Industry may have known which way the wind was blowing for triclosan and triclobarban use in OTC consumer antibacterial soaps, but now the pressure is on to demonstrate the safety and efficacy of three remaining active ingredients lest FDA effectively close down the entire category.
FDA Rule Marks Consumer Antibacterial Soaps An Endangered Category
FDA’s final rule “clarifies the mission” for manufacturers of consumer antibacterial soaps, which have a year to demonstrate that benzalkonium chloride, benzethonium chloride and chloroxylenol are safe and effective or risk losing the entire OTC drug category. The rule bars firms from marketing consumer antiseptic wash products containing triclosan, triclocarban and 17 other lesser-used active ingredients.