‘Vast Majority’ Of Antibac Soaps Need Reformulation Under FDA Final Rule
This article was originally published in The Pink Sheet
Executive Summary
FDA says the “vast majority” of roughly 2,100 consumer antibacterial soaps on the market contain at least one of 19 antimicrobial ingredients banned from OTC use under new final rule. Industry, which suggests the agency is overstating the rule’s impact, is focused on delivering supporting data for three active ingredients still pending before FDA for GRASE use in the category.
You may also be interested in...
ACI Still Musing On ‘Two Islands Study’ For OTC Consumer Antiseptics While Ticking GRASE Data Boxes
ACI’s James Kim, vice president of science and regulatory affairs, provides an overview of the cleaning product industry’s ongoing efforts to fill GRASE data gaps previously identified by the US FDA, which the trade group expects to be reasserted under newly legislated FDA administrative order procedures.
FDA Rule Marks Consumer Antibac Soaps A Possible Endangered Species
FDA’s rule “clarifies the mission” for manufacturers of consumer antibacterial soaps, which have a year to demonstrate that they are safe and effective or risk losing the entire OTC drug category.
FDA Says Antiseptics Need Testing Or Face Reformulation, Relabeling
FDA proposes to amend the OTC antiseptic drug product monograph to require more detailed safety and efficacy tests, pointing to mounting data that shows antibacterial wash products could pose health risks and contribute to increase antibacterial resistance.