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1994.10.05 :  Childhood Iron Poisoning Prevention

Contact:  Food and Drug Administration
          Judith Foulke (202) 205-4146
Oct. 5, 1994

              FDA PROPOSES SAFETY MEASURES TO PREVENT 
                      CHILDHOOD IRON POISONING

     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 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 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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