Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1227

Accepted - Volume 326

Comment Record
Commentor Mr. Mario Van den Hoorn Date/Time 2003-04-02 16:52:45
Organization VDH-ManagementGroep
Category Consumer Group

Comments for FDA General
Questions
1. General Comments L.S., I do not understand that an institute like FDA proposes a rule based on misinformation and speculation in the media in stead of serious and fundamental research. As you SHOULD KNOW this products are currently undergoing clinical trials at Johns Hopkins University and the RAND report confirms the safety of ephedra products. I am a user of ephedra products ( BioLean )for several years now, lost weight of 23 kilo's, got energy et cetera AND NEVER HAD A SERIOUS OR ADVERSE REACTION. I advised hundreds of people the ephedraproduct and none of them had serious or adverse reaction. All people lost weight in a natural way. The product I use, Biolean, should not be confused with the multitude of diet or energy products that have been on the market. Many of these controversial products have contained somewhere between 75% to 95% ephedra/caffeine mix. Biolean has no direct caffeine source ( less than 10mg is present from green tea ) and the ephedra accounts for a small fraction of the total formular. The Biolean I use comes in well below the recommended daily amount for ephedra alkaloids, advising a morning dose of 25 mg, followed by an afternoon dose of 12,5 mg. It contains the warnings far above the FDA-required warnings, lie serving limits, restriction to minors and has always advised consumers not to take it unless advised by a doctor when certain physical ailments are present. Furtheron I think it's amazing to see that other products that can be abused or misused, like acetaminophen with about 15,000 emergency room visits and pain relievers with about 16,000 deaths a year, not to speak about alcohol and cigarettes are NOT BANNED at all. So, I DO SUPPORT RESPONSIBLE LEGISLATION, NOT A BLANKET RESPONSE OF BANNING ALL EPHEDRA PRODUCTS. Such an over-reaction I do not expect from FDA. Zwolle, april 2nd The Netherlands Mario van den Hoorn




EC -1227