On October 12, 2022, FDA announced that it would be hosting a 4-part webinar series to provide more information regarding the Infant Formula Transition Plan for Exercise of Enforcement Discretion. Each of FDA’s webinars 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

By way of background, and as previously reported, on May 16, 2022, FDA released a guidance document with the Agency’s plan to increase the supply of infant formula through the exercise of its enforcement discretion for certain non-compliant formula.  On September 30, 2022, FDA announced a new guidance, the Infant Formula Transition Plan for Exercise of Enforcement Discretion, which details the pathway for manufacturers of infant formula working under the enforcement discretion to market infant formula products as they work toward meeting FDA’s requirements.

The webinars begin at 2:00 pm Eastern Time. Registration is required for the webinar and interested parties may register at: https://www.surveymonkey.com/r/MVHQ337. Each webinar will also be recorded and posted to the meeting page.