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The dossier’s key study was an unpublished study began in 2009 which showed increases in macular pigment optical density but was discounted by the NDA because of a high drop rate, missing data, a late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.