The president of Danone Baby Nutrition (DBN) says European Food Safety Authority (EFSA) health claim assessment methodologies are threatening the reputation of the scientific peer-review process and sections of the medical fraternity.
In a 22-page defence of DBN’s Immunofortis prebiotic formula-based, infant immunity claim which EFSA rejected in early February, Christian Neu said the opinion is a cause for, “disappointment and concern”.
“This goes beyond the interests of DBN,” Neu wrote. “It also regards the effect of this public opinion on the reputation of the external scientists which worked directly on, or peer-reviewed the science. Likewise, it affects the reputation of the community of medical advisors who support the health effects of the mixture referred to above [Immunofortis].”
NutraIngredients coverage of the opinion of EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) on DBN’s “naturally strengthen the baby’s immune system” claim can be found here.
Neu’s letter to the European Commission (EC) goes on to call for scientific dialogue with EFSA to, “create a transparent and stable regulatory environment” to foster research.
“The current process endangers the continuation of such research and development,” Neu wrote.
A Hungarian researcher involved in one of the studies that formed part of DBN’s dossier, also wrote to the EC about the NDA opinion.
“It would be nice to come to some kind of common view [on] just what kind of evidence might be suitable to establish the immunomodulatory effect of prebiotics,” wrote Dr Tamás Decsi, a professor of paediatrics at the University of Pecs in Hungary. “Such agreement might even be useful in the ongoing dispute over probiotics as well.”
He added: “It would be a shame if the story were to end here with the message that might be all too easily translated by the media as, ‘no effect of prebiotics’.”
Danone’s letter also referenced another paediatrics professor, a Dr Petter Brandtzaeg from Oslo University, who had contributed to the scientific literature in the prebiotic area, including an influential study on infant immune response biomarkers (endpoints).
“In my opinion the arguments for the claim seem to be convincingly by the literature provided,” professor Brandtzaeg wrote.
Danone’s issues in detail
Neu’s letter contained a detailed deconstruction of the NDA opinion which included criticism of the NDA’s failure to:
- substantiate ‘generally accepted scientific evidence in the paediatric field’
- consider the ‘totality of evidence’
- consider studies in combination, rather than individually
- comment on all studies submitted
- indicate how it weighed the importance of studies in the DBN dossier
Neu said the NDA’s focus on atopic dermatitis, infections and reduction of pathogens as surrogate endpoints did not represent the totality of the science submitted.
Other endpoints such as the composition of intestinal microbiota; potential pathogen numbers; faeces pH and plasma immunoglobulin levels should have been given more consideration.
He said EFSA had failed to meet its commitment from June last year to communicate more with applicants about, “alternative claims instead of a rejection of the science altogether”.
“DBN has not had the benefit of exploring this with EFSA in this case and is of the view that the process should have included a dialogue about this.”
The NDA opinion for babies up to 12 months of age found Danone’s 30-trial strong dossier wanting for containing limited, inconsistent and irrelevant trial data.