The U.S. Food and Drug Administration (FDA) will host series of four webinars to provide detailed information about the agency’s September 2022 guidance, titled, “Infant Formula Transition Plan for Exercise of Enforcement Discretion.” The webinar will also address stakeholder questions.
The guidance outlines a pathway for manufacturers that are producing infant formula under an enforcement discretion to market infant formula products that may not currently comply with specific FDA requirements, while working toward meeting federal requirements. Under the new guidance, the period of enforcement discretion for products identified in the letters of enforcement discretion will be extended until January 6, 2023, with further extensions possible for firms that express interest in, and take steps toward, the lawful marketing of infant formula products in the U.S.
Each of the webinars begin at 2:00 P.M. ET on their respective dates, and will have a specific focus:
- October 21, 2022: Infant Formula Enforcement Discretion Transition Guidance Overview
- November 4, 2022: New Infant Formula Submission Requirements
- November 10, 2022: Quality Factor Requirement—Sufficient Biological Quality of Protein
- November 17, 2022: Quality Factor Requirement—Normal Physical Growth