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This article was originally published in The Tan Sheet

Executive Summary

FOLIC ACID HEALTH CLAIM SPECIFICALLY FOR DIETARY SUPPLEMENTS recommended by the Council for Responsible Nutrition in Dec. 13 comments to FDA on the agency's proposal to allow folic acid health claims for supplements and conventional foods ("The Tan Sheet" Oct. 11, p. 4). CRN urged FDA to "develop a [folic acid] health claim specifically for dietary supplements, recognizing the proven effect of supplementation in helping reduce the risk of [neural tube defects] and alerting women to the critical periconceptional period." A supplement health claim, the group argued, "should not be required to include information on dietary sources of folate, since supplements have been shown to be effective per se in reducing the risk of neural tube defects." CRN suggested that FDA "has never given consideration to a folic acid health claim unique to supplements despite the fact that all of the intervention trials have used supplements and all of the epidemiological evidence related primarily to women's use of supplements." Lederle recommended in Dec. 3 comments on the folic acid proposal that a dietary supplement health claim should be approved while FDA finalizes its plans to allow foods to be fortified with folate. While "we are not against food fortification with folic acid," Lederle said, "we may have to await careful study of how best to accomplish this, since there is some debate on the appropriate level of fortification." In the meantime, Lederle argued, there is "a simple, inexpensive and safe way to help women prevent" NTDs in their children. "No one has argued against or challenged the safety of recommending multivitamin supplements containing .4 mg folic acid for all women of childbearing age. We need to get on with our education of women about this important information," Lederle declared. CRN agreed, charging that FDA has held the "dietary supplement claim hostage to development of an overall plan for increasing folic acid in the food supply." CRN also proposed a sample folic acid health claim: "Women capable of pregnancy should consume .4 mg of folic acid -- a B vitamin -- each day to help prevent spina bifida and other neural tube defects." The group offered an optional statement that "it is especially important that adequate folic acid be consumed daily, one to three months before the pregnancy begins, and for the first few months of pregnancy." Regarding the amount of folic acid that should be advocated in a potential health claim, CRN said that FDA should not permit a health claim for any supplement that contains less than 400 mcg folic acid, and should increase the daily limit of folic acid that an individual can consume from 1 mg to 5 mg. The group pointed out that a 5 mg folic acid ceiling was recommended in a 1991 report by the Federation of American Societies for Experimental Biology as well as by the U.K. government in a policy recommendation on folic acid and NTDs. A 1 mg limit is "based on 50-year-old evidence which is irrelevant in view of current medical practice," CRN concluded. CRN also argued that "no health claim should be allowed for naturally occurring food folate." If FDA insists on allowing "such a claim, despite the paucity of scientific evidence supporting it, the claim should be allowed only for foods with at least 20% of the RDI for folate," CRN maintained. The group suggested that "a nutrient content claim would be preferable" for foods with naturally occurring folate. Lederle expressed concern about the agency's suggestion that a potential health claim state that "some but not all women may benefit from adequate intakes of folic acid." "It would be far more appropriate and educational," the company maintained, "to state the degree of risk" of conceiving a child with neural tube defects and the "approximate 50% reduction in incidence of NTDs by .4 mg folic acid." The "specific degree of reduction is a scientific finding and it seems inappropriate to withhold well-established scientific information from the consumer," the company argued. 1n a similar vein, Lederle disagreed with FDA's proposal to include a qualifier that NTDs are "not widespread." Such a statement, Lederle suggested, "will only lead many women to think, 'It is not common, and therefore it can't happen to them.'" Lederle also objected to a potential warning statement on safe upper limits of intake because it "would only serve to discourage supplementation at a time when the science is emerging on the important role of folic acid in optimizing good health." The firm added that a warning would be unnecessary because "dietary supplements containing .4 mg folic acid have been available for about 25 years" and the "safety of folic acid during this time has never been in doubt." CRN, in its comments to the agency, agreed that the warning "may in fact deter women from using products containing folic acid." Referring to FDA's proposal that folic acid health claims be prohibited on fortified products that contain more than 100% of the U.S. Recommended Dietary Allowance of vitamins A and D, Lederle pointed out that the statement should "clearly state that the retinol form of vitamin A" should be avoided, since "beta carotene is well-recognized to be safe at 100% RDI and at multiples many times 100% of the RDI." [More] In separate, Dec. 13 comments on FDA's proposal to disallow five health claims for dietary supplements ("The Tan Sheet" Oct. 11, p. 1), CRN said it will continue to urge the approval of all of the claims. The five claims explicitly disallowed by FDA were fiber and cancer; fiber and heart disease; antioxidant vitamins and cancer; omega-3 fatty acids and heart disease; and zinc and immune function in the elderly. CRN added that the zinc/immune function claim "should not be limited to zinc alone." Asserting that "there is significant scientific agreement" on the cited health claims among the "experts in the relevant fields of study," CRN charged that the "opinions expressed by the experts are being overridden by scientists and other staffers within the agency who are not as uniquely qualified in the particular research field being considered." CRN also asserted that FDA's Nov. 1-3 public conference on antioxidants "indicated significant scientific agreement about the relationship between antioxidant vitamins and cancer" and heart disease ("The Tan Sheet" Nov. 8, pp. 15-21).

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