EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found causality had not been demonstrated between the consumption of Rudolf Wild’s Immune Balance Drink (IBD) and strengthening the body’s defences by supporting the immune system and reducing susceptibility to pathogens.
According to the opinion, the German company’s compound comprises 3.0 g/l green tea extract, 12.0 g/l grape skin extract, 0.5 g/l grape seed extract, and 0.05 g/l shiitake extract, 200 mg/l vitamin C, some additives, and flavouring agents.
Wild said it intends to clarify with the Parma-based agency the type of substantiation now required of the company in order to establish the cause-effect-relationship for the IBD.
Risk population trial
EFSA said that the one human interventionist study with IBD that Wild submitted can not be extrapolated to the claimed effect of strengthening the body’s defences in people without common cold infections.
In response, a spokesperson for Rudolf Wild told NutraIngredients.com that the company conducted its clinical trial four years ago, and, at the time the industry standard approach was to use populations at risk to demonstrate effect.
“It is not feasible from either a financial or time perspective for a company to carry out large scale general population trials to measure effects to substantiate claims for all its products,” he argued.
The spokesperson added that he envisaged there would be difficulty in capping the number of studies needed or qualifying the size of population required in such an approach.
The NDA said that the study submitted by Wild investigated the effect of IBD on the severity and duration of symptoms in individuals already suffering from common cold:
“The study with IBD was a double-blind, randomised, placebo-controlled, multicentre clinical study. In this study 98 patients, reporting common cold symptoms that began no longer than 24 hours before study intervention were randomly assigned to consume either 250 ml IBD or placebo twice a day for 6-10 days.
“The evidence provided does not establish that results obtained in studies on subjects with common cold infections relating to the treatment of symptoms of common cold can be extrapolated to the claimed effect of strengthening body’s defences by supporting the immune system and reducing susceptibility to pathogens in healthy people (without common cold infections)."
The Parma-based agency provided no further comment as to the conclusions of that study.
However, the company said that EFSA, contrary to the opinions it has issued in some other health claim applications, did not criticise the IBD study, other than the fact its cohort was too narrow, and Wild said it is interpreting this as a validation of the significance of the results found.
“The study proves that participants with a cold suffered less from the symptoms and that the symptoms wore off faster when they consumed 250ml of the Immune Balance Drink twice daily,” stated the company.
The opinion can be found here.
Health claims will be discussed at the NutraIngredients Health Claims 2010 conference to be held in Brussels on 10th December where the likes of Danone and Unilever will share their experiences with the process.