Perhaps the most significant event related to acupuncture in the US may be a choice by the FDA in March 1996 to reassess the legal position of acupuncture. The FDA is the most important regulatory body for health products in the United States. Before 1996, FDA set acupuncture needles as Class III. Class I is for medical devices believed to be safe and effective. Class II is for medical products which are safe and effective but require conditions indicated on specific labelling. Class III is for health products which are under investigation. Being Class III, acupuncture can only be performed in research locations, such as laboratory, and there was a ban on specific therapeutic claims. Although this FDA law was not strictly enforced it set significant limit on medical insurance corporations from funding acupuncture practice in the US.
In an attempt to resolve this problem, the National Institute of Health Office of Alternative Medicine spent over one million dollars to organize a workshop on acupuncture in 1994. The convention invited thirteen acupuncture researchers from around the world to present publications to 22 most important FDA executives who were free to critique the presentations. Presenters provided evidence from scientific studies in five major areas: pain, drug dependence, stroke, asthma and nausea. Safety data were also presented suggesting that in proper hand acupuncture was very safe. The speakers provided basic scientific data that clarifies a number of the acupuncture effect. On the whole, The Food and Drug Administration executives were quite impressed by the large amount of basic and clinical research data but were concerned about the heterogeneity of the published papers. There were no multi-centred studies like the ones used to test a new medication. The research on antiemesis came closest to the FDA requirement, since all studies on nausea used the same acupuncture point (Pe 6) on one forearm, and compared it with sham acupuncture provided in a non-point on the other forearm. The FDA also had reservation on sham acupuncture that produced effects.
This article is contributed by Britannia Acupuncture Clinic.
Gale Benz is an alternative health commentator and blogger. She has interest in Traditional Chinese Medicine and Acupuncture.
Post new comment
Please Register or Login to post new comment.