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This article was originally published in The Tan Sheet

Executive Summary

FDA DELAY IN APPROVING FOLIC ACID HEALTH CLAIM CRITICIZED BY SEN. BOND (R-Mo.) in a statement submitted to the record of a May 18 hearing of the Senate Appropriations/agriculture subcommittee. Sen. Kit Bond charged that "FDA has been slow, despite the overwhelming evidence, to approve the use of folic acid to prevent spina bifida and neural tube defects." FDA has been considering a health claim under the Nutrition Labeling & Education Act that daily consumption of 400 mcg of folic acid by women of childbearing age can reduce the risk of conceiving a child with neural tube defects. "We talk a great deal about the importance of preventive medicine in this country, particularly as we debate health care reform," the senator stated. "Yet when it comes down to the individual steps to prevent birth defects," he argued, "we seem to to be falling short." What "is the status of FDA's review" of allowing health claims for folic acid "and what is delaying FDA's action?" he asked. Sen. Bond asserted that "there is a growing body of evidence that points to the utility of folic acid supplements in the prevention of spina bifida and other neural tube defects." Noting that birth defects are the "leading cause of infant mortality," he pointed to his own work "to increase our efforts for birth defect surveillance and prevention efforts." Bond introduced the Birth Defects Prevention Act of 1993 (S 917) on May 6 to "provide surveillance, research and prevention services aimed at prevention of birth defects through the Centers for Disease Control." S 917 is a companion measure to Rep. Solomon Ortiz' (D-Tex.) birth defects prevention bill, HR 1296, which was introduced in the House on March 10 ("The Tan Sheet" April 19, p. 4). Sen. Dale Bumpers (D-Ark.) queried FDA Commissioner David Kessler about a potential folic acid health claim at the May 18 hearing. "Is there a proven connection," he asked Kessler, "between the use of a folic acid-containing multivitamin supplement taken during the earlier weeks of pregnancy and the prevention of birth defects?" Kessler acknowledged that "there certainly is strong epidemiological evidence" to support use of folic acid during pregnancy. The FDA commissioner added that he "made sure [his] wife was taking multivitamins in the early phases of pregnancy." Kessler declared that "there is no question that all women of childbearing potential should make sure that they have appropriate nutritional intake." Sen. Bumpers also asked Kessler if he would be in favor of taking "jurisdiction over advertising in foods" from the Federal Trade Commission and giving it to FDA. Nutritional information "needs to be accurate with regard to both advertising as well as labeling," Kessler responded. "The American public just [does not] want to be misled," he maintained, "and it doesn't make a difference who does it." Expediting approval of a birth defects health claim for folic acid supplements or fortified foods was urged by Hoffmann-La Roche Senior Clinical Research Coordinator Adrianne Bendich, PhD, in an April 26 letter to Edward Brandt, MD/PhD, chairman of the Folic Acid Subcommittee of FDA's Food Advisory Committee. Bendich, who proposed possible wording for a folic acid health claim at an April 15 meeting of the subcommittee ("The Tan Sheet" April 19, p. 3), complained that the full Food Advisory Committee was not given the opportunity to make recommendations on the issue at its April 16 meeting. However, the Folic Acid Subcommittee recommended at the meeting that FDA should allow the birth defect health claim for folate, that a surveillance program to monitor adverse events associated with folic acid be established, and that an educational campaign informing the U.S. population about the risks and benefits of folic acid consumption should be undertaken. She noted that the Federal Register notice announcing the meeting said that the Food Advisory Committee would "act on the Folic Acid Subcommittee" recommendations. However, "this did not occur," she stated. "Why did the advisory committee not act? What was their rationale?" Food Advisory Committee" about health safety issues relating to a folic acid health claim. "If the health claim for folic acid and neural tube defects is limited to multivitamins or fortified cereals containing [400 mcgs] of folic acid, there is no safety issue with regard to vitamin B[12] deficiency," she said. "Many such products have been on the market for decades with no evidence whatsoever that they have contributed to any increase in the incidence of neurological damage associated with vitamin B[12] deficiency in the elderly or black female population." "It is a matter of deep concern that the Food Advisory Committee has been exposed to undue negative input" on folic acid health claims, Bendich claimed, "which could result in a prolonged delay in reaching its recommendations." Even with a unanimous recommendation in favor of a folic acid health claim by the committee, "there is no guarantee that FDA will act," she concluded. FDA currently is devising a list of questions related to the issue that will be distributed to folic acid researchers and other experts for comment. A meeting of the Food Advisory Committee will be scheduled after comments are received and processed by the agency.

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