November 20, 2003
The FDA issued a final ruling on Nov 5, 2002, stating that the stimulant laxative ingredients aloe (including extract and flower extract) and cascara sagrada (including all fluidextracts, bark and casanthranol) in over-the-counter drug products are not generally recognized as safe and effective or are misbranded. The FDA pointed out that there is inadequate data on the toxicity of aloe and cascara sagrada. These products have not been shown to be safe and effective for their intended use. These ingredients should be eliminated from general use within 180 days.