Lutein and zeaxanthin intakes and risk of age-related macular degeneration and cataracts: an evaluation using the Food and Drug Administration's evidence-based review system for health claims.

The labeling of health claims that meet the significant scientific agreement standard and of qualified health claims on conventional foods and dietary supplements requires premarket approval by the Food and Drug Administration (FDA). The FDA conducts an evidence-based review to ascertain whether sufficient evidence exists to support a significant scientific agreement standard or a qualified health claim. The FDA recently reviewed intervention and observational studies that evaluated the role of lutein and zeaxanthin in reducing the risk of age-related macular degeneration and cataracts. On the basis of this evidence-based review, the FDA concluded that no credible evidence exists for a health claim about the intake of lutein or zeaxanthin (or both) and the risk of age-related macular degeneration or cataracts.