OmniActive, Kemin Health and Cognis Nutrition and Health all issued statements expressing their obvious disappointment with the European Food Safety Authority (EFSA) verdict that found insufficient evidence linking lutein consumption and “maintenance of normal vision”.
Fellow eye health carotenoid, meso-zeaxanthin, was also handed a negative opinion by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), prompting OmniActive managing director Sanjaya Mariwala to tell NutraIngredients-USA.com it was time for the industry to, “come together” to win claims approvals.
“It is important for like-minded manufacturers of high quality carotenoids, antioxidants and nutritional ingredients to come together to make a focused effort to consolidate scientific arguments and better meet the nutritional needs of this century’s lifestyle and resource base,” Mariwala said.
Kemin Health vice president of global marketing Andrew Martin said the Iowa-based company was disappointed one of the, “most widely researched dietary ingredients used in supplements and foods” had failed to impress the NDA panel.
“Kemin is immediately taking steps to ensure that eye-health related claims will continue to be made on FloraGLO products,” he said, noting the ingredient was the subject of an ongoing age-related eye disease study that may bolster future submissions to EFSA or other agencies.
Last week, Holger Becker, PhD, Cognis Nutrition and Health’s global product manager for Xangold Natural Lutein Esters, noted his company had, “worked with other lutein suppliers to secure health claim approval for lutein products in Europe and will now address our future options.”
Omniactive’s Mariwala added: “We hope to learn from the experience, and bridge the information and data gaps to facilitate a fresh review of claims with the right level of justification.”
The NDA’s lutein opinion found that while the carotenoid had the ability to raise macular pigment density, this effect did not necessarily benefit, “maintenance of normal vision”.
The submission contained 232 references including 86 human studies, 42 of which were human intervention studies investigating either vision endpoints or lutein bioavailability.
There were also 36 textbooks or opinions from authoritative bodies; 57 narrative reviews; one comprehensive review that included seven randomised controlled trials (RCTs).
The NDA ruled out the studies on various grounds including small populations, poor trial design or the use of non-healthy populations.
It stated: “In weighing the evidence from these dietary interventions, the Panel notes that, although many of the interventions were in very small numbers of people and of poor design, it is established that supplemental lutein can increase macular pigment in most but not all healthy eyes. It remains unclear, however, whether such changes in macular pigment are associated with any beneficial physiological effect in the longer term. Rather the little evidence that was presented on the effect of dietary lutein on vision during the supplemental period is weighted strongly towards the conclusion that there is no functional benefit for healthy eyes.”
The NDA’s lutein opinion can be found here.