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This article was originally published in The Tan Sheet

Executive Summary

FOLIC ACID HEALTH CLAIM TO PREVENT NEURAL TUBE DEFECTS ENDORSED for dietary supplements and foods by a slim majority of the Folic Acid Subcommittee of FDA's Food Advisory Committee. At an April 15 meeting, the subcommittee voted 6-4 to recommend that FDA allow health claims stating 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 neural tube defects (NTDs). The dose of 400 mcgs folic acid is available in most over-the-counter multivitamins. The Food Advisory Committee was briefed on the subcommittee's recommendation at an April 16 session, but will not take up the issue until the panel's next meeting. In the interim, FDA plans to send a list of questions to outside scientific experts to determine their opinions on the risks and benefits of folic acid health claims. The subcommittee based its support of NTD prevention claims on several studies that showed a reduction in the incidence of NTDs when folic acid supplements were consumed on a daily basis. One study by Martha Werler, Boston University, et al., published in the March 10 issue of the Journal of the American Medical Association, found that the relative risk of first-time NTDs decreased 60% among women taking multivitamins containing folic acid (400 mcgs) during the periconceptional period ("The Tan Sheet" March 15, p. 15). Committee member Barbara Alving, MD, Walter Reed Army Research Center, Washington, D.C., suggested that health claims "might help make women and physicians much more aware of the need for adequate nutrition, for care of one's body during . . . the childbearing age." She speculated that a health claim might benefit older adults as well. Support of health claims is a reversal of the subcommittee's previous position. At a November 1992 meeting, the group rejected health claims linking folic acid supplements with NTD reduction. Regarding the specific language of the health claim, Alving commented said she would "trust FDA to work out the complexities." Alving also predicted that dietary supplement manufacturers will "exert a very high level of responsibility" when making claims in order to avoid a product liability problem. "They're going to have to be very careful," Alving suggested, "otherwise they're going to be sued for: 'I had a baby with NTD and you said I'd be okay if I took this pill.'" Possible wording for a folic acid health claim was provided by Hoffmann-La Roche Senior Clinical Research Coordinator Adrienne Bendich, PhD. She suggested that labeling could read: "In order to reduce the risk of certain severe birth defects, it is recommended that all women in the United States who are capable of becoming pregnant consume daily a multivitamin supplement or fortified breakfast cereal containing 400 to 800 micrograms of folic acid." In an FDA "options document" released at the meeting, the agency outlined that, per the 1990 Nutrition Labeling & Education Act, "elements of a health claim could include" statements: that would "enable women to understand the relative significance of the claim in the context of a total daily diet"; that women "who are capable of becoming pregnant should consume .4 mg of folic acid per day for the purpose of reducing their risk of having a pregnancy affected with spina bifida" or other NTDs; that would indicate that "total folate consumption should be less than 1 mg/day"; that use of folic acid "will confer no risk reduction for other serious birth defects" besides NTDs; that stresses the importance of complying with folic acid intake during the periconceptional interval; and that "some but not all women may benefit." Subcommittee member Mary Moore, MD, Einstein-Moss Arthritis Center, Philadelphia, suggested that an additional warning be included in any claim: "It is not known what folic acid may do to a patient who's on anti-folate medication" and that folic acid- containing dietary supplement consumption "should be discussed with your doctor." FDA Office of Special Nutritionals Acting Director Elizabeth Yetley, PhD, pointed out, however, that the NLEA guidelines for devising health claims for folic acid are, at present, only applicable to conventional foods and not dietary supplements because the 1992 user fee law prohibits FDA from implementing the NLEA vis a vis dietary supplements until Dec. 15. Those subcommittee members who were opposed to allowing a health claim for folic acid cited a lack of definitive scientific evidence in support of the claim. They also pointed out that folic acid consumption can occasionally mask the hematologic manifestations of vitamin B[12] deficiency, which can lead to pernicious anemia and nerve damage. Dennis Bier, MD, Washington University School of Medicine, St. Louis, acknowledged that "there is a body of knowledge, but it has some limitations." Bier also complained that subcommittee members were treating health claims for folic acid as if they were for drugs, but without the data to back them up. "If we came in with that product to another [drug advisory] committee of the FDA, they would say, 'Go away and bring back more data'" supporting the claim, Bier remarked. In response to subcommittee comments about folic acid hiding signs of vitamin B[12] deficiency, audience member Leon Ellenbogen, PhD, head of nutritional science at Lederle, attempted to assuage concerns. "The masking of pernicious anemia . . . is overblown . . . It is extremely rare that they've found patients masking pernicious anemia even at an old age in less than a milligram or two" of folic acid, he said. The subcommittee had discussed the issue at its November meeting and concluded that there are insufficient data to gauge the potential risk of folic acid consumption on those who are vitamin B[12] deficient. The subcommittee also reiterated a recommendation made at the November meeting that the food supply -- mostly grain-based products -- should be fortified with folic acid to carry out a 1992 Public Health Service recommendation that all women of childbearing age should consume 400 mcgs of folic acid daily to reduce the risk of conceiving a child with NTDs. Hoffmann-La Roche's Bendich pointed out, however, that fortifying the food supply will take a while. In the interim, she recommended that the use of folic acid-containing dietary supplements be encouraged. Bendich's position echoes comments made to FDA by the Center for Science in the Public Interest in February. CSPI urged that an "interim health claim for folic acid supplements be authorized while the agency crafts a food fortification strategy ("The Tan Sheet" March 1, p. 10).

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