Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -64

Accepted - Volume 298

Comment Record
Commentor Dr. J Lee Phelps Date/Time 2003-03-06 17:00:59
Organization Arlington Laboratories
Category Company

Comments for FDA General
1. General Comments Ephedrine-containg products are as safe as many other products in the drug and herbal supplement catogories when used in small dose, i.e., 10-15 mg/8 hour period. The problem is that no one can control the number of doses a person will take, or how long a period they will be taken, or what other products may be taken with the ephedrine, or what health problems a person may have prior to taking ephedrine. Label warnings only go so far. A product information sheet that is attached to the product in some way could be more informative. When supplied with the required information, the individual would then make a more informed choice, and accept responsibility for his/her choice.No reasonable person takes 3 to 10 times the recommended dose and then runs for an hour. How many times do you have to tell a person WARNING: misuse may be harmful to your health??? At some point, these folks have to pull their head out and take charge of their own life.

EC -64