Kemin and DSM will carry out further studies to support health claim
After EFSA concludes that a cause and effect relationship has not been established between taking FloraGlo and Optisharp and improved vision in bright light
Kemin and DSM will continue to conduct and support further clinical evidence to reinforce the scientific basis for the positive impact of their FloraGlo lutein and Optisharp zeaxanthin products on eye health, in spite of the conclusion reached by the European Food Safety Authority (EFSA) that 'a cause and effect relationship has not been established between the consumption of a combination of lutein and zeaxanthin and improved vision under bright light conditions'.
The EFSA said DSM and Kemin had provided 10 published studies and one unpublished human intervention study to support their claim. Five studies investigated the effects of lutein and/or zeaxanthin on macular pigment optical density, but did not assess vision, whereas two studies investigated the effects of lutein only. Two further studies had already been evaluated in a previous assessment and 'no conclusions could be drawn from one further small (no effect) study', the EFSA said.
In a further trial with 'a large number of missing data owing to drop-out/non-compliance of study subjects', a combination of lutein and zeaxanthin had no effect on any outcomes of visual function in the population of subjects completing the protocol as planned, the EFSA said.
In weighing the evidence, the EFSA said that 'the one study from which conclusions could be drawn did not show an effect of lutein plus zeaxanthin on vision'.
According to Kemin and DSM, the positive effects of lutein and zeaxanthin on eye health and visual function, both through the protection of specific eye tissues and by increasing visual performance, have been affirmed by 'a significant and comprehensive body of evidence'.
They said the EFSA's opinion 'does not alter the ingredient’s regulatory status in Europe. It only means that our specifically proposed health claim cannot be used for the time-being', adding that FloraGLO Lutein and Optisharp Zeaxanthin 'retain their status as lawful ingredients that can continue to be used by our customers in their food supplements and food'.
The two companies will therefore continue to conduct and support further clinical research to reinforce the scientific basis for the positive impact of these products on eye health.
