Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -313

Accepted - Volume 307

Comment Record
Commentor Dr. Renjing Tu Date/Time 2003-03-17 19:13:06
Organization Shehzhen Qianrenren Sci. & Tech. Development Co.,
Category Company

Comments for FDA General
Questions
1. General Comments I am Renjing Tu from Shenzhen, China. I am executive director of Shenzhen Qianrenren Sci. & Tech. Development Co., Ltd. focusing on botanical based drug development. Recently FDAs news release on HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra has been passed to me. In respond to HHS and FDAs action on seeking rapid public comment on whether the currently available evidence and medical literature present a significant or unreasonable risk of illness or injury from dietary supplements containing ephedra, I offer my opinion particularly on the RAND report as it is the main basis for HHSs action. 1. Synthesized ephedrine. According to the FDA news release, ephedra is a naturally occurring substance derived from the Chinese herbal Ma Huang. Its principal active ingredient is ephedrine, which when chemically synthesized is currently regulated as a drug. The RAND meta-analysis just searched for controlled trials of ephedrine or ephedra that assessed either weight loss or athletic performance in humans. It appears to me that the drug ephedrine was included in the meta-analysis. As synthesized ephedrine is currently regulated as drug by FDA, the problem associated with synthesized ephedrine could be regarded as drug off label use and overdose and may be implied as a need for modification of current drug regulation system. 2. Safety assessment on the clinical trials. As generally all important adverse events or side effects in each intervention group will be carefully monitored and reported in clinical trials, I think the side effects reported in the intervention groups of the no placebo controlled trials should also be pooled in the meta study. Besides, because of the same reason, the sample sizes of both placebo and intervention groups should be the number of all the patients in each group of all 52 trials. For example, 1706 patients could be the sample size for the treatment group for each adverse event. It will be interesting to see what the picture of the adverse events looks like after the adjustment. Based on the above mention reasons, I think it is too early to take any action to the dietary supplements containing ephedra primarily based on the RAND meta analysis particularly adulterated with data of synthesized drug ephedrine which is irrelevant to the dietary supplement. I suggest the RAND meta analysis need to be re-analyzed.




EC -313