FDA antiseptic TFM "broad enough" to cover antibacterial lotions -- industry petition.
This article was originally published in The Rose Sheet
Executive Summary
FDA ANTISEPTIC TFM "BROAD ENOUGH" TO INCLUDE ANTIMICROBIAL LOTIONS, CTFA and other industry trade groups maintain in a June 12 citizen petition to the agency. Submitted in conjunction with the Soap and Detergent Association and the Nonprescription Drug Manufacturers Association, the Cosmetic, Toiletry and Fragrance Association petition argues the scope of the tentative final monograph for OTC health care antiseptic drug products covers lotions making antibacterial claims. The section of the TFM addressing the antiseptic handwash category "is broad enough to encompass antimicrobial hand lotions, particularly in light of the fact that the TFM provides specific label directions for application of antiseptic handwashes without water or rinsing," the industry groups assert.