InQpharm Europe’s dossier under the EU nutrition and health claims regulation (NHCR) contained four human intervention trials but did not draw a positive verdict from the European Food Safety Authority’s (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA).
It said one study was, “at risk of bias.” Another “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.”
Peer review is not NDA review
InQpharm Europe CEO Thomas Hafner said his firm was disappointed not to be able to respond to the accusations of bias before the opinion went public.
“We didn’t get a chance to respond to this criticism, and feel there is no risk of bias because we followed the same procedures applied in drug studies throughout the world,” he said.
“We will provide EFSA with information on the conduct of the analysis to overcome these concerns. Furthermore, the study was published by the peer-reviewed, and highly respected journal Obesity, and at no time was this raised as a matter of possible concern.”
He added: “We were also a little surprised that EFSA questioned the mode of action of white kidney bean extract since there is solid evidence demonstrating that the ingredient inhibits alpha amylase, the enzyme that digests starch.”
Inqpharm’s submission referred to a proprietary extract called PhaseLite developed by US firm Pharmachem Laboratories.
“…we are confident that we can overcome their objections with additional data,” said Hafner.
“The ingredient has GRAS status in the US and two permitted structure/function claims for starch reduction and weight loss.”
Mitch Skop, senior director, new product development at Pharmachem, said: “We fully support InQpharm’s efforts, and will provide all possible assistance during the appeal process.”