In light of the EFSA ruling concluding “insufficient evidence,” for a weight reduction claim related to an extract of the white kidney bean, InQpharm Europe Ltd, the company that submitted the claim application, said it will appeal the ruling within 30 days.
“While we were disappointed by the opinion, we were pleased they concluded that two of the three relevant requirements for the health claim were fulfilled and recognized two of our studies, issuing an opinion of ‘insufficient evidence,’ as opposed to ‘no evidence,’” said Thomas Hafner, CEO of InQpharm, a specialty pharmaceutical company and the leading developer and manufacturer of weight management products in Europe.
“The white kidney bean extract PhaseLite®, (Phase 2 Carb Controller® developed by Pharmachem Laboratories in the U.S.) is one of the most studied weight management ingredients on the market and we are confident that we can overcome their objections with additional data,” said Hafner. “The ingredient has GRAS status in the U.S. and two permitted structure/function claims for starch reduction and weight loss.”
Mitch Skop, senior director, new product development for Pharmachem, said: “We fully support InQpharm’s efforts, and will provide all possible assistance during the appeal process.”
Hafner said he was surprised by EFSA’s assertion that there was a risk of bias through and un-blinded interim analysis in one of the studies.
“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. 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 the analysis 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,” said Hafner. “There are many drugs on the market where the mode of action is not completely clear. Again, we feel that we can provide additional data to satisfy EFSA’s concerns.”