EFSA rejects Yakult and Danone probiotic claims again

The European Food Safety Authority (EFSA) health claims panel says there are no grounds for alteration of its rejection last year of probiotic health claim dossiers submitted by Danone and Yakult.
In separate letters issued recently, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), says assessment of post-opinion comments about the NDA’s opinions from Danone, Yakult and others did not demonstrate causality to, “change the conclusions of the NDA Panel.”
Yakult’s emerging science, article 13.5 dossier sought to link consumption of its Lactobacillus casei Shirota (LcS) strain and maintenance of defenses against upper respiratory tract infections (URTIs), via a boosted immune system. It contained 15 studies, 12 of which were peer-reviewed, and ten of which were human intervention trials. Danone
Danone’s rejected dossier sought to link Lactobacillus casei-containing Actimel with a reduction in Clostridium difficile toxins in the gut and therefore a reduction in, “the incidence of acute diarrhoea.”
In its letter of last week, the EFSA maintained that the blinding issues discounted the trial findings. The NDA maintained data on C. difficile toxins was not conclusive, that data imputation scenarios were not comprehensive enough, that the grounds for rejecting supporting studies such as lack of controls were relevant, and that bioavailability studies, “did not show a reduction of gastrointestinal infections or gastrointestinal pathogens.”