News Room

CTFA Statement on Hydroquinone

May 1, 2007

Contact:  Lisa Powers, CTFA (202) 331-1770

For more than 30 years, hydroquinone has been on the market as an over-the-counter (OTC) drug for the treatment of age spots, small discolorations of the skin and dark marks from skin injury, acne or rashes.  It is the only recognized OTC treatment for improving the appearance of disfiguring and emotionally devastating pigmentary skin conditions.  When used as directed on small surface areas of the skin, hydroquinone is a safe and effective treatment recognized by consumers and dermatologists alike. 

On August 29, 2006, the U.S. Food and Drug Administration (FDA) proposed that skin bleaching drug products containing hydroquinone should not be available over-the-counter.  The FDA requested additional data, stating in its proposal, “the actual risk to humans from the use of hydroquinone has yet to be fully determined.”

In its proposal, FDA based some of its concern on data from countries such as South Africa, where there have been reports of adverse health affects such as ochronosis.  This condition is extremely rare in the U.S.  It is important to note that in such countries, hydroquinone was misused to lighten large surface areas of the skin using products containing high concentrations for prolonged periods of time.  The Agency also requested additional information and data about hydroquinone when tested on mice at higher doses, which has been reported to cause cancer.  No cases of cancer in humans have been reported.  It is important to note that tests performed on rats and mice include hydroquinone dispensed in extremely high doses, which is significantly different from actual use.

Studies conducted by other governmental agencies have reviewed and assessed the carcinogenic potential of hydroquinone and found no risk or unlikely risk when applied topically.  For example:

  • The International Agency for Research on Cancer (IRAC) concluded in 1999 that there is “inadequate evidence in humans for the carcinogenicity of hydroquinone and limited evidence in experimental animals for the carcinogenicity of hydroquinone.”
  • The Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers concludes, “Hydroquinone is unlikely to pose a toxic and/or carcinogenic risk when applied topically.”
  • The American Conference of Governmental Industrial Hygienists categorizes hydroquinone as ‘A3’ meaning that “there is evidence that it is carcinogenic in animals, but the relevance for humans is not known.”

The potential ban of hydroquinone would impact millions of Americans affected by disfiguring skin pigmentation conditions.  Leading dermatologists consider hydroquinone to be safe and effective and the most appropriate therapy for treating pigmentary disorders.

Based on the literature currently available, CTFA believes that a complete re-evaluation of the current medical/toxicology data, as well as new data on the health effects of hydroquinone would help address any potential concerns regarding hydroquinone’s risk from topical application.  In response to the proposed rule change, CTFA filed comments summarizing its evaluation of the information already reviewed by FDA, as well as new safety information that the Agency has not considered.  A copy of CTFA’s comments can be found at www.ctfa.org.