1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC113
  



  

  
Submitter : 
  

  
Dr. ROBERT ROSENBERG
  

  
Date & Time: 
  

  
12/07/2006 11:12:13
  



  

  
Organization : 
  

  
ST. JUDE HERITAGE MEDICAL GROUP
  



  

  
Category : 
  

  
Health Professional
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Food and Drug Administration



ATTN: Division of Dockets Management



5630 Fishers Lane, Room 1061, HFA-301



Rockville, MD 20852



re: docket number 1978N-0065, RIN 0910-AF53



Hydroquinone is one of the most effective molecules for the treatment of dark discoloration over the past 40-50 years and has been used in millions of people. It is used to treat the top concerns among our patients including melasma, photo-aging, post-inflammatory hyperpigmentation, medically and cosmetic disfiguring dyschromias. 

Since 1961, hydroquinone has demonstrated a safe and effect profile among clinicians prescribing or recommending hydroquinone products. In spite of humans exposure to natural sources of hydroquinone in wheat, pears, berries, coffee, tea, onions, rice and red wine, there is not an association with carcinogenicity. There have been no reported cases of related malignancies in more than 50 years of manufacture and use of HQ.



To remove this substance from the dermatologist's armamentarium will be deleterious to patient care and will not improve safety.



Thank you very much.



Very truly yours,



Robert M. Rosenberg, M.D.

Chief, Dermatology

St. Jude Heritage Medical Group

Fullerton, California