After three previous rejections, the article 13.5 proprietary and emerging science submission under the EU nutrition and health claim regulation (NHCR) sought a new angle on the lutein-carotenoid-eye health link – aiming for a “younger and healthier population” as Pedro Vieira, global VP of eye and skin health at Kemin told us this morning.
“What this opinion shows is the ongoing pharma criteria applied to food supplements,” Vieira said.
After previous rejections, the company won’t be bothering with a formal appeal but will send a public letter to the European Commission highlighting its concerns with the opinion.
“But this opinion changes little for us – it would have been nice to have claims for healthier and younger people as the science shows here – but we move on and we will continue to invest in science. That will never change at Kemin.”
The proposed and rejected claim, submitted to EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) in October 2013, was: “Lutein together with zeaxanthin helps maintain clarity and contrast of sight in bright light conditions.”
The dossier’s key study was an unpublished study began in 2009 which showed increases in macular pigment optical density but was discounted by the NDA because of a high drop rate, missing data, a late change in data analysis methods and the fact visual outcome measures were secondary outcomes.
Kemin-DSM provided explanation to NDA questions during a stop-the-clock procedure but the panel's opinion remained unchanged about the study and the overall quality of data.
See the full NDA opinion here.
“we are working on our priorities.”
Vieira said now the NDA opinion was in, the study would be submitted for peer review.
DSM Nutritional Product’s Jens Birrer agreed with Vieira that the opinion was not the end of the world, that the European carotenoid market remained buoyant and that scientific and marketing investment continued around the lutein, zeaxanthin and other ingredients.
He also noted the fact the key study was commissioned in 2009, when the NHCR’s requirements were only just becoming apparent, meant it was more unlikely to drive a successful NDA verdict.
“Definitely guidance is clearer nowadays,” Birrer said. “We are working with Kemin on a new study.”
“But we are working on our priorities. The European market is developing nicely but also it is not the only market.”
Vieira pointed to lutein-eye health approvals in Canada.
Before superseded by the NHCR, lutein had won two approvals from the French Food Safety Agency (ANSES) that stated:
- “Lutein helps protect the retina and the lens from oxidation”
- “Lutein is one (of the) constituent(s) of the retina and the lens”
Aside from the 2012 rejection, the NDA rejected lutein dossiers referencing more than 200 studies in 2009 and 2011 and 2012.
Lutein and some other carotenoids are most strongly linked in the scientific literature with reducing the onset of advanced macular degeneration, which tends to affect older people.
The link between lutein and eye health was first reported in 1994 by Dr Johanna Seddon and her co-workers at Harvard University, who found a link between the intake of carotenoid-rich food, particularly dark green leafy vegetables like spinach, and a significant reduction in AMD (JAMA, Vol. 272, pp. 1413-1420).