# Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients
> **Food and Drug Administration** · Final rule. · Published 2002-05-09 · Effective 2002-11-05 · 67 FR 31125
## Document
- **Document number:** 02-11510
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 67 FR 31125
- **CFR reference:** 21 CFR 310
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2002/05/09/02-11510/status-of-certain-additional-over-the-counter-drug-category-ii-and-iii-active-ingredients)
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