OTC teeth whiteners

"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. . . .