1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC154
  



  

  
Submitter : 
  

  
Miss. Sheila Foreman
  

  
Date & Time: 
  

  
12/18/2006 09:12:34
  



  

  
Organization : 
  

  
Miss. Sheila Foreman
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Greetings,  I am writing to the FDA today to urge you not to pursue a change in the status of over-the-counter (OTC) skin bleaching drug products containing hydroquinone to prescription only.



Many of my friends, family and acquaintances rely on the current availability of hydroquinone-based bleaches over-the-counter not only because it's easily accessible but because this channel offers accessible prices.  The removal of hydroquinone from the over-the-counter market would significantly impact my circle of friends for two reasons 1. Many have no health insurance and thus also have no access to prescriptions or 2.  The few with insurance report it is not covered by insurance and thus is far too expensive a course for them to pursue, particularly in todays environment of escalating costs of just the insurance premium, energy prices, mortgage and property taxes.



Based upon my research, I have discovered a couple of items for the FDA to take note:  



-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.



Again, I urge the FDA not pursue a change in the status of over-the-counter (OTC) skin bleaching drug products containing hydroquinone to prescription only.



In fact, I belive the FDA is misdirected in this pursuit;  I think the FDA should consider action on parabens, pthalates, toulene and other proven hormone-disruptors in cosmetics.  I am also greatly concerned regarding petroleum based products, lip products in particular, that have proven to be carcinogenic and contributable to breast cancer.



Regards,

Sheila Foreman

Dallas, TX 75206