10.21.21
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:
“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, VP-science & regulatory affairs, ACI. “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 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; and
- 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, VP-science & regulatory affairs, ACI. “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.”