News
10/05/1994

<TITLE>FDA PROPOSES SAFETY MEASURES TO PREVENT CHILDHOOD IRON POISONING</TITLE>
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                          Press Release

P94-18                             Food and Drug Administration
FOR IMMEDIATE RELEASE              Judith Foulke (202) 205-4146


     The Food and Drug Administration today proposed that
packages of capsules and tablets containing iron be labeled with 
warnings not to leave the packages open or within reach of
children to prevent accidental and potentially fatal poisonings.
     Manufacturers also would be required to put any product with
30 milligrams or more iron per pill or capsule in individual-dose
packaging, such as a blister pack.  Most prenatal iron products
contain 30 mg. or more iron and are likely to be in households
with young children.
     The FDA proposals would apply to prescription products as
well as nonprescription products.
     "These proposals have the potential to eliminate deaths and
injuries from iron poisonings," said FDA Commissioner David A.
Kessler, M.D.  "Everyone who takes care of small children needs
to understand iron can be toxic, and even fatal." 
     Accidental ingestion of iron is the leading cause of
poisoning deaths in children under 6, despite child-resistant
packaging.  Since 1986, over 110,000 incidents of children
ingesting iron have been reported, with 33 deaths and a doubling 
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                         Page 2, P94-18, Childhood Iron Poisoning
of incidents attributable to adult iron-containing products
compared to earlier years.      
     There is no record of children suffering iron toxicity by
getting into liquid or powders, but these products could also be
toxic in large amounts, FDA said.  Therefore, the proposal asks
for public comment on whether these products should also be
covered by the proposed requirements.
     The warning statement, as proposed, would appear in a
conspicuous area on all solid oral dosage products containing
elemental iron or iron salts.  The proposed wording would warn
adults to secure child-resistant closures properly, keep unit-
dose packaged products in original containers, store them out of
the reach of children and seek immediate medical attention if a
child accidentally swallows the product.  
     The warning would also state that an overdose of iron may
cause harm or death to a child.
     FDA plans to test the proposed wording in focus groups to be
certain it is clear.  Most products now carry a milder statement,
such as "Keep out of Reach of Children."
     Since passage of the 1978 Poison Prevention Packaging Act,
the U.S. Consumer Product Safety Commission has required that
iron-containing products with more than 250 mg. of iron per
container be packaged in child-resistant packaging.  But FDA,
CPSC and a consensus of public health officials and industry      
groups have recognized the need for additional safeguards to
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                         Page 3, P94-18, Childhood Iron Poisoning
reduce the incidence of pediatric iron poisonings that occur when
children are left unattended in the presence of uncapped
containers.  Most serious injuries occur with products having
more than 30 mg of iron per dosage unit.  Unit-dose packaging
would be designed to limit a child's access to a harmful number
of tablets or capsules.
     FDA is soliciting comments on several issues addressed in
this proposal -- for example, whether iron containing products
should be reformulated or different coatings used so as to avoid
a resemblance to candy and where warnings should be placed on the
package.  Those wishing to submit written comments should send
them by Dec. 19, 1994, to:  
          Dockets Management Branch, (HFA-305) 
          Food and Drug Administration, Room 1-23 
          12420 Parklawn Drive 
          Rockville, Md.  20857

     FDA is one of eight Public Health Service agencies in HHS.

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