IHS Chemical Week

Chemical Week Magazine :: Regulatory

FDA Cites P&G for Improper Triclosan Claims

9:13 AM MDT | October 3, 2007 | Nancy Seewald

The FDA says Procter & Gamble (P&G) violated the federal Food, Drug, and Cosmetic Act by claiming its triclosan-based hand sanitizer, sold under the name Early Defense, can “prevent colds and provide antimicrobial activity for up to three hours.” FDA says the product’s claims and directions for use cause it to be an unapproved new drug under the act, and are inconsistent with labeling allowed under FDA’s over-the-counter drug rules. FDA says it is not aware of significant health risks associated with the product, but says that the...

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