FDA to Host Webinar Series to Discuss the Infant Formula Transition Plan for Exercise of Enforcement Discretion

Image courtesy of FDA

The U.S. Food & Drug Administration (FDA) will host a 4-part webinar series to provide more in-depth information about the details outlined in the Infant Formula Transition Plan for Exercise of Enforcement Discretion and address questions.

The guidance outlines a pathway for manufacturers of infant formula under enforcement discretion to market infant formula products that may not currently comply with specific FDA requirements while they work toward meeting those requirements. Under the new guidance, the period of enforcement discretion for those products identified in the letters of enforcement discretion will be extended until Jan. 6, 2023, with further extensions possible for firms that express interest in and take steps toward the lawful marketing of such products in the United States. The guidance balances the need to ensure that infant formula products meet regulatory requirements with the need for a more resilient infant formula supply.  

Each webinar 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

Each webinar starts at 2:00 pm ET.

Registration is required. One registration provides access to all four webinars.

To register, visit https://www.surveymonkey.com/r/MVHQ337.

Each webinar will be recorded and posted to the meeting page.