- 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.
Read the association’s complete comments here.
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.