From: VIVIAN ZHANG [zhangv@rcn.com] Sent: Wednesday, April 02, 2003 10:52 AM To: fdadockets@oc.fda.gov Subject: Re: public comments on Ma Huang To Whom It May Concern: I’m Vivien Zhang, Licensed Acupuncturist and National Certified Chinese herbalist. I’m the Herbal Pharmacy Manager and faculty at the New England School of Acupuncture (NESA), which is one the best acupuncture schools in the America offering Oriental Medicine program. Along with my written comments, you’ll find the information of NESA, including: NESA catalog, NESA clinic brochure, the list of all of our clinical affiliations and a single sheet outlining NESA's program. When people are giving suggestions and comments regarding regulating dietary supplements containing ephedra, I think a few questions should be clarified before any further regulation are made. 1. What kinds of products containing ephedrine caused most of the adverse reactions? · OTC medications like Primatete or prescription drugs? · Ma Huang used by Traditional Chinese Medicine practitioners in customized formulas? · Ma Huang sold in products for weight control, as well as in products that boost energy levels? These products often contain other stimulants, such as caffeine, which may have synergistic effects and increase the potential for adverse effects. 2. How many cases of adverse reactions occurred while the individual was under care of the professional practitioners? 3. If professional supervision is required for using ephedra containing products, then the qualification of the professional practitioners needs to be further discussed. The Traditional Chinese Medicine practitioners have used Ma Huang for 4,000 years or more. They found that decoction of the dry-land shrub makes an effective treatment for respiratory ailments like asthma. A problem is generated when Traditional Chinese Herbal Medicine is integrated into the Western medical model by people not schooled in Chinese Herbal Medicine. Because of their mild nature, herbs works best when used holistically, in harmony with all physiological functions and processes. The public has a common misunderstanding that if an herb doesn't work in its whole form, it best be taken in a concentrated extract before it will prove effective. There is danger in using herbs such as Ma Huang in highly concentrated extracts to boost energy. There is also a problem in over advertising specific herbs for a designated pathological disease. In Massachusetts, a qualified licensed acupuncturist prescribing Chinese herbs is required to have at least 450 hours Chinese herbal education from a national certified education program. As a licensed acupuncturist and national certified Chinese herbalist, I am aware of Ma Huang’s use in Chinese traditional medicine. It is generally used for the respiratory system, in a combination with other herbs, for a course of treatment. Some of the misleading information of Ma Huang does not corroborate traditional diagnostic systems with the herbal remedy. Many Chinese herbalists are against using Ma Huang (ephedra) as a energy booster or weight loss products The task of selecting the correct herbal remedy is the primary responsibility of the practitioner. Suggestions: 1. The herbs used by Chinese herbal medicine should be regulated differently from other food supplements. 2. Chinese herbalists (in Massachusetts, licensed acupuncturist who have had the minimum number of required hours, been educated for at least 450 hours in Chinese Herbal Medicine from a national certified educational program) are qualified to prescribe products containing Ma Huang. 3. Products containing ephedra(Ma Huang) should not be used without the professional supervision of a trained Traditional Chinese Medicine practitioner. 4. Products containing Ephedra(Ma Huang) should not be for weight control and boost energy levels purpose. Thank you for taking my comments. Please feel free to contact me if you have any questions about my comments. Sincerely Vivien Zhang, Lic.Ac. Dipl.C.H. Herbal Pharmacy Manager Vivien Zhang, Lic.Ac. Dipl.C.H. Herbal Pharmacy Manager New England School of Acupuncture 34 Chestnut Street, Watertown, MA 02472 Tel: (617) 926-4271, ext 202 Email: zhangv@rcn.com