The European Food Safety Agency (EFSA) rejected Clasado’s latest digestive health application in June last year which Clasado appealed. This month EFSA responded by affirming its initial rejection.
The company said it was in discussions with UK Trading Standards to ensure marketing compliance on its website and other materials.
Clasado criticised the agency for being unclear about data requirements.
“Clasado maintains the view that Clasado provided strong and robust evidence for the claimed effect,” the firm said. “It is evident that there is a disconnect between EFSA’s opinion of what constitutes scientific proof and that of the wider scientific community.”
“Clasado also believes that that there remains a serious lack of transparency in the criteria adopted by EFSA in reaching their opinions. It is unfortunate that a practical understanding of EFSAs requirements appears to only be possible through a process of trial and error on the part of the company making the submission.”
Down but not out
The setback would not stop a fourth submission for its Bimuno prebiotic galacto-oligosaccharide (GOS).
“Despite these difficulties Clasado believes a positive health claim approval is still possible. Clasado has built up considerable experience of the process and a better understanding of EFSAs requirements which will aid in any future health claim submission.”
“Clasado will continue to add to its substantial body of positive scientific evidence through our longstanding and continuing programme of research with internationally respected research institutes including those at Oxford University and the University of Reading."
The submitted claim stated, “Regular daily consumption of 1.37 g galacto-oligosaccharides from Bimuno may reduce abdominal discomfort.”
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected Clasado’s assertion that its latest claim was specific only to bloating, flatulence and abdominal pain and not other gastrointestinal issues like abdominal migraine and functional constipation.
However the NDA disagreed, stating there was no combined measure of efficacy in the materials presented and so the claim assessed was in fact the more general claim as previously submitted in its previous rejected applications.
The NDA said, “this claim does not differ from that submitted in previous applications.”
Rejection grounds
The Panel stood by its previous findings that unmonitored medications taken by participants compromised study findings and that an inputational method (last observation carried forward (LOCF)) was prone to bias.
But it emphasised that it stood by its initial assertion that the key study was rejected because “it did not measure an appropriate outcome of efficacy as indicated in the previous sections.”
It said it referenced secondary outcomes in this application but not in a previous 2009 rejection of Clasado because the former study was underpowered.
“The Panel noted that the reported effects of BimunoGOS on three out of the five individual outcomes investigated (i.e. abdominal pain, bloating and flatulence) did not translate into a significant improvement of the subjects’ quality of life, and taken together these data would indicate inconsistency in the results.”