EMEA wants ethanol limited in herbal meds
This article was originally published in The Tan Sheet
Executive Summary
Manufacturers should limit ethanol content in pediatric herbal medicines so that blood ethanol concentrations do not exceed 0.125 g/L after a single dose, the European Medicines Agency's Committee on Herbal Medicinal Products recommends in a Nov. 6 reflection paper. EMEA says safety thresholds for ethanol exposure to children by oral herbal products are necessary because "even small amounts of ethanol" could harm children's psychomotor development, among other risks. The committee also recommends products with more than 30 grams of ethanol be packaged in childproof containers. Comments on the recommendations are due March 15