Iron-Containing Supplements and Drugs: Label Warning Statements and Unit-Dose Packaging Requirements

The Food and Drug Administration (FDA) is issuing regulations to require label warning statements on products taken in solid oral dosage form to supplement the dietary intake of iron or to provide iron for therapeutic purposes, and unit dose packaging for iron-containing products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA is taking these actions because of the large number of acute iron poisonings, including deaths, in children less than 6 years of age attributable to accidental overdoses of iron-containing products. FDA is temporarily exempting one form of elemental iron, carbonyl iron, from the packaging requirements of this final rule. The temporary exemption will automatically expire 1 year from the effective date of this final rule. If, during the temporary exemption period, FDA receives animal data that establish that carbonyl iron is significantly less toxic than at least one commonly used iron salt, FDA will consider permanently exempting carbonyl iron from the packaging requirements of this final rule.