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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.

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