Dental Association Petitions FDA To Evaluate Tooth-Whitening Treatments
This article was originally published in The Rose Sheet
Executive SummaryThe American Dental Association asks FDA to follow through on its promise to evaluate the safety of tooth-bleaching systems and classify the regulatory status of the products, which are rapidly increasing in number
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Data in a 2009 petition submitted by the American Dental Association is insufficient to warrant a drug designation for peroxide-containing tooth-whitening products as a group, according to the agency’s April 22 response. Further information on specific product formulations, mechanisms of action and safety profiles would be required for FDA to determine whether they meet the definition of a drug under federal law, the agency says.