Cascara Sagrada, Aloe Laxatives, O-9 Contraceptive Are Category II – FDA
This article was originally published in The Tan Sheet
Executive Summary
Reformulation of all cascara sagrada- and aloe-containing laxatives with approved active ingredients could cost industry up to $17.8 mil., including an estimated relabeling cost of $612,000, FDA states
You may also be interested in...
Aloe Definition Clarification In Laxatives Final Rule Requested By AHPA, IASC
FDA's final rule on aloe and cascara sagrada does not properly distinguish between aloe used in OTC drug laxatives and aloe vera gel used in foods and dietary supplements, AHPA and the International Aloe Science Council say in a 1citizen petition
Nonoxynol-9 Labeling Changes Under Discussion At FDA
Modifications of nonoxynol-9 (N-9) labeling are being considered by FDA, but the spermicide's OTC status appears to be safe for the time being
Bisacodyl, senna OTC laxative safety data requested by June 1999 in FDA proposal.
BISACODYL, SENNA OTC LAXATIVE SAFETY DATA REQUESTED BY JUNE 1999 in an FDA proposed rule published in the June 19 Federal Register. As expected, the proposal tentatively reclassifies senna, bisacodyl, cascara sagrada and aloe from Category I (safe and effective) to Category III (further testing needed) in the tentative final monograph for OTC laxatives and reopens the administrative record for data considered necessary to establish the safety of the ingredients.