EU leaves phenolphthalein action decision to individual member states.
This article was originally published in The Tan Sheet
Executive Summary
EU PHENOLPHTHALEIN WITHDRAWAL DECISION LEFT TO INDIVIDUAL MEMBER STATES in a position paper on the genotoxic and carcinogenic potential of phenolphthalein recently issued by the European Medicines Evaluation Agency's Committee for Proprietary Medicinal Products. The position paper reviews FDA's interpretation of National Toxicology Program data on phenolphthalein, advising that the CPMP report "can be used by National Competent Authorities in their considerations of any restriction of availability of phenolphthalein-containing medicinal products on national markets."