Iron-Containing Supplement, Drug Unit-Dose Packaging Rule Invalid – Court
This article was originally published in The Tan Sheet
Executive Summary
FDA's reliance on current Good Manufacturing Practice regulations under the FD&C Act to justify requirement of unit-dose packaging for iron-containing dietary supplements and drugs is "misplaced," a New York federal appeals court concludes
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Iron final rule
Blister packs will not be mandatory for iron supplements as of Oct. 17, agency announces in same-day 1Federal Register notice. In January, a three-judge Court of Appeals panel overturned a previous decision supporting FDA's requirement for unit-dose packaging because the agency did not show that "iron-containing supplements may be adulterated without such packaging" (2"The Tan Sheet" Jan. 27, 2003, p. 9). Nutritional Health Alliance first filed suit in August 1997 alleging FDA "did not have the authority...to issue and enforce regulations for the purpose of poison prevention"...
NHA challenges iron unit-dose packaging requirements in law suit against FDA.
NHA CHALLENGES UNIT-DOSE PACKAGING REQUIREMENTS FOR IRON -containing dietary supplements and drugs in a suit filed against FDA Aug. 29 in Manhattan district court. The Nutritional Health Alliance, represented by Bass & Ullman, New York City, claims that FDA exceeded its regulatory authority by issuing the regs. The final rule, published in the Jan. 15 Federal Register, requires unit-dose packaging and label warnings for all solid oral dosage form dietary supplements and drug products containing 30 mg or more iron ("The Tan Sheet" Jan. 20, pp. 1-4). FDA must file a response to NHA's complaint by Oct. 31.