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

BAN XIA CONTAINING PRODUCTS