NEWS
10/08/1993

<TITLE>FDA Proposes that Folic Adic be added to Flour, Breads, and oher Grain Products</TITLE>
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P93-38                            Food and Drug Administration    
FOR IMMEDIATE RELEASE             Brad Stone (202) 205-4144
                                
     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.
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                                     Page 2, P93-38, Folic Acid
     "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 before 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 
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                                  Page 3, P93-38, Folic Acid
consumption of the vitamin by women of 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
B-12 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 tube 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.
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