Mud in your eye: EFSA rejects vision and stool claims


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Not enough beta-palmitate, youngster?...
Not enough beta-palmitate, youngster?...

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Replacing vegetable oils with an esterified vegetable oil in infant formulas will not soften infant stools, and a choline form will not boost vision, the European Food Safety Authority (EFSA) has found.

Beta-palmitate and softer stools – “weak” evidence

In the first of two new opinions, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) rejected beta-palmitate (a structured triglyceride with more than 50% palmitic acid) as a stool softening agent when replacing vegetable oils in infant formulas.

Specialised Nutrition Europe (SNE - formerly IDACE) had proposed the claim that such oil replacement, “contributes to soften the stools, which helps to increase their frequency.”

Of 19 human and non-human publications the NDA highlighted two. One found formula with 50% palmitate significantly increased stool softness compared to a version with 12% palmitate. But the NDA noted the difference was wiped out when solid foods were added to the diet.

The panel said the study had a high drop-out rate, a high rate of non-compliance but acknowledged it showed, “an effect of beta-palmitate in formula on softening of stools.”

But it wrote off another 12-week human intervention study that found no difference in the consistency of stools between two groups of infants fed formulae with 44% and 14% of beta-palmitate.

In rejecting SNE’s proposition the NDA said the overall evidence was, “weak”.

The NDA opinion can be found here​.

The Panel had previously rejected beta-palmitate’s ability to increase calcium absorption​ in another children’s health application under article 14 of the EU nutrition and health claims regulation (NHCR) application.

After publication SNE president Roger Clarke got in touch and said the opinion was not entirely unexpected as it had been submitted among many dossiersat the beginning of the NHCR process in 2008. 

Subsequent learnings meant that, "the conclusions drawn by EFSA given the state of science are fairly correct."

"If and when further science becomes available a resubmission could be contemplated."


Cytidine 5-diphosphocholine and normal vision – healthy population extrapolation fail

Italian supplements and medical devices manufacturer Omikron Italia sought to link a compound, cytidine 5-diphosphocholine (CDP-choline), that appears in some of its eye health products to the maintenance of normal vision.

Omikron submitted its dossier under article 13.5 of the NHCR that protects proprietary data but was rejected as the NDA said Omikron had failed to demonstrate how data gathered on elderly populations with eye health issues could be extrapolated to a healthy population.

The firm had however suggested the claim was relevant to, “subjects predisposed to retinal and post-retinal damage (> 65 years old, unbalanced diet, subjects with high myopia).”

 ​Its dossier contained eight human intervention studies, three reviews, and three non-human studies.

This product was a solution of 500 mg of CDP-choline (a mononucleotide consisting of cytosine, ribose, diphosphate and choline) that delivered 102 mg of choline per day.

In rejecting the claim, the NDA said measures like visual evoked potential (VEP) and pattern of  electroretinogram (PERG) did not evaluate the  claimed effect (i.e. visual function) in vivo ​in humans.

A stop-the-clock enquiry did not resolve the matter. “The Panel considers that, whereas visual field assessment is a direct outcome measure of vision, VEP and PERG are used to assess the integrity of cells and nerves involved in visual function but are not measures of vision.”

It concluded: During the evaluation process, the applicant was requested to clarify how results obtained in subjects with presumed damage to the retinal ganglion cells ( neurons found in the retina) and/or optic nerve owing to glaucoma or to an ischaemic event could be extrapolated to the target population (i.e. healthy subjects without damaged retinal ganglion cells or optic nerve) for which the claim is made.”

“The Panel notes that no evidence, which could justify the extrapolation of the results obtained in patients with glaucoma or with a non-arteritic ischaemic optic neuropathy to the target population, was provided by the applicant.”

The opinion can be found here​.

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