Rule to protect children from iron poisoning

FDA Consumer, April, 1997

Efforts to protect children from accidental iron poisoning are getting a boost from a new FDA rule.

Beginning July 15, when the rule will take effect, labels on all drugs and dietary supplements that contain iron or iron salts will have to display prominently and conspicuously this boxed warning:

"WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately."

In addition, products containing 30 milligrams (mg) or more of iron per dosage unit, such as most iron pills for pregnant women, will have to be packaged as individual doses--for example, in blister packages. This is to limit the number of pills or capsules a small child could accidentally consume once the package is opened.

FDA published the final rule in the Jan. 15, 1997, Federal Register.

Accidental overdose of iron pills is a leading cause of poisoning deaths among young children. Since 1986, more than 110,000 incidents of iron ingestion by children have been reported, and 35 children have died.

Under U.S. Consumer Product Safety Commission regulations, most drugs and food supplements with more than 250 mg of iron per container must have child-resistant packaging. However, in some poisoning cases, young children had been left unattended in the presence of uncapped containers. FDA and a consensus of public health officials and industry groups hope that the additional safeguards, together with greater public awareness of the problem, will reduce the incidence and severity of iron poisonings in children.