Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Final Rule

Abstract

The Food and Drug Administration issued 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. The agency took 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. The final Rule was published in the Federal Register, Volume 69, Number 28, Pages 6787-6854 on February 11, 2004. This rule that became effective on April 12, 2004 is now included in the Code of Federal Regulations (21 CFR Part 119). This report includes the Table of Contents of the full Federal Register publication and selected sections and tables from that publication.

Key Words:

• Ephedra
• ephedrine
• dietary supplements
• FDA
• rule
• adulteration
• risk
• risk
• benefit
• DSHEA