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Carbonyl iron pediatric poisoning label warning unwarranted -- Rexall Sundown petition.

This article was originally published in The Tan Sheet

Executive Summary

CARBONYL IRON LABEL WARNING EXEMPTION URGED BY REXALL SUNDOWN in recent comments to FDA submitted on behalf of the dietary supplement manufacturer by the D.C. law firm of Hyman, Phelps & McNamara. The petition responds to a Jan. 15 final rule that temporarily exempts carbonyl iron from unit-dose packaging regs stipulated for elemental iron products, but does not exempt carbonyl iron from a boxed label warning concerning the risk of pediatric poisoning ("The Tan Sheet" Jan. 20, pp. 1-4). Rexall makes and distributes supplements that contain carbonyl iron as the sole source of iron.
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