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1993.10.08 :  Folic Acid Fortification of Certain Foods

Brad Stone (202) 205-4144
Oct. 8, 1993   

The Food and Drug Administration today proposed that folic acid, a
B-vitamin, be added to flour, breads and other grain products to
lower the risk of neural tube birth defects.  FDA is also proposing
to allow a health claim noting this beneficial effect on the labels
of foods and dietary supplements that are good sources of this
vitamin.

Intake by women of 0.4 milligrams daily of folic acid was
recommended by the U.S. Public Health Service last year for all
women of child-bearing age as a means of reducing spina bifida and
anencephaly in their babies.  Since that time, FDA has worked with
other elements of the Public Health Service and with leading
outside experts to develop the most effective measures for
implementing this recommendation.

About 2,500 live-birth cases of spina bifida and anencephaly occur
each year in the United States.

Several methods can be used to help ensure an adequate intake of
folic acid.  These include consumption of the folate that occurs
naturally in some foods, like citrus fruits and dark green leafy
vegetables, as well as through consuming foods fortified with folic
acid or dietary supplements containing folic acid.  The amount of
folic acid the body derives from all sources is known as total
folate consumption.

"Women of child-bearing age may reduce the risk of neural tube
birth defects by increased folate intake," said FDA Commissioner
David A. Kessler, M.D. "This proposal is designed to provide for
that increased folate intake while avoiding problems that can
result from overconsumption.  This is an important balance to
strike."

The head of the Public Health Service, assistant secretary for
health, Philip R. Lee, M.D., said, "These problems develop before
most women are aware they're pregnant.  That's why young women must
get adequate folate becoming pregnant to reduce their babies' risk
for these serious birth defects."

in spina bifida, the backbone does not fully form around the nerves
of the spinal cord.  The spinal cord is exposed and may be damaged
when the child is born, sometimes resulting in paralysis.  Infants
and children with spina bifida may require a series of operations
and other treatments.  Most grow to adulthood with varying degrees
of disability.

In anencephaly, the child is born with a severe malformation of its
brain and cannot survive.

Today's proposal would require manufacturers to add folic acid to
enriched flours, breads, rolls, buns, corn grits, corn meal,
farina, rice, macaroni and noodle products. it would also allow the
labels of foods that are good sources of folate, and dietary
supplements containing folic acid, to state that daily  consumption
of the vitamin by women or child-bearing age may reduce the risk of
neural tube birth defects in their offspring.

Overconsumption of folic acid can mask symptoms of a vitamin 5-22
deficiency such as-pernicious anemia that, untreated, can lead to
nerve damage.  The fortification levels are designed to stay within
safe levels even for heavy consumers of grain products.

The proposal would allow the addition of folic acid only to a
limited range of products to establish a safe level of intake.  It
also proposes new standards of identity for enriched grain products
that would stipulate the amount of folic acid they must contain.
FDA's sample health claim for these foods would read:

"Daily consumption of 0.4 milligrams (mg) of folate by women of
child-bearing age may be a factor in helping to reduce the risk of
neural tubs defects in their offspring.  Sources of folate include
leafy dark green vegetables, citrus fruits and juices, yeast,
fortified breads and breakfast cereals, beans and dietary
supplements containing folic acid.  Regular daily consumption of
folate should not exceed 1.0 milligram from all sources."

FDA plans to hold a meeting of its Food Advisory Committee,
including its Folic Acid Subcommittee, on Oct. 14 and 15, to
provide a forum for the discussion of these proposals, which were
developed with the cooperation of experts in other agencies.

Comments on the proposed regulations may be sent, within 60 days,
to: Dockets Management Branch, HFA-305, FDA, Room 1-23, 12420
Parklawn Drive, Rockville, Md. 20857.

FDA is an agency of the Public Health Service within HHS.