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This article was originally published in The Tan Sheet

Executive Summary

IRON SUPPLEMENT LABEL BOXED WARNING REQUESTED BY 34 ATTORNEYS GENERAL for supplements containing 30 mg or more of elemental iron per tablet or capsule. In an Aug. 16 petition to FDA, the 34 state AGs urged the agency to promulgate a regulation that requires iron supplement labels to "contain a conspicuous boxed warning that states: Warning: Keep away from children. Contains iron which can be harmful or fatal if swallowed by a child." The warning, the petition asserts, should "be in boldface type and must be in a color that contrasts with the background and with other printed material on the label and labeling." The AGs also recommended that overdose information should appear "immediately following" the boxed warning on the label. The petition suggests as a potential overdose statement: "Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death." On the labels of iron supplements containing less than 30 mg of elemental iron per tablet or capsule, the state attorneys general requested that FDA require the same "conspicuous boxed warning." However, an accompanying overdose statement was not recommended by the AGs for supplements with less than 30 mg elemental iron. The AGs also suggested that iron supplements containing over 30 mg iron be "packaged in child-resistant individual blister packs," and that FDA prohibit "the manufacture and sale of adult formulations of iron supplements that look like candy and/or contain a sweet outer coating." The petition notes that such supplements "are extremely attractive to children and, because of their candy-like appearance and sweet outercoating, are likely to be swallowed in large quantities." The petition explains that "while most people regard iron supplements as non-toxic household products and, therefore, are likely to keep them within easy reach of children or not properly secured, iron supplements present a severe hazard to young children who swallow them; they risk severe gastrointestinal and liver damage, shock, coma, cardiovascular collapse and death." The number of iron supplement pills that can cause toxicity in a small child (about 22 pounds), the AGs estimated, ranges "from approximately three to 30." The AGs calculated that "five to 60" pills "can cause the death of such a child." The petition maintains that such amounts "are easy for young children to ingest" due to "the pills' attractive appearance and sweet outer- coating." Based on data from the American Association of Poison Control Centers, the petition notes that 1,247 of "all reported iron supplement ingestions resulted in symptoms that, while not life- threatening, usually required some form of treatment" and that 128 of all reported ingestions of iron supplements "had outcomes that were life-threatening or resulted in permanent injury." In addition, from 1986 to the present, over 40 children under six years of age died as a result of ingesting iron supplements, the petition points out. Citing the poison control center data and the "inadequacy of current warnings and child-resistant caps," the AGs asserted that more rigorous warnings and safety caps are warranted. The petition asserts that "current labeling of most iron supplements fails to adequately warn consumers that these products present a hazard to children who ingest them. Most packages contain no specific warning regarding the toxicity of iron." While labeling on a few multivitamin products that contain iron bears the statement that iron can be harmful in large doses, the petition says, "most iron supplements bear only the non-specific phrase, 'keep out of reach of children.'" Few iron supplement packages "contain the word 'warning' or 'caution'" to "alert the user to the dangers of iron overdose." The petition points out that "the meager statements that do exist are, for the most part, printed in the same color and type size as other material on the label and therefore fail to catch anyone's attention." In addition, the child-resistant closures (CRCs) typically found on iron supplements have failed to prevent iron-related overdoses and deaths among children, the petition complains. "In a recent cluster of five iron supplement poisoning deaths in Los Angeles County occurring in a seven-month period," the AGs observed, "the pills were sold in CRCs in at least four of the cases." As a result of the five iron supplement-related deaths, the Public Health Service in February issued a warning to parents to keep iron supplements out of the reach of children ("The Tan Sheet" March 1, In Brief). Also in February, the Consumer Product Safety Commission issued a consumer product safety alert on iron supplements that urged the use of child-resistant packaging and that the products be kept away from children. The petition was submitted by New York Attorney General Robert Abrams on behalf of AGs from 33 other states. At a July congressional hearing, New York State Assistant AG Shirley Stark expressed dismay that iron supplements do not carry warnings about the dangers of overdose, and noted that New York is "currently addressing the problem" ("The Tan Sheet" July 26, p. 11). As part of the New York AG's iron supplement probe, Stark's office met with industry groups including the Council for Responsible Nutrition. In related endeavors, CPSC expects to hold a meeting on iron supplement safety concerns in September, and the Nonprescription Drug Manufacturers Association is in the process of devising a public education program on iron supplements.

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