Dispatches from VitaFoods Europe 2013
EFSA sets standard for study rigor, consultant says
Differing regulatory environments can play havoc with a company's research plans, say consultant Joerg Gruenwald, PhD. But recent, sometimes bitter, experience with the European Food Safety Authority has shed some light on how to negotiate this tangle, he said.
In ruling on health claim applications, EFSA is requiring a significantly higher level of statistical power that FDA has generally asked for when vetting health claims in the US, said Gruenwald, who is the principal of Berlin-based consultancy and contract research organization analyze & realize. While this wasn't always clear at the outset of the health claims process several years ago, the situation has become more sharply defined with time, Gruenwald said. Companies seeking health claims in both Europe and the US can save time and frustration by planning their trials from the start to meet the EFSA standards.
