From: JCMBFLA@aol.com
Sent: Monday, April 07, 2003 5:51 PM
To: fdadockets@oc.fda.gov
Subject: (no subject)

April 7, 2003
Docket 95N-0304-Dietary Supplements Containing Ephedra

I am a board certified medical toxicologist with a strong interest in the 
toxicity of herbal and nutritional supplements and over the counter products. 
 I have worked as an expert witness in litigation cases however all of these 
opinions and conclusions expressed herein are my own, based on my review of 
the literature and my training as a toxicologist.

In the course of my work as a toxicologist with the Florida Poison 
Center-Miami as well as an expert for Metabolife, I have reviewed hundreds of 
Ephedra case reports and ADRs.  Almost all are poorly documented and rely 
solely on the patients' history.  Even published case reports in peer 
reviewed journals do not substantiate patient's history with blood levels of 
ephedrine or rule out concomitant drug ingestions.  

Billions of servings of nutritional supplements containing Ephedra are sold 
annually.  This strongly suggests millions of Americans are consuming these 
supplements.   Published epidemiologic studies confirm this consumption.   
Despite this overwhelming usage the numbers of adverse events reported to 
Poison Control Centers remain in the hundreds with the majority of cases 
treated at home.  In American Association of Poison Control Centers data 
ephedra has proportionally fewer adverse reactions than ibuprofen or 
acetaminophen.

It would be foolish to suggest that all ephedra containing products are 
without risk.  Many of the adverse events reported are from people who take 
much greater amounts than recommended or when contraindicated.  Printed 
warnings could prevent people from taking ephedra products thoughtlessly.  
Not infrequently consumers take a higher than recommended amount of a 
supplement or over the counter in order to increase efficacy.  This appears 
to be particularly true for ephedra containing appetite suppressants and 
performance enhancers without proper warnings.  

It is also unconsciable for unscrupulous companies to market ephedra 
containing supplements with false and misleading claims.  This practice needs 
to end.

Prospective studies with strict scientific criteria need to be funded.   
Cases must confirm the amount of ephedra present, as well as the presence or 
absence of other compounds and other confounding variables, as well as a 
temporal relationship before complications are attributed to ephedra

Presently there is not conclusive evidence that ephedra products cause 
significant risk when taken under conditions of use suggested in the proposed 
warning.   I encourage safety labeling and appeal for further research.   
Again I applaud the FDA for attempting to better inform and protect the 
public.  



John J Cienki, M.D., FACEP
Associate Professor of Medicine 
University of Miami
Associate Medical Director of Clinical Research
Jackson Memorial Hospital