“So the NDA (Panel on Dietetic Products, Nutrition and Allergies) panel assessed maintenance of normal vision but took into account the many references provided by DSM to see how they could support a claim on normal vision.”
While DSM is referenced, the claim was a general function, article 13 claim that was rejected in 2009 and 2011. The “insufficient” conclusion prompted an NDA reassessment with additional data added to the dossier by DSM, its partner Kemin, but the NDA remained unimpressed.
Aside from being criticised for its methodology in rejecting peer-reviewed and validated intervention studies, it is its decision not to assess the claims submitted - claims that exactly mimic those approved by French authorities in 2004 – that is infuriating the lutein sector, none more than the biggest players, DSM and Kemin.
“…level of unclarity that's unprecedented…”
The companies sent us a statement expressing their frustration at the NDA’s trajectory on the matter, while remaining upbeat a claim could be won.
"The opinion of EFSA presents us with a level of unclarity that's unprecedented,”said DSM VP of nutrition and health, Bas van Buijtenen.
“EFSA has apparently come to the conclusion that the evidence on lutein and eye health is too strong to reject the claim: We have no doubt that EFSA would have given the claim an outright rejection if it had felt the evidence was too weak.”
“DSM and Kemin will seek dialogue with EFSA and potentially the commission to better understand the balance between a number of the factors identified in the opinion: What is the relative importance of the choice of the end-point, the claim wording and the evidence on the mechanisms?”
Kemin president Pedro Vieira added: "The dossier contained carefully selected references in relation with the specific antioxidant claim and not with a ‘maintenance of vision’ claim. Additionally, the Austrian Ministry of Health checked during one month the completeness of the dossier and did not object to the eligibility of the submitted claim."
Van Buijtenen said the companies would continue to battle to validate what they see as a very strong body of scientific work – the dossiers referenced more than 200 studies alone – and proposed a potential middle ground.
“Maybe a probational permission of the health claim is an appropriate reflection of the fact that for the second time, EFSA has not given the claim an outright rejection. Given the large body of evidence that already exists, as well as the large number of studies still underway, DSM and Kemin remain perfectly confident that EFSA will ultimately recognise the beneficial effects of lutein in the field of eye-health.”
NDA verdict
The lutein sector was pinning its hopes on the main addition in the resubmission - a study (LUXEA) of zeaxanthin and lutein supplements, and their accumulation in the eye.
But in dismissing it, the NDA observed, “that the visual performance study was not randomised, that no information was provided on how subjects were selected from the LUXEA study, that the statistical methods used for data analysis are poorly described in the publications, and that no information is provided about the baseline characteristics of the subjects for the variables of interest, or about their comparability between groups.”
“The Panel also notes that the final sample size analysed for visual performance outcomes is small, and that the study was likely to be underpowered for such outcomes.”
