From: WSheir@aol.com Sent: Thursday, April 03, 2003 6:35 PM To: fdadockets@oc.fda.gov Subject: Ephedra I,-------, support the responsible use of Ephedra. This statement is regarding the use and misuse of the herb Ephedra. The practice of Oriental medicine often includes the use of herbs, and the training in Chinese medicine includes the safe, appropriate and effective use of Ephedra. I oppose the improper or casual use of Ephedra, such as its use for weight loss, and ask all elected officials to ensure appropriate use of this valuable herb. I recommend that Ephedra not be used commercially, but be restricted to professional use, to be dispensed by licensed health care professionals trained in the appropriate use of natural medicine. Ephedra has been used safely and effectively in balanced herbal formulas for thousands of years, to treat such conditions as asthma and the common cold. In Chinese medicine it is not used for weight loss or as a nervous system stimulant, as it has been used in a variety of over-the-counter products. While the hope of easy weight loss is a powerful sales incentive, application of ephedra for this purpose is wholly inappropriate. Like any medicinal agent, whether pharmaceutical or botanical, ephedra is safe and effective when used properly, and unsafe or ineffective when used improperly. The problem here is not the herb, but its inappropriate and misguided use. While banning this herb completely would reduce its casual unguided use, it would also deny its safe and effective use by licensed Chinese medicine health care practitioners to improve the health of their patients in a safe and responsible manner. Such a simplistic, broad-stroke solution does nothing to address the underlying issue: the appropriate use of natural medicine. It also would set a dangerous precedent: the banning of any natural medicine that has the potential to cause harm when used improperly. I call upon the FDA and elected officials to serve citizens by distinguishing between the casual and unguided use of Ephedra in over-the-counter products, and its safe, effective use by fully trained and licensed Chinese healthcare professionals. As interest in Chinese medicine continues to grow in this country, its benefits will extend to many thousands of people seeking natural approaches to healthcare. Please ensure that their treatment choices, and the tools used by their practitioners will be preserved for the future. Thank you for your time and consideration. Sincerely, Warren Sheir L.Ac. M.T.O.M. Professor of Herbal Medicine Pacific College of Oriental Medicine San Diego, CA