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ACMA Publication Issue May 1, 2007 ACMA Comments on FDA Guidance for Industry on CAM American Chinese Medicine Association (ACMA)
Dear Food and Drug Administration: Following please find the American Chinese Medicine Association (ACMA)'s comments on the Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration (it will be called "Guidance" below). Since ACMA is a professional organization specialized in Chinese Medicine, following comments will focus on Chinese Medicine mainly. 1. Introduction Since the Guidance is on the "Complementary and Alternative Medicine (CAM)", the entire Guidance can be divided into the following two parts: (A) The first part is related to the issue on "Complementary and Alternative"; (B) The second part is related to the issue on "Medicine". Following comments will focus on these two aspects respectively. 2. Medicine In the past, herbs were classified as dietary supplements rather than medicine in the United States. As a result, the medicinal functions of traditional Chinese Medicine were denied in the United States. The Guidance, for the first time in FDA's history, officially acknowledges that the traditional Chinese Medicine is a medicine rather than dietary supplements. ACMA deems that this is a positive move from the FDA, is a significant progress for traditional Chinese Medicine in the United States, and will undoubtedly benefit millions of American patients and the public. 3. Complementary and Alternative According to the Guidance: "... depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device, or food (including food additives and dietary supplements) under the act or the PHS Act." This statement opens the door for the possible regulation of traditional Chinese Medicine by means of allopathic medicine ways and methods. This, however, is inappropriate and wrong. Generally speaking, the term CAM is a very broad and diversified term encompassing many different types of medicines. Each type of CAM has its own characteristics different from allopathic medicine. Actually, the definition of the term "Complementary and Alternative Medicine" also proves that the CAM is different from the allopathic medicine. The definitions of "Complementary Medicine" and "Alternative Medicine" are as follows:
Above definitions clearly indicate that both "Complementary Medicine" and "Alternative Medicine" are outside of, parallel to, and different from the allopathic medicine. Different medicines should be regulated differently according to their own characteristics. This actually is not unique to medicine. It is common to all other sciences and technologies. For example, in the field of engineering, there are mechanical engineering, electrical engineering, chemical engineering, civil engineering, etc. Different engineering should be regulated differently according to their own characteristics. It would be wrong to regulate one engineering by means of another different engineering's ways and methods. Similarly, it is wrong to regulate one medicine by applying another completely different medicine's ways and methods. Wrong regulations will do more harms than good to both the medicines and the patients and public. The traditional Chinese Medicine is very different from allopathic medicine in many aspects [1]. It takes 6 years of Chinese Medicine medical school study to obtain a Chinese Medicine doctor (CMD) degree [2]. So the allopathic medicine professional is equal to layperson in the field of traditional Chinese Medicine. Therefore, the regulation of traditional Chinese Medicine should follow traditional Chinese Medicine's rules, principles, and methods rather than by following the allopathic medicine's ways and methods. Applying the allopathic medicine's ways and methods to traditional Chinese Medicine is similar to applying English grammar to Chinese language. It is inappropriate and it will not work. Furthermore, it will harm not only the related medicines, but also patients and the public. In sum, above statement and related sections in the Guidance need to be revised and amended. The new revised version of the Guidance should reflect and ensure that the Complementary and Alternative Medicine's regulations will follow its own characteristics rather than copy the allopathic medicine's regulations. Thank you. References: [1] Xu, B. Mathematical Herbal Medicine. ACMA Publication Issue May 2, 2005.
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