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.
You may also be interested in...
Supplement GMP Warning Letters Make Modest Debut In 2010
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC
In Brief
Combe sells most of its OTC brands
People In Brief
Perrigo promotes in pricing, planning