Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients
other · Food and Drug Administration · Rule · Published 2002-05-09 · Effective 2002-11-05 · 67 FR 31125
Document
Document number
02-11510
Federal Register citation
67 FR 31125
CFR reference
21 CFR 310
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2002-05-09
Effective date
2002-11-05
HHS docket
Docket No. 78N-036L
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.