The company had submitted a petition to the FDA in April 2004 but in a letter dated December 19, 2005 the agency said "there is no credible evidence to support qualified health claims for Xangold lutein esters, lutein, or zeaxanthin and reduced risk of age-related macular degeneration or cataract formation".
Christine Peggau, marketing manager at Cognis Nutrition & Health, said the firm was 'disappointed'. The result will also disappoint other companies marketing free lutein or zeaxanthin.
The agency underlined that although Cognis had submitted a claim related only to its own product, most of the available evidence supporting this product and submitted by the firm was derived from studies of lutein and/or zeaxanthin rather than specifically on Xangold lutein esters.
It therefore decided to "treat lutein and zeaxanthin, in addition to Xangold lutein esters, as subjects of the proposed claim", according to the letter from Barbara Schneeman, director of the office of nutritional products, labeling and dietary supplements.
This latest health claim denial will also be scrutinized by the makers of other ingredients looking for qualified health claims, a process that has been criticized by industry since its launch at the end of 2003. All petitions have been submitted to numerous delays and few qualified claims have been approved.
The FDA's investigation, including 12 intervention studies and 23 observational studies, concluded that scientific conclusions could not be drawn on lutein's relationship with AMD.
Some of the intervention studies did not include a control group while others focused on the treatment effect of lutein or zeaxanthin rather than the risk reduction of disease, noted the agency.
FDA also raised the problem of a lack of recognized endpoint to measure AMD risk. And in many of the studies, the subjects also consumed other nutrients that are thought to play a role in disease risk reduction, said the agency.
But Peggau believes that FDA's review of the lutein evidence demanded a high level of evidence, similar to that expected for an unqualified health claim.
"When the FDA reviewed the claim, they discounted all review papers, animal studies and epidemiological research," she told NutraIngredients.com."They focused solely on randomized, placebo-controlled human clinical trials."
"We feel the research is there to make the qualified health claim we were seeking."
Cognis is currently evaluating options on its next step and has not yet made a decision on whether it would re-submit a petition.
But like others in the industry, the firm is hoping that the process is made clearer in the future.
"Part of the problem is that FDA never defined what significant, scientific agreement is, which is the criteria for an unqualified health claim. So it would be helpful to have clear, defined guidelines on what scientific evidence is acceptable and unacceptable for each level of claim," added Peggau.
"Consumers are the real losers in today's story. But we believe that one day there will be a qualified health claim for lutein. The evidence is really strong," she continued.