Senna
This article was originally published in The Tan Sheet
Executive Summary
NDMA asks FDA in a Sept. 17 letter to keep the administrative record open for senna as a Category I laxative ingredient until a proposed two-year carcinogenicity study is completed. Concern regarding the safety of senna prompted FDA to request additional data on the ingredient in a June 19 Federal Register notice ("The Tan Sheet" June 22, p. 6). The deadline for the submission of new data is June 21 next year. NDMA asserts, however, the required studies cannot be finished in a year. "To complete the in-life portion of a long-term rodent study requires at least two years, and that must be preceded by preliminary studies and followed by time-consuming histopathologic examinations and analysis of other endpoints," NDMA points out. The proposed rule also applies to bisacodyl, cascara sagrada and aloe