September 28, 2023
(press release)
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As the Food and Drug Administration (FDA) kicks off efforts that will determine user fees that fund the Agency’s review of nonprescription drugs, the American Cleaning Institute (ACI) urged regulators to confront the issue of “free riders”: companies that benefit off the backs of those who are funding research aimed at meeting FDA data requests, but who don’t participate in the research. Background: A group of ACI members support a multi-year, multi-million dollar research effort to develop safety and efficacy data for topical antiseptic products like antibacterial soaps and hand sanitizers, in order to meet FDA’s regulatory requirements. ACI members continue to work diligently on the studies that FDA had requested to establish General Recognition of Safety and Effectiveness (GRASE) status for these drug products. The issue at hand: The long-term commitments ACI and our members are making to fill the data gaps are very costly and resource intensive, said Douglas Troutman, ACI General Counsel and Senior Vice President of Government Affairs, at an FDA public meeting. ACI also called for greater transparency in FDA processes governing dialogue with industry, as “understanding FDA expectations is critical for ACI and its members to continue making necessary investments to ensure topical antiseptic studies requested by FDA can be completed.” Among the recommendations made by ACI: The companies supporting ACI’s topical antiseptic research efforts use or manufacture the ingredients ethanol, benzalkonium chloride, benzethonium chloride, chloroxylenol, and povidone-iodine. The American Cleaning Institute® (ACI – www.cleaninginstitute.org) is the Home of the U.S. Cleaning Products Industry® and represents the $60 billion U.S. cleaning product supply chain. ACI members include the manufacturers and formulators of soaps, detergents, and general cleaning products used in household, commercial, industrial and institutional settings; companies that supply ingredients and finished packaging for these products; and chemical distributors. ACI serves the growth and innovation of the U.S. cleaning products industry by advancing the health and quality of life of people and protecting our planet. ACI achieves this through a continuous commitment to sound science and being a credible voice for the cleaning products industry.
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