EFSA should rethink immunity claim opinion, says Wild
Wild’s research and development director, Matthias Sass wrote to the European Commission’s Director General of Health and Consumer Protection (DG SANCO) via representative, Lars Korsholm, calling on EFSA to engage in a “scientific discussion” about the rejected article 13.5 proprietary and emerging science claim.
“We therefore would like to initiate a scientific discussion on (1) the representativeness of the study population for the general population and (2) the extrapolation of data obtained in subjects with common cold infections to the general population…”
The claim sought to link consumption of a beveraege – Immune Balance Drink – containing a mostly antioxidant-based green tea extract, grape skin extract, grape seed extract, shiitake extract and vitamin C and strengthened bodily defenses. EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) opinion of Wild’s submission can be found here.
Extrapolation
In his letter, Sass said the NDA should not have discounted some studies just because they related to only particular components of the beverage, and more generally, whether or not studies could be relevant to ‘normal’ populations when studies were performed on specific populations.
“Given that a considerable percentage of the general population experience episodes of impaired immune defence as evidenced by the high incidence of infectious diseases like common cold infections every year, it seems plausible to consider the study population as representative target population, i.e. people at risk,” Sass wrote.
He noted the difficulty of conducting trials on healthy populations to determine preventative effects.“Clearly, it seems not feasible from both a financial or scientific perspective to carry out large-scale general population trials to measure immune stimulating effects in healthy and well-nourished people,” he wrote.
He added that poor dietary habits that could contribute to weakened immune systems were another factor that had been undervalued by the NDA.
In its health claim submission, Wild proposed that Immune Balance Drink could, “strengthen body’s defences by reducing infectivity of pathogens and stimulating immune response”.
It suggested seven immunity-related wordings for the claim, an approach it has subsequently been revealed is unlikely to win favour with the NDA.
The NDA highlighted the lack of studies on healthy populations and the drink itself, in stating the submission had not demonstrated causality.
The rules governing antioxidants and health claims will be one of many topics discussed at the upcoming conference, NutraIngredients Antioxidants 2010: Science, Testing and Regulation. For more information about the conference, please click here .
