1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC555
  



  

  
Submitter : 
  

  
Dr. Michelle  Lee
  

  
Date & Time: 
  

  
01/03/2007 08:01:41
  



  

  
Organization : 
  

  
Michelle H. Lee, M.D., Prof. Corp
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 To the FDA:  As a member of the American Society of Dermatologic Surgery(ASDS), I oppose the FDA's proposed rule change for the following reasons:  hydroquinone is used to treat dyschromia, a condition with significant morbidity, which affects millions of Americans, many of whom are in minority groups.  Requiring a new drug application of hydroquinone would be punitive to dyschromia patients and potentially inequitable to people of various minority groups. The association of cancer in humans is unproven and existing animal data do not support removal of these products from the market.    



Regards,

Michelle H. Lee, M.D.