In July 2014 we submitted a health claim application to the European Food Safety Authority (EFSA) and the EU Commission regarding the physiological effect of the two ingredients in Punalpin® (pomegranate and galangal). The purpose with this application was to achieve the right to claim the ingredients in Punalpin, i.e. to tell the customers, which effect the ingredients may cause in the body.
The application was substantiated by a placebo-controlled clinical study. EFSA recognizes the study results, but requests data from more Punalpin studies plus documentation on the mechanism of action. Thus we have received a rejection of our application. Altogether, we regard the opinion as being positive, since our clinical research has received a fine evaluation by EFSA and since it is commonly known that EFSA requires data from more clinical study before a health claim is authorized.
We are now preparing a new clinical study and expect to submit a new health claim application in 1½ year.