Pharmanex revising goldenseal, evening primrose oil, cranberry label claims.
This article was originally published in The Tan Sheet
Executive Summary
PHARMANEX REVISIONS TO GOLDENSEAL, EVENING PRIMROSE OIL, CRANBERRY CLAIMS are designed to bring them into compliance with FDA policies on structure/function claims. The Simi Valley, Calif.-based company informed the agency July 1 it will modify claims for three of its recently introduced herbal products in response to a June 8 "courtesy" letter from FDA. Existing claims for the products "suggest...they are intended to treat or prevent disease caused by pathogenic microorganisms, or to treat, prevent, or mitigate signs or symptoms of premenstrual syndrome," the agency letter states.
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