OTC standardized label exemption for small packages may be considered by FDA.
This article was originally published in The Rose Sheet
Executive Summary
STANDARDIZED OTC LABELING SMALL PACKAGE EXEMPTION may be considered by FDA if a bulleted label format is ultimately endorsed by the agency. At an Aug. 17 "OTC feedback" meeting between FDA and industry on OTC label reform, both sides supported a label format that incorporates bullets to make label information more understandable to consumers. However, when industry members maintained that a bulleted format would not be possible on smaller packages such as roll-packs or lip balm containers, FDA Office of OTC Drug Evaluation Director Michael Weintraub, MD, acknowledged that "we may have to exempt small packages from standardized label regulations."