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Date: Feb. 29, 1996 FOR IMMEDIATE RELEASE Contact: Judith Foulke (202) 205-4144, Home (703) 451-8132
U.S. food manufacturers will add the nutrient folic acid to most enriched breads, flours, corn meals, pastas, rice and other grain products to reduce the risk of neural tube birth defects in newborns, as a result of action taken today by the Department of Health and Human Services and the Food and Drug Administration.
Folic acid, or folate, reduces the risk of neural tube birth defects such as spina bifida when consumed in adequate amounts by women before and during early pregnancy. Spina bifida is a common disabling birth condition resulting from failure of the spinal column to close.
"This is an important step in helping to prevent some of the most significant birth defects affecting Americans," said HHS Secretary Donna E. Shalala. "It is a balanced approach, based on our best scientific understanding to date regarding the role of folic acid in our diet. And it reflects hard work by all the Public Health Service agencies to protect our childrens' futures."
The Public Health Service recommended in 1992 that all women of child-bearing age consume 0.4 milligrams of folic acid daily to reduce their risk of giving birth to children with neural tube defects. As part of the Public Health Service strategy to achieve that goal, the FDA fortification rule is aimed at increasing folate intakes.
"Women of child-bearing age should eat a diet rich in leafy dark green vegetables, citrus fruits and juices, and lentils, or take a multivitamin a day to assure adequate levels of folic acid," said Dr. David A. Kessler, Commissioner of Food and Drugs. "In addition, by fortifying grain products, we are making it easier for women of child-bearing age to achieve adequate folic acid levels in their diets."
Under the new FDA rules, specified grain products will be required to be fortified with folic acid at levels ranging from 0.43 milligrams to 1.4 mg per pound of product. These amounts are designed to keep daily intake of folic acid below 1 mg, because intakes above that amount may mask symptoms of pernicious anemia, a form of vitamin B12 deficiency which primarily affects older people. If untreated, pernicious anemia can lead to severe permanent nerve damage.
Because over half of all pregnancies are unplanned and because these defects occur in the developing fetus before most women know they are pregnant, it is important that all women of child-bearing age consume the needed 400 micrograms (.4 mg) of folic acid daily.
In addition to fortified grain products, PHS recommended that women should obtain this amount through food sources and/or a dietary supplement (such as a multivitamin), or a combination of these sources.
According to David Satcher, M.D., Ph.D, Director , Centers for Disease Control and Prevention (CDC), "CDC estimates that there are approximately 4,000 pregnancies each year, including 2,500 live births, that are affected by spina bifida and other neural tube birth defects. We are pleased that the action taken today by FDA to fortify grain products with folic acid will help prevent many cases of these serious birth defects affecting the spine and brain."
Foods required to be fortified are: enriched bread, rolls, and buns; all enriched flour including bromated and self-rising flours; enriched corn grits and corn meals; enriched farina and rice; and all enriched macaroni and noodle products including vegetable macaroni, vegetable noodle, and non-fat milk macaroni products. In addition, breakfast cereals can add folic acid up to 400 mcg per serving.
Also under the new rules, manufacturers will be allowed to make claims on the labels that the fortified products contain folate or folic acid and that adequate intake of the nutrient has been shown to reduce the risk of neural tube birth defects.
FDA will review any new data concerning optimum fortification levels for folic acid and will consider adjusting the level of fortification if the data substantiate the need.
These final rules on fortification will be published in the Federal Register and will become effective Jan. 1, 1998.