FDA Denies Petition To Classify Home Tooth Whiteners As Drugs

摘要

FDA says there is insufficient information to classify peroxide-containing tooth-whitening products as drugs, denying an American Dental Association petition submitted in November 2009 on the basis of claimed safety concerns. In an April 22 response to the citizen petition, FDA maintains that more information is needed for the agency to consider a drug designation for tooth-whitening preparations that act by chemical means to lighten tooth color.