She said EFSA’s ‘risk factor oriented’ approach had proved a major stumbling block for probiotic claim applicants relying on a body of science that measured several risk factors.
“If you look back at the studies that have been done with probiotics, they have measured several risk factors, which makes it difficult to build up a dossier based on one risk factor. From a scientific point of view, identifying several different markers strengthens the evidence but under EFSA’s system it actually weakens the case for being granted a health claim.”
It is a lesson that applies not just to probiotic claim applications, but to any failed health claim dossiers.
“It’s the most common reason for rejection of claims,” said Sarkkinen.
“Even if companies have done lots of studies on an ingredient or product, they may still have too few studies supporting a specific risk factor. The best approach is to decide what kind of claim you are targeting and then build up a dossier based around that, because it affects other factors such as the dosage levels and the target population.”
She added that another common failure factor is using old studies in which the doses vary to commercial use.
Scandinavians unite
Foodfiles AB was established in January this year, when Finnish nutrition-focused CRO Oy Foodfiles joined forces with KPL Good Food Practice AB, a Swedish firm that had developed an IT support system for recruiting and conducting clinical trials.
The new company has combined experience from conducting more than 170 clinical trials within nutrition and writing more than 70 regulatory dossiers, including many Novel Foods and health claims applications.
According to CEO Johan Olsson, Foodfiles AB strengths are its database of 6000+ subjects, and its IT system.
“We have an IT system that helps us to do large trials. Most organisations conduct studies on 50-300 participants. We can do anything from 10 to 550. A lot of companies see that as an advantage. The electronic system also means we can screen recruits more efficiently than our competitors, who have to do it by telephone.”
At present, he says the main areas where companies are looking to conduct clinical trials are cardiovascular disease, weight management and body composition, lipid metabolism, glucose and insulin metabolism, satiation, blood pressure and gut health and immunity.