1978N-0065
  

  
Skin Bleaching Drug Products
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC151
  



  

  
Submitter : 
  

  
Mrs. Jill Berner
  

  
Date & Time: 
  

  
12/18/2006 09:12:03
  



  

  
Organization : 
  

  
Mrs. Jill Berner
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Regarding the FDA's consideration of the removal of the bleaching agent hydroquinone from easily accessible over-the-counter skin bleaches, I am in agreement with board certified dermatologist Audrey Kunin (who has more than 20 years of experience) who says the following: 



While it is true that the use of hydroquinone can cause an increase in skin discoloration rather than the desired bleaching effect (a condition called exogenous ochronosis), this is extremely rare. I have never seen a single patient of mine, regardless of race, develop a case of exogenous ochronosis or any other medically concerning side effect associated with the use of either OTC or prescription hydrocortisone. Nor have I seen an increase in any type of cancer in patients who have used hydroquinone. 



In addition, having what I believe is the world's largest skin health and beauty advice column serving several millions of consumers worldwide, after 8 years in business, I have never received an email with respect to medically concerning issues related to the use of hydroquinone, either.

The removal of hydroquinone from the over-the-counter market would significantly impact millions of consumers who either have no access to prescriptions and medical care or are unaware of their availability. 



Prescription hydroquinone products are typically not covered by medical insurance and are far too expensive for most patients, unlike those hydroquinone-based bleaches which are easily available over-the-counter. 



I am in complete agreement with the American Academy of Dermatology's following statements: 



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.



I request that the FDA NOT remove hydroquinone from the list of acceptable ingredients for OTC products.