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FOLIC ACID SURVEILLANCE PROGRAM TO MONITOR ADVERSE EVENTS

This article was originally published in The Tan Sheet

Executive Summary

FOLIC ACID SURVEILLANCE PROGRAM TO MONITOR ADVERSE EVENTS was unanimously supported by the Folic Acid Subcommittee of FDA's Food Advisory Committee at an April 15 meeting. The subcommittee recommended that a surveillance program be designed to gauge "the positive impact" of folic acid consumption and to "monitor [vitamin] B[12] deficiency and potential adverse effects to folic acid," Subcommittee Chairman Edward Brandt, MD/PhD, University of Oklahoma, summarized. The endorsement of a surveillance program for folic acid was linked to the subcommittee's recommendation to allow folic acid claims for reducing the incidence of neural tube defects (NTDs) (see preceding story). The advisory group also resolved that the food supply be fortified with folic acid. Centers for Disease Control and Prevention Birth Defects and Genetics Branch Chief David Erickson, PhD, told the subcommittee that CDC "will be happy to work in designing and implementing such a surveillance system and we will actively seek additional resources to do this." The "first priority of the system," he suggested, should be to "to detect adverse effects that may occur in persons with undiagnosed vitamin B[12] deficiency." CDC already has begun "to explore the feasibility of using Medicare data as the basis for such surveillance" in response to concerns that folic acid consumption among older adults may mask signs of vitamin B[12] deficiency, which can lead to pernicious anemia, Erickson said. The CDC official added that many state health departments have begun monitoring births and accumulating data on birth defects. FDA already has taken steps toward putting a folic acid surveillance system in place, Office of Special Nutritionals Acting Director Elizabeth Yetley, PhD, reported. "We have initiated some discussions with the National Center for Health Statistics to see about the possibility of including additional serum measures in the National Health and Nutrition Examination Survey" (NHANES), such as "serum B[12]," Yetley said. "Those kinds of activities we follow through on and pursue as well [as] we can," she continued, "and we will also work with other surveys within the National Center for Health Statistics" and hospital discharge surveys. To potentially get a better handle on the effects of folic acid supplementation in women of childbearing age, Roberta Carlin, Spina Bifida Association of America, pointed out that legislation is pending that would monitor all pregnancies in the U.S. to determine the incidence of birth defects including NTDs. The Birth Defects Prevention Act of 1993 (HR 1296) was introduced by Rep. Solomon Ortiz (D-Tex.) on March 10. A companion measure is expected to be introduced in the Senate shortly. The subcommittee also agreed that a general education campaign informing the U.S. population and health professionals about the risks and benefits of folate consumption should be undertaken. Outlining possible components of a folic acid education campaign, subcommittee chairman Brandt suggested that the USDA's Women, Infants and Children (WIC) supplemental nutrition and food stamp programs could "get the message across" at a "really minimal cost." Brandt also proposed that an educational program should be "in the context of total nutrition and not just increasing your daily folic acid intake if you're of childbearing age"; and should incorporate warnings for risky behavior for pregnant women, such as smoking cigarettes or consuming alcohol. Subcommittee member Jeanne DeJoseph, MD, University of California-San Francisco, urged "manufacturers [to] take it as their responsibility to encourage package inserts on things like tampons, sanitary napkins, [and] pregnancy testing kits" to educate women of childbearing age of the benefits of folic acid supplementation. DeJoseph also encouraged the use of "public service announcements and write-ups" in magazines such as Rolling Stone and Teen. Brandt further suggested that an educational plan should "enlist actively the cooperation" of CDC in "getting together practitioners who see both the elderly and women of childbearing age" so that they can encourage the use of folic acid among women and "actively seek out [vitamin] B[12] deficiency in the elderly" and "perhaps gather some data" on that. In a presentation to the subcommittee, Hoffmann-La Roche Senior Clinical Research Coordinator Adrienne Bendich, PhD, maintained that, "in addition to approval of a health claim and accompanying educational activities, there should be a concerted effort to increase availability of folic acid-containing multivitamins or fortified foods to the women most at risk." "Critical headway could be made through the WIC and food stamp programs" by designating folic acid a "priority nutrient" in the WIC program and offering WIC participants who "have given birth or completed lactation . . . folic acid-containing multivitamins in between pregnancies," Bendich suggested. As part of this effort, food stamp regulations should "be revised to include the purchase of folic acid-containing multivitamins," she continued, and "new programs can be initiated to distribute manufacturers coupons in high schools, Planned Parenthood and other clinics, as well as through churches." Council for Responsible Nutrition Technical Director Annette Dickinson, PhD, concurred with Bendich that folic acid supplementation "combined with free distribution of supplements to low income groups could potentially be as effective as [food] fortification in terms of reaching the target group" of women of childbearing age. Dickinson cited a program started by the Texas Department of Health last October that has been dispensing free folic acid-containing vitamins to any woman between the ages of 13 and 44 living in Hidalgo or Cameron Counties. These regions have been identified as having a high incidence of births with NTDs. Various dietary supplement manufacturers have been supplying the Texas health department with 30-, 60- or 90-day supplies of folic acid-containing vitamins. To date, over 315,000 bottles of supplements have been distributed at health department clinics, Planned Parenthood clinics and community health centers, with each individual receiving three bottles, according to Food Advisory Committee member Robert Sowards, head of the food branch at the Texas Department of Health. Sowards pointed out that the benefits of the program have not yet been measured because the health department has not been allocated funds for follow-up. However, the department is planning to request funding, he said. A public intervention program also has been under way since October 1992 in 14 of 46 counties in South Carolina, where, like Texas, there is a high incidence of NTDs.
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