Clasado ‘surprised and disappointed’ by latest EFSA prebiotic rejection; promises action

The firm was “surprised and disappointed” ​by the latest scientific rebuff, which came after dialogue with the agency during stop-the-clock procedures in the assessment process.

The company will respond with, "a number of areas of concern regarding the EFSA assessment itself”, ​Clasado said.

PR Neil Hunter told us “eyebrows had been raised” and the company would respond in the 30-day period for comments afforded to applicants after EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA)  hands down its verdicts.

Clasado believed it had a strong chance to win the EU’s forst prebiotic health claim due to the presence of a new, unpublished intervention trial involving more than 400 subjects across four European nations.

Too subjective?​

But theNDA said the gut health assessment methods were too subjective.

“…a combined measure of efficacy which would indicate whether the intervention provided adequate relief of symptoms of gastro-intestinal discomfort, was not assessed, and that measures of individual gastro-intestinal symptoms through validated questionnaires may only be used as supportive evidence for the scientific substantiation of health claims on the reduction of gastro-intestinal discomfort,”​ the panel said.

Bimuno is Clasado’s trademarked transgalactooligosaccharide.

The opinion can be found here​.

White kidney bean & weight loss ​

Also rejected by EFSA this week was a submission from InQpharm Europe in the UK linking white kidney bean (Phaseolus vulgaris​ ​L.) and weight loss. Four human intervention trials did not sway the NDA which concluded of the key study that while it showed a weight loss effect, it was, “at risk of bias.”​

It added a supporting study, “suffered from methodological limitations and that no evidence was provided for a mechanism by which the standardised aqueous extract from white kidney bean could exert the claimed effect.”​

That opinion is here​.

DoubleBad​

Swedish firm DoubleBad was also rejected for a submission for a insulin response influencing formulation containing L-threonine, L-valine, L-leucine, L-isoleucine, L-lysine and chromium picolinate.

Double Bad said the blend could stimulate, “insulin release via the insulinogenic properties of the amino acids in the food”.​

The NDA said, “the evidence provided by the applicant does not establish that a reduction in post-prandial glycaemic responses achieved by an increase in insulin secretion is a beneficial physiological effect for the target population in the context of this application.”​

The opinion is here​.