EFSA refutes Danone health claims criticism
In a five-page letter to the European Commission’s Basil Mathioudakis, Dr Juliane Kleiner, the unit head of EFSA’s Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA), defended its initial opinion handed to Danone in December.
Danone’s reaction to that opinion can be found here.
Kleiner reaffirmed that:
- Symptoms reported in the key intervention study in Danone’s immunity-based dossier such as atopic dermatitis, recurrent wheezing and allergic urticaria did not necessarily indicate an allergic mechanism
- More information about antibiotic prescription was required to back claims of immune response in the same study
- That a lack of correction for multiple testing weakened the same study
- That increased bifidobacteria and lactobaccili in the gut did not necessarily have a beneficial physiological effect
- That a reduction in particular kind of bacteria (Clostridium spp) is an appropriate measure of pathogenic bacteria
- That bifidobacteria and lactobaccili levels found in stools were not associated with initiation of an appropriate immune response
- That animal data submitted was inappropriate to predict to human responses
- That its opinion followed the criteria and methods as specified in the 2006 nutrition and health claims regulation
Danone was not available to comment by the time of publication.
The trial in question was conducted on 259 infants (128 males) with a history of atopic dermatitis and other infections. It showed significant reductions in atopic dermatitis among the intervention group fed the Immunofortis 9:1 mixture of short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS).
After two years, atopic dermatitis (13.6% v 27.9%), recurrent wheeze (8% v 21%), allergic urticaria (1.5% v 10%) were significantly lower among those on the formula for the 134 infants who completed the trial.