FDA Increases Staff, Creates New Office to Strengthen Infant Formula Oversight

FDA has released an update on actions the agency has taken, and those underway, to strengthen the safety and resiliency of the supply of infant formula. The update includes release of a progress report specific to actions the agency has taken to meet the recommendations in the FDA’s Evaluation of the Infant Formula Response.

The update highlights notable actions, including:

• Hiring and providing specialized training to personnel dedicated to the oversight of critical foods, including formula; this includes setting up a dedicated critical foods inspectional cadre and establishing a new Office of Critical Foods.
• Updating and improving the FDA’s infant formula compliance program, which outlines the agency’s inspectional and compliance approach to infant formula.
• Supporting the Council of State and Territorial Epidemiologists position on elevating Cronobacter to a nationally notifiable disease. 
• Increasing the diversity of infant formula available in the U.S., especially through the agency’s transition plan for firms that had previously received a letter of enforcement discretion.
• Continuing to build on FDA’s Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula, which aims to broaden scientific knowledge, improve oversight, and enhance communications and engagement with industry consumers and other stakeholders.
• Issuing warning letters to infant formula manufacturers as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that manufacturers are producing infant formula under the safest conditions possible.

For a more comprehensive list of actions that the Agency has taken, see the Status Update on FDA’s Infant Formula Response Activities. For more specifics on steps the agency has taken in response to the FDA’s Evaluation of the Infant Formula Response, see the Progress Update.