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Hydroquinone skin bleaches

This article was originally published in The Rose Sheet

Executive Summary

NDMA requests FDA feedback meeting on ongoing industry-sponsored research on the safety of hydroquinone-containing skin lighteners in Jan. 4 letter to the agency. The letter accompanies research data and dermatologist survey data that NDMA says 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." At an industry symposium in October, FDA said that hydroquinone will "probably" become nonmonograph ("The Rose Sheet" Oct. 11, In Brief). A 1989 National Toxicology Program rodent study linked the ingredient to possible carcinogenic effects, and the New York City Department of Consumer Affairs requested a ban on the products in February 1992 based on concerns over a connection between skin bleaches and exogenous ochronosis
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