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This article was originally published in The Tan Sheet

Executive Summary

FOLIC ACID HEALTH CLAIMS FOR NEURAL TUBE DEFECT PREVENTION WILL BE ALLOWED by FDA under an agency proposal slated for publication in July, FDA said in a June 15 release. In announcing the June 18 publication of proposed regulations implementing the Nutrition Labeling & Education Act for dietary supplements, the agency noted that "in July, FDA intends to publish proposals authorizing a health claim and amending the food additive regulation for [use of] folic acid" in the prevention of neural tube defects (NTDs). FDA said it will obtain advice from the agency's Food Advisory Committee, the Folic Acid Subcommittee and "experts who have been advising the agency on this topic" at "approximately mid-point" in the 60-day comment period of the July proposal. FDA's Folic Acid Subcommittee recommended in April that the agency allow products to claim that daily intake of 400 micrograms of folic acid -- in either dietary supplements or fortified foods -- can reduce the risk of conceiving a child with NTDs ("The Tan Sheet" April 19, p. 3). The dose of 400 mcg of folic acid is available in most over- the-counter multivitamins. FDA noted that "antioxidant vitamins will be the next area given priority" after folic acid. The agency said it expects to publish a notice in the Federal Register "incorporating by reference" the 1991 health claim proposal and 1993 final rule on antioxidants and the prevention of cancer, which "found the supplement claim [was] not adequately supported." In addition, FDA said it "plans to cosponsor with other research and health organizations an open symposium to discuss the available science, to identify any unmet research needs, and to discuss ways of facilitating research to meet these needs." The agency said it "will consider the results of this symposium in deciding whether to authorize a health claim on antioxidant vitamins and cancer." The July notice also will call for comments and new data on antioxidants and cancer prevention. Among the antioxidant vitamins (C, E and beta carotene), FDA has indicated that it is especially interested in evaluating health claims for vitamin E, particularly following recently published studies showing a cardioprotective benefit for the antioxidant. At a recent meeting sponsored by the New York State Bar Association, for example, FDA Office of Food Labeling Director Edward Scarbrough acknowledged that the agency would have to revisit data on vitamin E to determine whether it merits a health claim ("The Tan Sheet" June 7, p. 8). In general, FDA promised to "work with food and supplement manufacturers and the scientific community on additional health claims that should be permitted on labels." To that end, FDA is considering cosponsoring a symposium similar to the one for antioxidant vitamins to address health claims for dietary fiber and the prevention of heart disease and cancer. A July notice also will call for comments and new data on dietary fiber health claims, and note that FDA has not previously authorized health claims for dietary fiber and heart disease/cancer. In addition, FDA will provide the opportunity for comment and new data on health claims for omega-3 fatty acids and heart disease, and for zinc and immune function in the elderly. Both health claims have not previously been allowed by FDA. Criteria for evaluating health claims for dietary supplements would be the same as for conventional foods, including that there be agreement among "qualified experts" that the claims are scientifically valid. Allowing health claims for folic acid and considering other nutrient-disease relationships indicates a willingness on FDA's part to go beyond the health claims allowed for conventional foods under the NLEA (see preceding story). The accepted claims for foods that will also be allowed for dietary supplements are: calcium-osteoporosis, sodium-hypertension, dietary fat-cancer, and dietary saturated fat and cholesterol and coronary heart disease, with calcium-osteoporosis being the only relevant claim for supplements.

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