2004Q-0180 - Qualified Health Claim (QHC): Lutein and Eye Disease
FDA Comment Number : EC3
Submitter : Dr. Robert Abel Date & Time: 06/18/2004 04:06:50
Organization : Delaware Ophthalmology Consultants
Health Professional
Category :
Issue Areas/Comments
Lutein is the fundamental carotenoid found in nature which protects plants from sunlight. Lutein rich foods (which contain the more bioavailable free lutein form) have been shown to reduce the risk of macular degeneration. In fact an article in the Amer J Optometry 4/04 has indicated that free lutein has improved retina function in a placebo-controlled veteran study.
The proposed claim for esterified lutein appears to be restrictive when (1) few studies have shown lutein esters to be effective as free lutein, (2) all of the major eye studies and the majority of the multivitamins have chosen the free lutein(in fact FloraGlo brand) for inclusion , and (3) mg for mg the free form appears to be more bioavaioable.
I applaud your recognition of the lutein-maculoprotective relationship. I only encourage you to consider free lutein and lutein-rich foods in the label language. Thank you.
Robert Abel Jr MD, former clinical professor of ophthalmology.