| |
| | US FDA/CFSAN - Qualified Health Claims: Letter of Denial - Xangold® Lutein Esters, Lutein, or Zeaxanthin and ... |
 | | In this instance, it is not necessary for FDA to determine whether lutein and/or zeaxanthin should be considered as subjects of the proposed claim, in addition to Xangold® lutein esters, because including studies of lutein and/or zeaxanthin does not change FDA's ultimate conclusion that the petition should be denied for lack of credible evidence. |
 | | Because serum and tissue lutein and zeaxanthin levels are poorly correlated with dietary intake, and many known and unknown factors can alter these levels, no scientific conclusions about the relationship between intake of Xangold® lutein esters, lutein, or zeaxanthin and risk reduction of AMD or cataracts can be drawn from these 9 studies. |
 | | Beta-carotene, lutein and zeaxanthin are members of the carotenoid family ("Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids," A Report of the Panel on Dietary Antioxidants and Related Compounds, Food and Nutrition Board of the Institute of Medicine, 2000). |
| www.cfsan.fda.gov /~dms/qhclutei.html (7009 words) |
|