FDA iron supplement packaging rule overturned
the October 17, 2003 requiring manufacturers of dietary supplements
and drug products that contain 30 milligrams or more of iron per
dosage unit to use unit-dose packaging.
The Food and Drug Administration (FDA) has announced that as of October 17, 2003, manufacturers of supplements containing 30 milligrams or more of iron per dosage unit are no longer required by law to use unit-dose packaging.
In a statement on Friday the FDA said it was taking this action in response to the court's ruling in the case brought by Nutritional Health Alliance against the agency, in which the court concluded that the Federal Food, Drug, and Cosmetic Act does not give FDA the authority to require manufacturers of iron-containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes.
'Unit-dose packaging' is when a product is packaged into a non-reusable container designed to hold a single dosage intended for administration directly from that container, irrespective of whether the recommended dose is one or more than one of these units.
In January 1997 the FDA published a final rule that, among other things, required unit-dose packaging for iron-containing dietary supplement and drug products in solid oral dosage form that contain 30 mg or more of iron per dosage unit. These provisions were challenged, however, by the Nutritional Health Alliance (NHA), an association including manufacturers and distributors of iron-containing dietary supplements, on the basis that FDA did not have authority under the act to issue and enforce regulations for the purpose of poison prevention.
The FDA notes that this ruling does not affect the provisions of other rules which require label warning statements on all iron-containing dietary supplements and drugs in solid oral dosage form, except iron-containing inert tablets supplied in monthly packages of oral contraceptives.
The warning label reads: 'Warning: Accidental overdose or iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.'
For further information see the Federal Register or contact Robert J. Moore, from the FDA's Center for Food Safety and Applied Nutrition on 301-436-1441.
