2004Q-0180 - Qualified Health Claim (QHC): Lutein and Eye Disease
FDA Comment Number : EC5
Submitter : Dr. Paul Bernstein Date & Time: 06/18/2004 04:06:18
Organization : Moran Eye Center, University of Utah
Academia
Category :
Issue Areas/Comments
GENERAL
GENERAL
It has recently been brought to my attention that the FDA is considering a health claim that lutein esters may reduce the risk of macular degeneration and cataracts. As a retina specialist and researcher with many years of experience in the carotenoid field, I am supportive of this claim, but I feel it is too restrictive unless unesterified lutein is also included. Esterifed lutein must be cleaved to lutein prior to deposition in the macula. Many food sources and currently available supplements contain free lutein rather than lutein esters, and they appear to be similarly bioavailable. Allowing a claim for lutein esters but not for free lutein will needlessly confuse the public on this important public health issue.


Paul S. Bernstein, MD, PhD