EFSA denies reduced diarrhoea link for Actimel

EFSA has concluded that the positive elements included in the application filed by Danone in August 2009 are not sufficient to establish a definite relationship of cause and effect between the consumption of Actimel, containing the L. casei DN114 001, and a reduced risk of diarrhoea associated with the presence in the intestine of Clostridium difficile bacteria for older people undergoing antibiotic treatment in hospital environments.
EFSA’s opinion does not concern current communications for Actimel addressing the public at large and consumers in general, and naturally does not concern the sale of Actimel.
Commenting on the opinion, Danone co-chief operating officer Emmanuel Faber states: “Danone contests this opinion, which is in contradiction with the findings of a series of clinical studies, of which the most significant was published in the British Medical Journal, a prestigious scientific review that is internationally known for its strict editorial policies.
“That contradiction underscores the need, which Danone has pointed to on several occasions, for EFSA to amend evaluation processes and clarify the criteria for assessments of scientific evidence relating to specific products and drawing on the findings of recent clinical studies. These same observations were raised and reiterated by stakeholders attending the recent meeting on health claims related to gut and immune function organized by EFSA.”