Phytomedicine
Volume 14, Issue 4 , Pages 273-279 , 10 April 2007

Complexities of the herbal nomenclature system in traditional Chinese medicine (TCM): Lessons learned from the misuse of Aristolochia-related species and the importance of the pharmaceutical name during botanical drug product development

  • K.M. Wu

      Affiliations

    • Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    • Corresponding Author InformationCorresponding author.
    • ,
  • J.G. Farrelly

      Affiliations

    • Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA
    • ,
  • R. Upton

      Affiliations

    • American Herbal Pharmacopoeia, Scotts Valley, CA 95067, USA
    • ,
  • J. Chen

      Affiliations

    • Chengdu University of TCM, Chengdu, Sichuan, PR China

References 

  1. CFSAN/US FDA, Office of Nutritional Products, Labeling and Dietary Supplements., 2001. Letter to industry associations regarding safety concerns related to the use of botanical products containing aristolochic acid. http://www.cfsan.fda.gov/~dms/ds-botl4.html
  2. Greuter, W. (Ed.), 2000. International Code of Botanical Nomenclature (St. Louis Code). Koeltz Scientific Books, Königstein (International Association for Plant Taxonomy).
  3. Jiangsu New Medicine College (Ed.), 1995. A Grand Dictionary of Chinese Medicinal Herbs, third ed. Shanghai Science Technology Publishing Co., Shanghai, p. 2754.
  4. SFDA/China, 2003. Suspension of Traditional Chinese Medicine Standard on Guan Mutong. China State Food and Drug Administration 2003, Notice No. 121, April 1 Announcement.
  5. Upton, R., 2004. Unpublished data: American Aristolochic Acid Evaluation Project by American Herbal Pharmacopoeia.
  6. Wu KM, DeGeorge J, Atrakchi A, Barry E, Bigger A, Chen C, et al. A special update from the united states food and drug administration: preclinical issues and status of investigation of botanical drug products in the United States. Toxicol. Lett. 2000;111:199–202
  7. Wu, K.M., 2002. Development of traditional Chinese medicine: use of endangered species and its protection. In: US Fish and Wildlife/Wildlife Conservation Society Symposium on “The Consensus Conference on Protecting Medicinal Plants and Animals in Oriental Medicine”, New York.
  8. Wu KM, Farrelly J, Birncrant D, Chen S, Dou J, Aisar Atrakchi A, et al. Regulatory toxicology perspectives on the development of botanical drug products in the United States. Am. J. Ther. 2004;11:213–217
  9. Wu, K.M., Farrelly, J., 2005. Complexities of the botanical nomenclature system in traditional Chinese medicine (TCM): lesson learned from Aristolochia and importance of the pharmaceutical name. 1:135 (O-19), FDA Science Forum.

☆ A preliminary report of this article has been presented at the FDA Science Forum in Washington, DC, 2005 and Annual Meeting of American Society of Pharmacognosy at Corvallis, Oregon, 2005. This article is not an official FDA guidance or policy statement. No official endorsement by the FDA is intended.

PII: S0944-7113(06)00099-7

doi: 10.1016/j.phymed.2006.05.009

Phytomedicine
Volume 14, Issue 4 , Pages 273-279 , 10 April 2007

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