Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1146

Accepted - Volume 326

Comment Record
Commentor Dr. Gene Bruno Date/Time 2003-04-01 10:49:54
Organization American Association of Oriental Medicine
Category Association

Comments for FDA General
Questions
1. General Comments Dr. Gene C. Bruno, L.Ac., OMD, President, The American Association of Oriental Medicine, submits the following comments. The AAOM represents practitioners of Oriental medicine in the United States. In supplementary information accompanying the FDA's notice of reopening the comment period on the proposed rule entitled Dietary Supplements Containing Ephedrine Alkaloids, you state that the FDA intends to consider whether in light of current information FDA should determine that dietary supplements containing ephedrine alkaloids present a 'significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.' The U.S. Department of Health and Human Services commissioned RAND corporation to analyze and assess the existing literature on ephedra based supplements. RAND concluded that neither the clinical trials nor the case reports examined by RAND prove a causal relationship between ephedra and the adverse events described in these documents. The RAND study, the most recent and comprehensive analysis of the evidence, provides no basis for a determination that dietary supplements containing ephedra are unsafe under ordinary conditions of use. As the RAND study points out, ephedra has been used in Chinese medicine to treat respiratory conditions for thousands of years. None of the adverse events discussed in the report involve the use of ephedra in Chinese herbal formulas under Chinese medicine treatment protocols. There are good reasons for that. First, the RAND study is primarily directed at the use of ephedra for weight loss or athletic performance enhancement. Chinese medicine does not use ephedra for these purposes. Second, the dosage levels in Chinese herbal formulas are significantly lower than those in the supplements discussed in the RAND study. Finally, the duration of use for these formulas is generally short term. Consequently, there is no evidentiary basis for determining that the use of ephedra in Chinese herbal formulas is unsafe under ordinary conditions of use in Chinese medicine. Our concern is that any regulation of ephedra not be overbroad. We are worried that any regulations will be universal in scope. We think any regulations or determinations by FDA should be narrowly focused, addressing the particular uses addressed in the RAND study, weight loss and athletic performance enhancement. The centuries of benign and beneficial use of ephedra by Chinese medicine practitioners should be recognized and taken into account. In any regulation, appropriate exception should be taken for the use of Chinese herbal formulas by Oriental medicine practitioners. We oppose any amendment of 21 USC 342(f). We believe in the safety of our herbal formulas. They have stood the test of time. Certainly, any herb or herbal formula which is proven unsafe should be withdrawn from the market. We also believe the burden and cost of proving that a particular herb is unsafe should remain on the Government.




EC -1146