Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -291

Accepted - Volume 298

Comment Record
Commentor Mr. Taylor Ransone Date/Time 2003-03-16 21:04:45
Organization Healthway Nutrition Center
Category Health Professional

Comments for FDA General
1. General Comments When used in accordance with responsible manufacturer's dosage instructions and contraindications ephedra has been well tolerated by our customers. While the majority have been interested in weight loss others have taken for helping with respiratory conditions. I am concerned that irresponsible companies may use synthetics or higher than necessary amounts, but even more so by the failure of individuals to use common sense like following the directions. We operate under a 100% money back gaurantee system and of the people who bring ephedra or certain other products back we invariably find they exceeded the recommended dosage or consummed alcohol or large amounts of caffienated beverages and didn't eat food that day. I would urge you to also use common sense is deciding how to handle ephedra. Some media, attorneys and politicians would have us believe that ephedra is a truely deadly substance that should be banned. The facts on how deadly it is may be fuzzy but even your own studies show that of the milllions of doses taken every day only a few deaths showed even a strong linkage in the 10 or so years you've tracked. Compared to alcohol, diet, tobacco, pharmaceutical drugs (including aspirin) the risk seems very low. Maybe labeling will help. Maybe doing random checks to verify the actual amounts of indgredients in each product will help. But in the end it all comes down to the consumer following directions (label and seller). Unfortunately many won't - thus we have the Darwin Awards.

EC -291