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CDER seminar

This article was originally published in The Tan Sheet

Executive Summary

Long-term clinical research on traditional Chinese medicine (TCM) is needed to support efficacy of the herbs involved, according to Food & Drug Scientist Richard Ko, PhD, California Department of Health Services. Speaking during a CDER seminar Jan. 29, Ko stated "many of the clinical trials nowadays are too short," noting therapeutic benefits of TCM often "take months to years" to surface. In addition, herbal toxicity resulting from use of TCM, although it poses a "minimal" threat to public health, can be "pretty serious" when it does occur, Ko said. "We need to do a lot more to make sure that all the products that are sold out there are safe," he added, which includes "not only having GMPs, but also [good agricultural practices] as well as better education and better licensing for practitioners." Ko noted many herbs pose safety threats in the U.S. because they are not processed using traditional Chinese methods, which often leads to contamination...

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