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NDMA requests carbonyl iron exemption from FDA proposal based on adverse event data.

This article was originally published in The Tan Sheet

Executive Summary

CARBONYL IRON ADVERSE EVENT DATA FROM NDMA MEMBERS supports the exemption of carbonyl iron-containing products from FDA's proposal to require unit-dose packaging and warning labels on products containing over 30 mg iron, the Nonprescription Drug Manufacturers Association maintained in a May 22 letter to FDA. NDMA polled its member companies that make carbonyl iron-containing products about reported adverse events and found that "most reported cases had a minor effect or no effect at all."
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