evidence” conclusion rather than an outright, “cause and effect has not been established” condemnation of the data.
A three-month window that opened on June 1 and closes on September 30 will allow stakeholders to submit data to member state bodies who than have a further month to scrutinise and forward the data to the EC…..