EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected similar dossiers containing 40+ studies, including a large number of “gold standard” trials, submitted by pharma and food giant, Merck Selbstmedikation.
In its dossiers, the German firm recommended mothers consume 200mg of DHA (docosahexaenoic acid) in the form of food supplements per day during and after pregnancy to confer the eye health and brain health benefits in the foetus and infant.
But the NDA said, “There is insufficient evidence to establish a cause and effect relationship.”
Global algae-sourced DHA leader, Martek Biosciences, had a similar DHA/ARA (arachidonic acid) dossier turned down last year, although the French arm of Mead Johnson Nutritionals had two omega-3, eye health claims approved by the NDA in March, while simultaneously having three infant brain health claims rejected.
Mead in February became the first company to have an omega-3, eye health, infant formula claim approved.
EFSA says no
The application referred to supplements that contained 50mg of EPA (eicosapentaenoic acid) and between 11.4 and 14.4 mg d-α-tocopherol, in addition to 200mg of DHA.
Merck submitted the same wording for each claim: “DHA is important for early development of the eyes/brain in the foetus (unborn child) and infant. Maternal DHA supply contributes to the child’s visual/cognitive development.”
The visual claim contained 41 studies, the brain claim, 48.
The cognitive development claim contained 25 human intervention and observational studies, three meta-analyses of human intervention studies, five systematic reviews, four other review publications, three guidelines/consensus opinions and eight mechanistic human studies.
But only seven human and observational studies were deemed relevant with EFSA taking issue with sample sizes, insignificant and inconsistent results as well as dosages that did not match those of the proposed claim.
In one randomised, clinical trial (RCT) of 29 pregnant women, the NDA said the small sample size, inconsistent findings for various intelligence tests including hand-eye coordination, problem solving and behaviour, and dose about 10 times the level of that recommended in the claim, and was therefore not “informative”.
It found similar problems with all of the other studies.
For the visual development claim, Merck submitted 15 RCT, one non-randomised controlled trial, two observational cohort studies, three meta-analyses of human intervention studies, five systematic reviews, four other review publications, three guidelines/consensus opinions and eight mechanistic human studies.
But NDA said most were not relevant.
“Intervention studies which assessed visual acuity in children who had been either breastfed or fed formula enriched with DHA are not regarded as pertinent for the substantiation of the proposed health claim, nor are RCT which describe the effects of DHA supplementation of pregnant women on the DHA concentrations in maternal and umbilical cord blood and in placenta and RCT conducted with DHA in lactating women which assess the effect on breastmilk DHA content,” it said.
Only five RCT trials and a cohort study were considered pertinent but it found them all wanting for the same reasons as described above.
The European Union is attempting to formulate a centralised list under the nutrition and health claims regulation that is due for completion in January, 2010.
To see the visual development opinion click here.
To see the cognitive development opinion click here.
Merck was unavailable for comment by the time of publication.