FDA Denies Macular Degeneration Claims For Lutein, Branded Or Not
This article was originally published in The Tan Sheet
Executive Summary
FDA extended its denial of Cognis' qualified health claim petition for Xangold branded lutein esters to other forms of the nutrient, including zeaxanthin, the agency announced in a recent communication to the ingredient supply firm
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FDA extended its denial of Cognis' qualified health claim petition for Xangold branded lutein esters to other forms of the nutrient, including zeaxanthin, the agency announced in a recent communication to the ingredient supply firm. The amended claim linking lutein and/or zeaxanthin, in either free or esterified forms, to a reduced risk of age-related macular degeneration (AMD) and cataract formation was denied Dec. 19. Xangold is a mixture of 93% lutein diesters and 7% zeaxanthin diesters, according to Cognis' petition. Scientific conclusions could not be drawn from any of the available studies, according to FDA. Half of the intervention and many of the observational studies were discounted because they used a test substance that contained additional nutrients, such as multivitamins. Additionally, three of the 12 intervention studies evaluated the treatment of the two nutrients rather than their effect on reducing the risk of AMD or cataracts, which is the relationship characterized by a QHC. FDA stressed that it only considers studies on diseased individuals when there is evidence demonstrating that the mechanisms for treatment and risk reduction are the same, and that a substance affects these mechanisms the same way in both diseased and healthy people. Other reasons for exclusion included the lack of a control group and the measurement of an unrecognized surrogate endpoint, namely macular pigment density. FDA decided not to use a disclaimer, determining that no language would sufficiently prevent consumer deception, given the complete absence of credible evidence, the agency says. Expanding the subject of the claim was technically unnecessary because "including studies of lutein and/or zeaxanthin does not change FDA's ultimate conclusion that the petition should be denied due to lack of credible evidence," the agency states. However, FDA widened the petition's scope for two reasons: "the majority of the available evidence consists of studies of lutein and/or zeaxanthin rather than studies of Xangold lutein esters" and "many comments recommended that FDA not limit its consideration to Xangold lutein esters." Thirteen of the 15 comments submitted to the agency "were supportive of a qualified health claim regarding lutein and certain eye diseases but considered the subject of the petitioner's claim too restrictive," FDA says. The comments "indicated that the subject of any authorized claim should be lutein and/or lutein-containing foods instead of lutein esters." Additionally, four of the 13 comments "went further and also opposed the use of a brand name in a qualified health claim," the agency notes. Naming a specific brand could negatively affect public health by "unnecessarily" restricting use of a beneficial claim; it might also "suggest" that the agency endorses a certain company, the comments reason. La Grange, Ill.-based Cognis objects to FDA's approach to evaluating the claim. The firm submitted the Xangold petition to FDA in April 2004 (1 (Also see "Xangold Lutein Qualified Health Claim Sought By Cognis" - Pink Sheet, 24 May, 2004.), p.16). "FDA 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," says Christine Peggau, Marketing Manager, Cognis Nutrition & Health. "Despite the rigid controls used in the human trials, FDA ultimately decided not to issue a QHC based on its restrictive review of the evidence," Peggau concludes. The "science is strong," Peggau asserts, pointing out that NIH's National Eye Institute is funding an upcoming study to evaluate the impact of lutein/zeaxanthin and omega-3 supplementation on the development of AMD and cataracts. Cognis has not yet decided what step to take next, but the firm is "evaluating all options regarding the FDA's opinion," according to Peggau. Meanwhile, "Cognis invites industry colleagues to work with FDA in suggesting improvements so the process for QHCs ultimately benefits the consumer as it was designed to do," she says. The agency recently held a public meeting to evaluate the efficacy of QHCs after an FDA study found that current qualifying language "confused" consumers (2 (Also see "Qualified Health Claim Testing May Draw On FTC Study Findings" - Pink Sheet, 12 Dec, 2005.), p. 4). - Katia Fowler |