Martek responds to rejected omega-3 health claim

By Shane Starling

- Last updated on GMT

Martek Biosciences Corporation is disappointed but not devastated by the European Food Safety Authority’s rejection of its article 14 DHA/ARA infant nutrition health claim.

The world’s leading docosahexaenoic acid (DHA) and arachidonic acid (ARA) supplier for infant formula, said it was focusing on the positive aspects of the ruling and would continue to build the science around its ingredients.

“We are disappointed because we felt the science we presented was strong but there are some positive aspects of the ruling and we are focusing on those,”​ said Martek senior public relations manager, Cassie France-Kelly.

These related to two studies demonstrating visual benefits in infants aged 6-12 months that have been breast fed until the ages of 4-6 months and then fed omega-3 and omega-6 rich DHA and ARA fortified formula.

“They found a pearl of usable science in these two studies so we are going to submit a revised claim around that and see where it gets us,”​ she said.

The claim EFSA rejected stated: “DHA and ARA support neural development of the brain and eyes.”

Martek will submit a response and further data during the 30-day consultation window that had opened for public comment since the opinion’s publication on September 26.

France-Kelly said the company continued to invest in science and was pursuing clinical trials demonstrating the health benefits of DHA and ARA for older infants.

Grounds for rejection

EFSA rejected the majority of Martek’s science because it deemed it irrelevant to the age period of the submitted health claim, which was between the ages of six months and three years.

In its verdict, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), found some of Martek’s data to be“not pertinent to the claim”​ because many of them focused on the effect of long chain polyunsaturated fatty acids on newborn babies.

While the health benefits were not challenged outright, the study period was “not representative of the target population”.

Literal approach

As was the case with EFSA’s other claim rejections (it has rejected eight of nine so far), Martek was surprised by what France-Kelly called an “overly literal approach”.

“Their approach is highly conservative,” ​she said. “We were not totally shocked by this after the first decisions came in. We are active on many fronts and these kind of claims are just one piece in the puzzle. We will continue to build the science in this area.”

She added: “To prevent companies from making claims about products that have solid science places a straight jacket on industry and withholds good information reaching the public. In this sense we are disappointed but it is not the end of the world.”

About one third of European infant formulas and follow-on formulas include DHA and/or ARA. Such fortification occurs more frequently in the US where Martek has a 95 per cent market share.

EFSA has about another 200 article 14 claims that deal with disease reduction and children’s health as well as about 2500 generic article 13 claims to process before the January, 2010 deadline.

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