1978N-0065 Skin Bleaching Drug Products
FDA Comment Number : EC482
Submitter : Ms. Doreen Duryea Date & Time: 12/22/2006 08:12:00
Organization : Ms. Doreen Duryea
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
While I am all in favor of safety, there is no reason to believe that these products, when applied topically, are unsafe. I have talked with many doctors on the subject and researched the issues around the globe with Mercury content. Additionally, the FDA is quoting studies where this drug was injected into pregnant rats and mice in huge amounts rather than being applied topically. Where is the comparison? It has helped me with a repigmentation problem on my face that was once embarrassing.