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  1. CFSAN Constituent Updates

FDA to Host Stakeholder Call on Infant Formula Transition Plan for Exercise of Enforcement Discretion

Constituent Update

October 3, 2022

The U.S. Food & Drug Administration (FDA) will host a call for stakeholders on Wednesday, October 5, 2022 at 2 p.m. ET to provide a high-level overview of 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.

Date: October 5, 2022

Time: 2:00 p.m. ET

Call Link: Infant Formula Transition Plan for Exercise of Enforcement Discretion Stakeholder Call - YouTube

Agenda

  • Welcome and Introduction of Speakers/Technical Experts 
    LCDR Janesia Robbs, Communications and Public Engagement Staff, Center for Food Safety and Applied Nutrition (CFSAN), FDA
  • Opening Remarks
    Dr. Claudine Kavanaugh, Director, Office of Nutrition and Food Labeling, CFSAN, FDA
  • Overview of Infant Formula Transition Plan for Exercise of Enforcement Discretion
    Dr. Patricia A. Hansen, Deputy Director, Office of Nutrition and Food Labeling, CFSAN, FDA
  • Question & Answer Session
    LCDR Janesia Robbs, Communications and Public Engagement Staff, CFSAN, FDA
    • Dr. Claudine Kavanaugh, Director, Office of Nutrition and Food Labeling, CFSAN, FDA
    • Dr. Patricia A. Hansen, Deputy Director, Office of Nutrition and Food Labeling, CFSAN, FDA

For more information

 

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