American Cleaning Institute addresses FDA on Topical Antiseptics Program; organization seeks clearer feedback on GRAS/E expectations at Over-The-Counter Monograph Drug User Fee Program meeting

• Comments emphasize the need for clearer Agency feedback to industry and a pathway for dispute resolution

The American Cleaning Institute (ACI) provided comments to the U.S. Food and Drug Administration (FDA) at their Over-The-Counter Monograph Drug User Fee Program (OMUFA) Reauthorization Public Meeting on Wednesday, November 20 at the FDA Headquarters at the White Oak Campus.

Dr. James Kim, ACI Senior Vice President, Science & 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.