InQpharm to File Appeal on EFSA Kidney Bean Ruling

BERLIN—In light of the European Food Safety Authority (EFSA) ruling concluding “insufficient evidence" for a weight reduction claim related to a white kidney bean extract, InQpharm Europe Ltd., the company that submitted the claim application, said it will appeal the ruling within 30 days.

The product in question is PhaseLite, a Phase 2 Carb Controller developed by Pharmachem Laboratories in the United States. The white kidney bean extract has GRAS (generally recognized as safe)—Pharmachem tested the product in 2003—status in the United States and two permitted structure/function claims for starch reduction and weight loss.

“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.

Hafner said he was surprised by the EFSA’a ruling that the testing has a bias risk. He also said the company didn’t get a chance to respond to the criticism, saying the company doesn’t believe there is a risk of bias because it followed the same procedures applied in drug studies throughout the world. Additionally, he said the peer reviewed journal Obesity published the study, and never said bias could have been a possible concern. (Nutritional Journal. 2011 March; 10:24. doi:10.1186/1475-2891-10-24)

“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," Hafner said. “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."