This is an archive page. The links are no longer being updated.

Date: Wednesday, January 15, 1997
FOR IMMEDIATE RELEASE
Contact: Food and Drug Administration, Judith Foulke (202) 205-4144
Broadcast Media(301) 827-3434, Consumer Hotline  (800) 532-4440

Warnings Required on Iron-Containing Drugs and Supplements

FDA today announced rules to protect children from accidental poisoning from iron-containing drugs and dietary supplements. These products must now bear a label warning statement, and in addition, products containing 30 milligrams or more iron per unit must be packaged as individual doses that will limit the number of pills or capsules a small child could readily consume.

Accidental overdose of iron is a leading cause of poisoning deaths in children under six, despite child-resistant packaging. Since 1986, more than 110,000 incidents of children ingesting iron have been reported, and 35 children have died.

"Even one child poisoning is too many, particularly if it can be prevented," said Food and Drugs Commissioner David A. Kessler, M.D. "Parents, care-givers and grandparents the children may visit need to know that iron-containing products can be toxic in large doses, and even fatal, if swallowed by a small child."

Packages of all preparations that contain iron or iron salts for use as dietary iron supplementation or for therapeutic purposes must now display -- in a prominent and conspicuous place set off by surrounding lines -- the following statement:

"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."

Most of the serious injuries have occurred with products having more than 30 mg of iron per dosage unit. This includes most prenatal iron products, which are likely to be found in households with young children. FDA has determined that individual-dose packaging, such as a blister pack, would limit the number of capsules or tablets a child could consume if he or she accidentally gained access to such products.

In 1978, the U.S. Consumer Product Safety Commission (CPSC) adopted regulations requiring iron-containing products with more than 250 mg of total iron per container be packaged in child-resistant containers. 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 pediatric iron poisonings.

Note: HHS press releases are available on the World Wide Web at: www.hhs.gov.