Executive Summary

NDMA requests FDA feedback meeting to discuss ongoing industry-sponsored research on the safety of hydroquinone- containing skin lighteners in a Jan. 4 letter to the agency. The letter accompanies research data and dermatologist survey data that NDMA said support the conclusions that: "hydroquinone in OTC skin lightening preparations does not present a carcinogenic risk when used according to label directions"; and "ochronosis is a rarely reported event and there are no scientific data to specifically point to currently marketed OTC hydroquinone- containing preparations as causes of exogenous ochronosis." FDA said at an industry symposium in October that hydroquinone will "probably" become nonmonograph ("The Tan Sheet" Oct. 18, In Brief)...