2004N-0454 - Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC3
  



  

  

  



  

  
Submitter : 
  

  
Dr. Thomas Wnorowski
  

  
Date & Time: 
  

  
11/09/2004 04:11:56
  



  

  
Organization : 
  

  
Dr. Thomas Wnorowski
  



  

  
Health Professional
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Before restrictions are made on the availability of dietary supplements, ardent consumer education is warranted.  Overzealous users of supplements sometimes fall prey to the 'more is better' syndrome, and inadvertently suffer uncomfortable consequences.  



Most of the common supplements available are supported by serious science: double-blind, placebo-controlled, randomized studies that have been performed in vitro and in vivo on animal and human subjects.



Ephedra, for example, had been used in Traditional Chinese Medicine for a thousand years or more without incident.  It was the misuse and misapplication of the product that led to problems.  Ephedrine, an active ingredient in OTC medications, has similar physiological effects, but has not yet been deemed a toxin.



There are thousands of research papers outlining the efficacy and safety of most dietary supplements.  Were someone to compile the documents, it would become evident that  restricting the sale of supplements may not be warranted.



Most popular supplements are complements to allopathic medicine, not replacements for it.  Some pharmaceutical companies also make these supplements, therein applying the best of their science.  If anything should be done to address the supplement industry, it should entail compliance with good manufacturing practices and standardization of product.