What is the NTP and why is hydroquinone being studied under the NTP?
The NTP consists of scientists who evaluate substances for a variety of health-related effects. The NTP provides the study results to Federal Regulatory Agencies such as the FDA so that we can use the results to make better informed regulatory decisions. We believe that additional animal studies, such as dermal toxicity and carcinogenicity, are needed to better understand if topically applied hydroquinone may be harmful to humans. After we published the 2006 proposed rule, we received many submissions from the public, but none of them included new study data. Therefore, we nominated hydroquinone for further study by the NTP. We believe that the NTP studies are necessary before we can determine whether hydroquinone is safe and effective (GRASE) when used in OTC skin bleaching drug products. When will the NTP hydroquinone studies begin? Our nomination of hydroquinone was reviewed at a public meeting of the NTP Board of Scientific Counselors on December 10, 2009, at which time the nominat
