title: Status of certain additional over-the-counter drug category II and III active ingredients. Final rule.
abstract: The Food and Drug Administration (FDA) is issuing a final rule stating that the stimulant laxative ingredients aloe (including aloe extract and aloe flower extract) and cascara sagrada (including casanthranol, cascara fluidextract aromatic, cascara sagrada bark, cascara sagrada extract, and cascara sagrada fluidextract) in over-the- counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. This final rule is part of FDA's ongoing OTC drug product review.
mesh_terms: D000504:Aloe / Q000145:classification*; D002400:Cathartics / Q000145:classification; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000145:classification / Q000331:legislation & jurisprudence; D006801:Humans; D004366:Nonprescription Drugs / Q000145:classification*; D031955:Rhamnus / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D002400:Cathartics; D004366:Nonprescription Drugs