Zdrowie i gospodarka · 16.02.1995
Iron-Containing Supplements and Drugs; Label Warning Statements and Unit-Dose Packaging Requirements
The Food and Drug Administration (FDA) is issuing a supplemental proposed rule to set forth its legal authority, after the passage of the Dietary Supplement Health and Education Act (DSHEA), to require unit-dose packaging of iron-containing dietary supplements that contain 30 milligrams (mg) or more iron per dosage unit. On October 6, 1994, the agency proposed this packaging requirement as part of a broader proposal to require unit-dose packaging of all iron-containing products in solid oral dosage form containing 30 mg or more iron per dosage unit and to require label warning statements on all iron- containing products in solid oral dosage form. The agency's authority to establish the labeling requirements and the packaging requirements for iron-containing products other than dietary supplements (i.e., iron-containing drugs) is unaffected by the DSHEA. To ensure that there is adequate time to comment on this supplemental proposed rule, as well as on the issues raised by the initial proposal, FDA is reopening the comment period for this rulemaking until April 17, 1995.