Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -365

Accepted - Volume 307

Comment Record
Commentor Mr. Dana Zacuto Date/Time 2003-03-19 19:44:42
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments I have personally been involved in development of dietary supplements. As the founder of Dr. Holper, M.D. bingertabs, I have just learned a new line, what has just come from the president of the United States, SHOCK AND AWE. This industry while fragile must and needs the direction of THE FDA involvement or produce a board from withen the industry to regulate the nesscessary requirements for all AMERICANS SAFTEY, I have personally expereinced a Certified Chinese herboligist that wrote a blend of herbs of which endorphines was a part of. Well as you know endorphines arr manufacture by the human body and not possible for any formulation, when the herbologist was confronted, they said well then take them out of the formula. That was as stupid remark as was placing it in the formula for manufacturing in the first place, while most processing plants are up to FDA specifications, the individuals running them should not be licensed. Many have no clue in many cases of any mixtures and have disclaimer, They dont have the knowelege that they should process in the manufacturing of herbal supplements. This industry could regulate itself, if enough staff would be hired to inspect palnts, formulations. All formulations should be issued a FDA approval for the purpose of reviewing the mixtures these formulators are requiring. The purpose would be, so that the FDA can see if there are any supplments in the mix that might be harmful, this would be a good preventive action In addition, this industry sells herns that are know to cause homopathic remedies, such as likes to cure likes, while using poisons in the human body while in small amounts still poisons to replicate the symptom. I find this needing regulation and all formulas should at least be reviewed by the FDA all products that samples can be submitted to the FDA at this time should be grandfather into regualtion while sustaining the current market and giving companies time to start to prove their claims with voluntary clincal studies of any new formulations. Ephedrine is determined to cause harm and should be banned by all Manufacturing and with the FDA taking the lead. Sincerley Dana Edward Zacuto

EC -365