Responding to comments submitted to the European Commission by Equazen’s Swiss-based owner, Vifor Pharma (Potters), EFSA health claims unit head, Dr Juliane Kleiner, methodically addressed the company’s criticisms, and dismissed all of them.
Vifor Pharma’s major criticisms were that EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) should have:
- proposed a reworded claim to match the available evidence if it was the panel’s view the submitted claim was inappropriate
- been more specific about the evidence it required to validate the claim when in communication (twice) with Vifor Pharma during the dossier assessment process
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Verbal working memory
In response, Kleiner wrote that the NDA had not suggested an alternate wording as it had done with a tomato extract-blood platelet aggregation claim, that initially had been submitted as a blood circulation claim by UK company Provexis, because it did not consider the evidence strong enough to do so.
Vifor Pharma suggested that the NDA should change its submitted claim to more specifically mention verbal working memory, to reflect the science.
Its submitted claim stated: “Eye Q (a unique combination of Hi-EPA/DHA/GLA omega-3, 6 PUFA) provides the essential nutrients that help improve working memory in children.”
Data requirements
Vifor Pharma said there was a lack of transparency in data requirements to substantiate a health claim, in terms of when diseased populations for studies are relevant, the requirements for dose-response relationships to be established, as well as the demonstration of plausible mechanisms of action.
The company said these criteria were not being applied evenly, and cited a positive claim linking alpha-linoleic acid (ALA) and children’s brain development where a single study with a gun-shot wounded girl had been viewed favourably by the NDA. Similarly studies performed on those with irritable bowel syndrome have been deemed pertinent for digestive health claims by the panel.
Kleiner wrote that Vifor Pharma’s suggested plausible mechanisms: incorporation of polyunsaturated fatty acids in cerebral membranes and modulation of pro- and anti-inflammatory cytokine production were backed by “weak” data. Kleiner agreed with Vifor Pharma that plausible mechanisms were not, “mandatory for substantiation of the claim” but was, “supportive and is taken into account when weighing evidence for substantiation.”
Similarly for dose-response relationships Kleiner said there was no requirement they be established, and nor had there ever been, but again such evidence could be supportive.
She said corroborating data Victor Pharma had provided demonstrating the effect of the supplement in healthy children aged 11-14 and 16 years of age was dismissed due to the fact it was presented in the form of a press release. Other supportive studies were deemed weak or irrelevant to the proposed working memory claim.
Kleiner said the ALA claim had been approved because the gun-shot study added to, “a consensus among scientific experts” that did not exist for the proposed Eye Q claim.
Both sets of comments will be taken into consideration by the European Commission and member states when scrutinising the NDA opinion before approving or amending it for the EU law books.
In its opinion, the NDA found causality had not been demonstrated between the intake of Eye Q and the improvement of working memory in children of 6-12 years of age. That opinion can be found here.
Eye Q is a combination of the n-3 polyunsaturated fatty acids (PUFAs), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), and the n-6 PUFA, GLA (gamma-linolenic acid).