Regulacje i polityka gospodarcza · 6.10.1994

Iron-Containing Supplements and Drugs; Label Warning Statements and Unit-Dose Packaging Requirements; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES

The Food and Drug Administration (FDA) is proposing regulations to require label warning statements for products taken in solid oral dosage form to supplement the dietary intake of iron or to provide iron for therapeutic purposes. FDA is also proposing regulations to require unit-dose packaging\1\ for iron-containing products that contain 30 milligrams (mg) or more of iron per dosage unit.\2\ FDA is proposing these regulations because of the acute iron poisonings, including deaths in children less than 6 years of age, attributable to accidental overdoses of iron-containing products. The intent of these proposed regulations is to reduce the risk of accidental iron poisonings of young children by utilizing FDA's authority in conjunction with the existing requirements of the U.S. Consumer Product Safety Commission (CPSC) for child-resistant packaging for household substances. This proposal responds to three citizen petitions (Docket Nos. 91P-0186/CP1, 93P-0306/CP1, and 93-0306/CP2) that requested that FDA take action to ensure that products containing iron or iron salts do not pose a health hazard to young children and infants.