Fed Regist. 2004 Feb 11;69(28):6787-854.
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.
美国食品药品监督管理局（FDA，我们，我们的）正在发布一项最终规定，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。我们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，以及据报告在食用含有麻黄碱生物碱的膳食补充剂后个体中发生的不良事件。
