EFSA health claim opinion

EFSA on omega-3 claims: yes to eye health, no to brain

By Shane Starling

- Last updated on GMT

Related tags: Dha, Docosahexaenoic acid, Nutrition, Clinical trial, Nda

The French arm of Mead Johnson Nutritionals has had two omega-3, eye health claims approved by the European Food Safety Authority (EFSA), but had three infant brain health claims turned down by the scientific assessor.

Mead in February became the first company to have an omega-3, eye health, infant formula claim approved by EFSA and the latest article 14 positive opinions add strength to that approval although these vindications relate to two of its proprietary ingredients – Enfamil and Lipil.

The eyes have it

The previous approval related the omega-3 forms, docosahexaenoic acid (DHA) and arachidonic acid (ARA), to eye health in infants up to the age of twelve months, with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), determining DHA, but not ARA, could benefit infant “visual development”.

The latest positive opinions are similar, with the NDA noting that many of the studies contained in the Enfamil and Lipil dossiers were the same as those submitted in the previous claim.

The Lipil and Enfamil dossiers contained 43 studies including 12 randomised, clinical trials, which in its former decision, led NDA to conclude DHA could benefit infant visual development of infants from birth to twelve months of age and in formula containing at least 0.3 per cent of total fatty acids comprised of DHA. As before, it found evidence supporting ARA wanting.

The NDA’s opinion on Mead’s initial claim can be read here​ .

No to brain benefits

In regard to three brain claims – one generically for ARA and DHA and one each for Enfamil and Lipil – the NDA found causality had not been demonstrated despite the fact Mead had submitted more than 30 studies it deemed relevant, including 13 original, randomised clinical trials used across all three claims. DHA dosage varied across the trials from 0.1 per cent to 0.9 per cent.

Many of these trials were conducted in infants up to 12 months of age, and therefore not in the claimed age bracket of up to three years. The NDA noted two of them had no effect on neurodevelopmental indices measured with different methods as compared to standard, unsupplemented formulas”.

Another two studies showed no differences in two independent psychological scores.

Only one randomised, double-blind, clinical trial noted “higher intention scores at 10 months of age than infants who received the unsupplemented formula”, ​but this study alone was deemed insufficient to demonstrate causality, because of the limited age bracket.

Three other studies were conducted on infants up to three years with either 0.3 per cent DHA alone or combinations with ARA. One study showed mental benefits but they were not sustained beyond two years; another using an ARA/DHA blend found no difference between the control group at 18 months; while a third found no significant differences in Psychomotor Developmental Indices and Behaviour Rating Scale but IQ benefits at four years.

While acknowledging a potential positive effect of, “supplementation on neurodevelopment indices infants as compared to unsupplemented formulas”​ the NDA said “the different testing ages and the use of different tests for assessment limit the comparability of the studies.”

It added: “The predictive value of the neurodevelopment tests used is uncertain. Indeed, only two of the studies above show an effect beyond the supplementation period, and only one reports a sustained effect beyond the first year of life in a limited sample of subjects. In no case the breastfed reference group showed lower developmental indices when compared to any formulated group.”

Mead was unavailable for comment at the time of publication.

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 EFSA’s latest Mead opinions click here​.

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