NHA challenges iron unit-dose packaging requirements in law suit against FDA.
This article was originally published in The Tan Sheet
Executive Summary
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.
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