HHS NEWS

P96-3                               Food and Drug Administration

FOR IMMEDIATE RELEASE               Judith Foulke (202) 205-4144

Feb. 29, 1996



FOLIC ACID TO FORTIFY U.S. FOOD PRODUCTS TO PREVENT BIRTH DEFECTS



     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.

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