Going over recent EFSA opinions on health claim applications it is amazing to notice that still companies do not fully realize what it takes ‘to tango’ a health claim. What a waste of time and money!

Should you already have prepared a dossier, run an independent pre-submission check (see my previous post). But even when only study reports and data are available, an independent, expert feasibility assessment sheds light on the question whether or not to proceed with compiling and filing an application. This is sometimes advertised as a gap-analysis.

However, a mere superficial examination of the available data will not provide for a reliable gap analysis. Only after having thoroughly scrutinized the available evidence one can judge whether a gap exists in the data or not. There is no other way!

Moreover, the advantage of this approach is that if it is subsequently decided to proceed to compile the full dossier, most of the work for Part 3 of the dossier (scientific substantiation) has already been done. So, if you are in doubt about the strength of your data… don’t hesitate and have a thorough, independent feasibility assessment been performed. It will save you time and money!