J Pain Palliat Care Pharmacother. 2004;18(3):95-107.
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 wellknown 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 (21CFR Part 119). This report includes the Table of Contents of the full Federal Register publication and selected sections and tables from that publication.
美国食品药品监督管理局发布了一项最终规定，宣布含有麻黄碱生物碱的膳食补充剂根据《联邦食品、药品和化妆品法案》（该法案）属于掺假产品，因为在标签推荐或建议的使用条件下，或者如果标签未建议或推荐使用条件，则在正常使用条件下，它们存在不合理的疾病或伤害风险。该机构采取这一行动是基于麻黄碱生物碱广为人知的药理学、关于麻黄碱生物碱作用的同行评审科学文献以及据报道在食用含有麻黄碱生物碱的膳食补充剂后个体发生的不良事件。最终规则于2004年2月11日发布在《联邦公报》第69卷第28期，第6787 - 6854页。这项于2004年4月12日生效的规则现已纳入《联邦法规汇编》（21 CFR Part 119）。本报告包括完整的《联邦公报》出版物的目录以及该出版物的部分选定章节和表格。
