The American Cleaning Institute (ACI)

ACI Submits Progress Report to FDA for Topical Antiseptics Program


The American Cleaning Institute (ACI) provided a report to the Food and Drug Administration (FDA) describing specific progress on all ongoing studies within ACI’s Topical Antiseptics Program (TAP), addressing safety and efficacy data gaps for critical antiseptic ingredients.

The progress report submitted to FDA:

  • Provides a status update of data generation activities across multiple active ingredients ACI is supporting (benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol and povidone-iodine) for the regulations FDA has proposed or is contemplating for consumer antiseptic wash products, health care antiseptic products, consumer antiseptic rub products and food handler antiseptic products
  • Demonstrates ACI’s commitment to fill data gaps while FDA continues to develop and implement processes of OTC monograph reform such as a data submission platform and meeting request procedures
  • Notes specific projects that have been delayed due to restrictions at research facilities and specialized testing laboratories, due to the COVID-19 pandemic
  • Summarizes the status of key milestones identified in the 2020 Progress Report and Work Plan
  • Identifies key milestones for the upcoming 12 months demonstrating anticipated progress towards filling safety and efficacy data gaps

“The commitments ACI and our members are making to fill the safety and efficacy data gaps are long term and resource intensive in labor and expenditures to conduct the studies requested by FDA,” said Dr. James Kim, ACI Vice President of Science & Regulatory Affairs. “In order for industry to continue to make such investments, it is imperative that FDA expeditiously implements OTC monograph reform to clarify procedures and processes for meeting FDA’s expectations.”

The American Cleaning Institute® (ACI – 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.