American Cleaning institute (ACI) Questions FDA Proposal for Antiseptics (November 2015)The American Cleaning Institute (ACI) recently questioned the FDA's proposal for companies that produce health care antiseptics to provide additional data on safety and effectiveness. Instead of seeking additional data from all manufacturers of antiseptics, ACI said that FDA should begin by re-evaluating data already submitted by manufacturers and mark substances that are generally recognized as safe and effective (GRASE). ACI proposed that only if FDA finds specific gaps in data for active ingredients already in antiseptics should they require additional data on the safety and efficacy of products.
ACI's comments over the requirement for additional data comes after the FDA's proposal earlier this year requesting follow up scientific data on the effects of active ingredients in healthcare biocides marketed under the over-the-counter (OTC) monograph.
For more information see the FDA press release and the U.S. ACI Comments webpage: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm445002.htm and http://www.cleaninginstitute.org/aci_urges_fda_to_preserve_critical_healthcare_antibacterial_products_ingredients/