The European Food Safety Authority (EFSA) health claims panel rejected that claim because it said mechanisms of action had not been adequately demonstrated, and that an ad-hoc analysis that adjusted for seasonality variables did not in fact remove potential diagnostic error.
The company has learnt from that rejection in designing a new trial central to its new EU nutrition and health claims regulation (NHCR) article 13.5 dossier that found statistical significant results that its Yestimun yeast beat-glucan could boost defenses against pathogens in a general population of 18-80 year-olds.
Business unit director in health and functional food, Eike Hagemen, told us EFSA gut and immunity guidance had been followed and made the company realise it had to focus on endpoints like pathogen reduction rather than any particular mechanism of action.
“The incidence of infections is a suitable outcome measure to demonstrate effects of the body’s defence against pathogens. Since a common cold is a viral infection we got the direct loop to the primary outcome of our study design.”
He said the company had used EFSA’s application help desk to refine its claim from, “defence against pathogens”, to, “…helps to maintain the body’s defence against pathogens in the upper respiratory tract.’
“The help desk was very useful. They are more settled now – people know what to do and they were very fast in their response. They looked over the complete dossier and responded in two weeks.”
Trial design
The revised study ran from November to March and had 170 finishers selected from patients attending seven Berlin private surgeries.
The study recorded a 16.7% reduction in colds and flus, which Hagemen noted was higher than for the typical 9-10% reduction reported in much echinacea research.
“We will show that you can win an EU claim without blood parameters. We don’t want to produce everything in Europe and then sell to Asia and that is why this health claim is important.”
EFSA’s opinion is expected next year.
The first study can be found here.
Leiber has 125 employees and has been working in yeast extracts for 60 years and has about 50% of its business in animal nutrition and 50% in human nutrition. It recently established a healthy ingredients division.
Yestimun is mostly used in food supplements and dairy products like infant formulas.