FDA likely to reduce psyllium maximum daily dose to 14 g in upcoming laxative monograph.
This article was originally published in The Tan Sheet
Executive Summary
PSYLLIUM MAXIMUM DAILY DOSE EXPECTED TO BE REDUCED TO 14 G in the upcoming final monograph for OTC laxative products, according to FDA. In separate July 28 letters to the Nonprescription Drug Manufacturers Association and the U.S. Pharmacopeia, the agency said it plans to reduce the maximum daily dose for psyllium preparations from the 30 g recommended in the tentative final monograph to 14 g. FDA said the decision is based on industry comments as well as a review of the scientific literature and the psyllium-containing OTC laxatives currently on the market.
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