# Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk
> **Food and Drug Administration** · Final rule. · Published 2004-02-11 · Effective 2004-04-12 · 69 FR 6788
## Document
- **Document number:** 04-2912
- **Category:** fda-food
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 6788
- **CFR reference:** 21 CFR 119
- **Publication date:** 2004-02-11
- **Effective date:** 2004-04-12
- **HHS docket:** Docket No. 1995N-0304
## Abstract

The Food and Drug Administration (FDA, we, our) is issuing a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act (the act) because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use. We are taking this action based upon the well-known pharmacology of ephedrine alkaloids, the peer-reviewed scientific literature on the effects of ephedrine alkaloids, and the adverse events reported to have occurred in individuals following consumption of dietary supplements containing ephedrine alkaloids.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/02/11/04-2912/final-rule-declaring-dietary-supplements-containing-ephedrine-alkaloids-adulterated-because-they)
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