In other action, the FDA has denied a qualified health claim for lutein esters and a reduced risk of age-related macular degeneration and cataracts.
The health claim petition was filed by Cognis Nutrition & Health in March 2004 for consumption of its Xangold brand lutein esters.
Christine Peggau, global segment manager for Cognis, said the company was naturally disappointed. "But," she said, "This is not the end of the story."
"We believe that one day there will be a qualified health claim for Xangold. The FDA's decision was based on the science behind free lutein, lutein esters and zeaxanthin — not just Xangold Lutein Esters.?
"The FDA's evaluation of the science discounted review papers, animal studies and epidemiological studies and focused on the clinical studies using standards similar to those used to evaluate pharmaceuticals, not nutritional ingredients."
Compelling science exists for lutein esters, free lutein and zeaxanthin, Cognis said.
"Lewin Group estimates five-year net savings of $2.5 billion from avoided transitions to dependency associated with a reduction in the relative risk of AMD through daily intake of 6-10mg of lutein with zeaxanthin," Peggau said.
"According to the findings, across the five-year period, approximately 98,219 individuals could avoid the transition to dependence, either in the community or a nursing facility, that would accompany a loss of central vision resulting from advanced AMD."
The research is continuing. The National Eye Institute, a division of?the National Institutes of Health, is funding an upcoming study of lutein and zeaxanthin.?NIH has two other studies currently under way examining the link between lutein and eye health.
Cognis has not yet decided whether it will re-file its petition. In the meantime, "We are inviting industry colleagues to work with the FDA in suggesting improvements so the process for qualified health claims ultimately benefits the consumer, as it was designed to do," said Peggau.