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."
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