The U.S. Food and Drug Administration (FDA) has provided an update on its completed and ongoing actions to strengthen the safety and resiliency of the nation’s supply of infant formula, including specific actions the agency has taken to meet the recommendations made in FDA’s evaluation of the infant formula crisis response.
Notable actions recently taken by FDA include:
- Hiring and providing specialized training to personnel dedicated to the oversight of critical foods, including infant formula. This includes setting up a dedicated critical foods inspectional cadre and establishing a new Office of Critical Foods. Both actions provide FDA with resources and expertise that are focused solely on critical foods, and which facilitate enhanced oversight of these commodities.
- Updating and improving FDA’s infant formula compliance program, which outlines the agency’s inspectional and compliance approach to infant formula, to help ensure that infant formula products in the U.S. food supply are safe and nutritious.
- Supporting the Council of State and Territorial Epidemiologists (CSTE) position on elevating Cronobacter to a nationally notifiable disease, which was a critical step toward better understanding how these illnesses occur and spread, who is most at risk, and what can be done to prevent Cronobacter-related illnesses.
- Increasing the diversity of infant formula available in the U.S., especially through FDA’s transition plan for firms that had previously received a letter of enforcement discretion.
- Continuing to build on FDA’s commodity-specific prevention strategy for Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula, which aims to broaden scientific knowledge, improve oversight, and enhance communications and engagement with industry, consumers, and other stakeholders.
- Updating and streamlining infant formula-related materials on FDA.gov to provide consumers, industry, and medical professionals with more accessible information, including materials on infant Formula and C. sakazakii, as well as a new resource in both English and Spanish on handling infant formula safely.
- 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.
