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FDA Denies Petition To Classify Home Tooth Whiteners As Drugs

This article was originally published in The Rose Sheet

Executive Summary

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.


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