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The FDA on Ma Huang/Ephedra & Ban Xia/Pinellia

The FDA on Ma Huang/Ephedra & Ban Xia/Pinellia

April 2004

How the Ruling Affects Your Herbs

The FDA ruling against the sale of products containing Ma Huang and Ban Xia (Ephedra and Pinellia) went into effect April 12, 2004. In the words of the FDA: "The rule applies to all dietary supplements that contain a source of ephedrine alkaloids, such as ephedra, ma huang, sida cordifolia and pinellia." Fortunately, traditional Chinese herbal remedies are exempt. Specific guidelines as to what constitutes a traditional Chinese herbal remedy has not been made.

Until more information is available, Mayway is limiting the sale of all Ma Huang and Ban Xia containing products to licensed health care practitioners prescribing to patients under their direct supervision only. Licensed practitioners may continue to purchase the listed products, which will have the following warning label as required by the States of California, Texas, New Jersey, New York, and Florida:

WARNING: NOT FOR USE BY INDIVIDUALS UNDER THE AGE OF 18 YEARS. DO NOT USE IF PREGNANT OR NURSING. Consult a physician or licensed qualified health care professional before using this product if you have, or have a family history of prostate cancer, prostate enlargement, heart disease, low "good" cholesterol (HDL), or if you are using any other dietary supplement, prescription drug, or over-the-counter drug. Do not exceed recommended serving. Exceeding recommended serving may cause serious adverse health effects. Possible side effects include acne, hair loss, hair growth on the face (in women), aggressiveness, irritability, and increased levels of estrogen. Discontinue use and call a physician or licensed qualified health care professional immediately if you experience rapid heartbeat, dizziness, blurred vision, or other similar symptoms. KEEP OUT OF REACH OF CHILDREN.

For more information please visit the FDA website at
www.fda.gov

MA HUANG CONTAINING PRODUCTS

Code #    Product Name
3958    Chui Feng Tou Gu Wan
3385    Ge Gen Wan (Kudzu Teapills)
3312    Ma Huang Tang Teapills
3319    Xiao Qing Long Wan (Minor Blue Dragon Teapills)

BAN XIA CONTAINING PRODUCTS

Code #    Product Name
3335C    Ban Xia Hou Po San Extract Powder
3335    Ban Xia Hou Po Wan (Pinellia & Magnolia Teapills)
3646C    Bao He San Extract Powder
3646    Bao He Wan
3371    Chai Hu Long Gu Mu Li Wan (Bupleurum Dragonbone Oystershell Teapills)
3323    Da Chai Hu Wan (Major Bupleurum Teapills)
3317    Ding Chuan Wan (Clear Mountain Air Teapills)
3670C    Er Chen San Extract Powder
3671    Er Chen Wan
3670    Er Chen Wan
3636    Huo Xiang Zheng Qi Wan
3128    Liu Jun Zi Wan (Six Gentlemen Teapills)
3648    Mu Xiang Shun Qi Wan
3634    Ning Sou Wan (Quiet Cough Teapills)
3746C    Qing Qi Hua Tan San Extract Powder
3745    Qing Qi Hua Tan Wan (Clean Air Teapills)
3746    Qing Qi Hua Tan Wan (Pinellia Root Teapills)
3393C    Wen Dan San Extract Powder
3393    Wen Dan Tang Wan (Rising Courage Teapills)
3351    Wen Jing Tang Wan (Warm Cycle Teapills)
3680C    Xiang Sha Liu Jun Zi San Extract Powder
3680    Xiang Sha Liu Jun Zi Wan
3681    Xiang Sha Liu Jun Zi Wan (Six Gentlemen Plus Teapills)
3642    Xiang Sha Yang Wei Wan
3626    Xiao Chai Hu Tang Wan (Minor Bupleurum Teapills)
3319    Xiao Qing Long Wan (Minor Blue Dragon Teapills)
3356    Xuan Bi Wan