ACI Provides Comments to FDA on Topical Antiseptics Program

The American Cleaning Institute (ACI) provided comments to the US Food and Drug Administration (FDA) at the Agency’s Over-The-Counter Monograph Drug User Fee Program (OMUFA) Reauthorization Public Meeting on November 20. The meeting was held at the FDA Headquarters at the White Oak Campus in Silver Spring, MD.

Dr. James Kim, ACI SVP, science and regulatory affairs, provided comments regarding the Topical Antiseptics Program, focusing on getting clearer feedback from FDA on GRAS/E expectations, and a pathway for dispute resolution.

Dr. Patrizia Cavazzoni (FDA Center Director, CDER) and Dr. Theresa Michele (FDA Director, Office of Non-Prescription Drugs, CDER) kicked off the meeting by providing an overview of OMUFA and the reauthorization process.  The reauthorization process was initiated by a public meeting in September 2023, where ACI provided comments and participated in the subsequent industry-FDA discussions.

For this meeting, marking the completion and agreement on the OMUFA goals for 2026-2030 (OMUFA II), FDA invited perspectives from the regulated community, as well as academic and advocacy perspectives.  The OMUFA Performance Goals and Procedures will be transmitted to Congress for approval in early 2025.

Read the association’s complete comments here.