FDA Regulation of Imported Non-Compliant Chinese Herbal Remedies

Abstract

I've seen the past and it works! So wrote James Reston, a New York Times reporter, after being treated with acupuncture on the occasion of the removal of his appendix in Beijing in the early trade. At that point, arguably, Traditional Chinese Medicine (TCM) entered mainstream American Consciousness. Today in the United States, the use of TCM, of which Chinese herbal medicines are a part, is quite widespread. In spite of this growth, the Food and Drug Administration (FDA) does not have a consistent policy of regulating Chinese herbal medicines. The purpose of this paper is to investigate why a policy of regulating Chinese herbal medicines is lacking, and to suggest some possible solutions to the dilemma. To achieve this goal, the paper will be divided into three parts. Part one will briefly examine the history of Chinese herbal medicines, and will specifically define the type of herbal medicines that are the focus of this paper. This part will also contain a description of some of the problems that may arise when some Chinese herbal medicines are ingested, as well as a description of the degree to which alternative medical practices, including herbal remedies have permeated American society. The landscape having been set, in part two I will examine the FDA's response to the issues raised by unregulated non-compliant Chinese herbal medicines. Finally, in part three, I shall present some suggestions for the best approach to the regulation of these remedies.