Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -536

Accepted - Volume 307

Comment Record
Commentor Dr. Philip Gilly, MD Date/Time 2003-03-22 17:19:53
Organization Hudson Wellness Center
Category Health Professional

Comments for FDA General
1. General Comments Dear Sirs: I have been a Family Physician in outpatient practice since 1985. I do NOT feel that there are reasons for heightened concern that ephedra may present a significant and unreasonable risk of illness and injury. I agree that there should be strong statements cautioning about the OVERUSE of ephedra-containing products, especially under conditions of strenuous exercise and in combination with other stimulants, including caffeine. In my clinical experience with patients and myself using ephedra, I have not encountered any adverse effects or reactions when used as directed. I feel that most adverse effects result from inadvisable or intemperate use. I think that it is important to emphasize to the public that Ephedrine has long been available in some FDA-approved over-the-counter and prescription drugs. It appears that the more controlled availability of synthetic ephedrine products, which are available primarily for approved uses for respiratory symptoms and carry mandatory warning labels, has not been associated with the same kind of severe adverse events as have occurred with dietary supplements containing ephedra. This long experience with synthetic ephedrine (in over-the-counter drug products, not in dietary supplements) suggests that similar restrictions on labeling, marketing, and/or access to ephedra might effectively address unreasonable risk-taking associated with certain forms of ephedra today. I would support the FDA categorizing ephedra as an OTC medication rather than an unregulated dietary supplement. Most importantly, I ask that you do this in such a way that reinforces the benefits and safety of ephedra when used in prescribed amounts, as it represents a very useful tool for physicians to use in treating OBESITY, the number one health epidemic in this country. Thanking you for your kind consideration, I remain, Respectfully yours, Philip A. Gilly, MD, FAAFP

EC -536