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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