Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -152

Accepted - Volume 298

Comment Record
Commentor Dr. Ramachandran Nair Date/Time 2003-03-09 00:32:07
Organization Motown Wellness
Category Health Professional

Comments for FDA General
1. General Comments Dear Sirs, I am a medical professional. I am concerned very much with the haste with which some interested parties are trying to ban ephedra. This is purely self-serving to these parties. I have taken ephedra myself, as have my family members and friends. When taken as directed, I have seen NO side effects from the products. It is only when people take these products as they want, disregarding the instructions, that they run into problems. (As was illustrated in the recent tragic demise of the Orioles pitcher). As you may well know, even an enormously beneficial medication like Aspirin with its multitude of benefits to the human body , can when taken in excess cause serious damage!! So is the case with Tylenol!! Even the FDA has suggested that ephedra, if <90 mgm% in any formulation is safe. So it is not in the interest of the numerous safe consumers who use it with no ill-effects in the prescribed manner, to ban this totally; it has produced great results for them. Rather, people should be educated about the safe usage of this supplement. I am all in favour of adequate warning to be given for the safety of the consumer; but products which adhere to the FDA guidelines should NEVEr be banned; rather the industry should be taught to provide clear and adequate warnings or the consumer. Remember, there are always interested parties out there who want this ban, because their products don't work and they want to get rid of this natural substance (which unfortunately, they cannot patent), so that they can fleece the consumer of large sums of money. We have an old saying in my native country - Even Ambrosia, if taken in excess can be poison. I sincerely hope that the FDA will exercise good common sense in arriving at a decision which will not rob the intelligent consumer of a safe and effective product. Thank you, Sincerely, Dr. Ram Nair, MD.

EC -152