2004Q-0180 - Qualified Health Claim (QHC): Lutein and Eye Disease
FDA Comment Number : EC6
Submitter : Mr. Michael Reuben Date & Time: 06/18/2004 04:06:36
Organization : H. Reisman Corporation
Dietary Supplement Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
We have 2 comments on the proposed claim language 'Consumption of 12 mg of Xangold lutein esters per day may reduce the risk of age-related macular degeneration (AMD) and cataract formation'
1) The reference to a brand name (Xangold) excludes all other brand names and suggests that this is an FDA endorsement of one particular brand over another. As I understand it this is not the function of the FDA.

2) The reference to lutein esters is self limiting and does not take into account the fact that free lutein as opposed to the lutein esters is the active molecule and it is this molecule that has been found in the macula, blood plasma etc. By allowing the proposed health claim it will be construed by the public that the FDA is endorsing the lutein ester, where as the vast majority of the scientific studies published by reputable and highly respected researchers, scientists, and academicians have been based on the free form of lutein.

In light of the above two comments we recommend that the FDA not allow the proposed claim in its current form. The allowable claim should be made for free lutein rather than lutein esters. Furthermore please note that free form lutein abounds in nature, specifically it is the predominant form of lutein in lutein rich foods eg, kale, spinach, broccoli, collards and other cruciferous vegetables.
With thanks for your consideration