1978N-0065 Skin Bleaching Drug Products
FDA Comment Number : EC555
Submitter : Dr. Michelle Lee Date & Time: 01/03/2007 08:01:41
Organization : Michelle H. Lee, M.D., Prof. Corp
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
To the FDA: As a member of the American Society of Dermatologic Surgery(ASDS), I oppose the FDA's proposed rule change for the following reasons: hydroquinone is used to treat dyschromia, a condition with significant morbidity, which affects millions of Americans, many of whom are in minority groups. Requiring a new drug application of hydroquinone would be punitive to dyschromia patients and potentially inequitable to people of various minority groups. The association of cancer in humans is unproven and existing animal data do not support removal of these products from the market.

Regards,
Michelle H. Lee, M.D.