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OTC teeth whiteners

Executive Summary

"Are unapproved new drugs," FDA tells six manufacturers in recent warning letters. Center for Drug Evaluation and Research Compliance Office Director Dan Michels sent warning letters on Sept. 4 to the marketers of EpiSmile, Instant White and Omni White & Bright, and another three letters on Sept. 9 to the manufacturers of Rembrandt Lighten; Instant White, Dental White, Ultimate White and Dazzle; and Dentlbright. The products, which bear claims for the bleaching of teeth, include ingredients such as calcium peroxide, hydrogen peroxide, carbamide peroxide and perhydrol urea. . . .

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Dental Association Petitions FDA To Evaluate Tooth-Whitening Treatments

The 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

Dental Association Petitions FDA To Evaluate Tooth Whitening Treatments

The American Dental Association asks FDA to follow through on its promise to evaluate the safety of the rapidly increasing number of tooth bleaching products and classify their regulatory status

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