Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1384

Accepted - Volume 326

Comment Record
Commentor Mr. Ries van Stijn Date/Time 2003-04-05 11:42:30
Organization Wellness WorldWide
Category International

Comments for FDA General
Questions
1. General Comments Docket #95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids. I have used ephedra products for more than four years now and benefited from BioLean. I lost about 10 pounds weight and the size of my costumes changed some inches. Furthermore this product gave me much more energy (As a partner in a big consulting and audit firm I had a burnout) and as a result too my allergies diminished dramatically. I'm much healthier now than I was before. I had never any serious adverse reaction. As a result of my enthousiasm I made much mouth to mouth advertisement. My wife, my (adult) kids and tens of others (friends, relatives, and others) use Biolean now. They are also very enthousistic, have good results and none of them had any serious adverse reaction. The products I am taking are currently undergoing clinical trials at Johns Hopkins University. Also the RAND report confirms the safety of ephedra products. I want strongly support responsible legislation, not a blanket response of banning all ephedra products. Please compare the use of this harmles, natural, product to other products that can be abused or misused, such as (in your country)acetaminophen (15,000 emergency room visits each year), pain relievers (16,000 deaths each year), not to mention alcohol and cigarettes! I assume that in my country with about 15 million people these figures are pro rata parte the same. In your country obesity is already a big problem (27 % of the population, and an increase of 10% within 5 years), but in the Netherlands we have also about 45% people who are overweighted, in the United Kingdom the problem is even bigger than in the USA. How much illness, even deads, bad quality of life, and cost will this cause? Furthermore: The product I have consumed (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 or ephedra/caffeine mix. BioLean has no direct caffeine source (less than 10 mg is present from the Green Tea) and the ephedra accounts for a small fraction of the total formula. The product I consume 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. The product I have consumed has contained warnings far above those required by the FDA (ie: serving limits, restrictions to minors), and has always advised consumers not to take it unless advised by a doctor when certain physical ailments are present.




EC -1384