Kemin and DSM Nutritional Products affirm the significant and comprehensive body of evidence supporting 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. In October 2013, Kemin and DSM submitted a dossier pursuant to the article 13.5 of the EU regulation 1964/2006 on health claims, seeking authorization for the claim: “Lutein and zeaxanthin help maintain the clarity and contrast of sight in bright light conditions.” The dossier, based on proprietary data, included a new, unpublished human intervention study.

This double-blind, placebo-controlled and randomized human study was conducted over the course of one year at the University of Georgia in healthy individuals representative of the general population. Using an oral dose of 10 mg of lutein plus 2 mg of zeaxanthin per day, the study found that supplementing lutein and zeaxanthin significantly increased macular pigment optical density (MPOD), and in turn improved photo stress recovery and contrast energy in the intention-to-treat population. Furthermore, MPOD was closely and positively associated with these visual performance parameters. These results were recently presented at the International Carotenoids Society Meeting in Utah, U.S. by the principal investigator B. Randy Hammond, professor of behavioral and brain sciences at the University of Georgia, and will be the subject of a future peer-reviewed publication.

“To visual scientists, the fact that macular pigment affects visual function is accepted as an axiom. This is the basis for how most methods for measuring macular pigment operate: to wit, the methods are based on how macular pigment influences the behavioral response to a visual stimulus,” said Hammond.

This study confirms the results from an earlier trial conducted at the same site with an open label design. More importantly, it demonstrates that a cause-effect relationship exists between the ingestion of lutein and zeaxanthin, increases in MPOD and the resulting meaningful visual benefits. The study’s findings are consistent with epidemiological studies published in the last decade.

Furthermore, Hammond stated, “The idea that intraocular filters, like macular pigment, can improve vision under bright light conditions is supported by literally hundreds of empirical studies from diverse areas of inquiry. Increasing macular pigment through supplementation or diet, leads directly to a change in visual performance. This is the very reason why humans, like other animals, evolved mechanisms for accumulating retinal carotenoids in the first place.”

Lutein and zeaxanthin act as antioxidants and blue-light filters having protective and functional effects within the eye in both healthy people and patients suffering from degenerative eye diseases. Recently the Age Related Eye Disease Study 2 (AREDS2) reported significant benefits for patients with advanced age-related macular degeneration (AMD) and who received 10 mg FloraGLO® Lutein and 2 mg OPTISHARP® Zeaxanthin daily when compared to subjects who did not receive these two ingredients.

Lutein antioxidant and eye protection claims are currently authorized in several regions across the globe, including Canada (Natural Health Products Division of Health Canada in 2011), Brazil (Brazilian Health Surveillance Agency in 2008) and South Korea (2007).

The opinion issued by the European Food Safety Authority (EFSA) on lutein and zeaxanthin and improved vision 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. 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.

Kemin and DSM continue to conduct and support further clinical research to reinforce the scientific basis for the positive impact of FloraGLO Lutein and OPTISHARP Zeaxanthin on eye health.