Following the infant formula crisis of 2022, the FDA has announced action to reduce the probability of infection of infant formula with pathogens including Cronobacter sakazakii.

Manufacturers of infant formula are now obliged to develop, maintain and implement risk management plans as mandated by the Food and Drug Omnibus Reform Act of 2022.

Implicit in the intensified initiative are: -

• Ongoing collaboration with industry and coordination with academia and consumer groups to enhance the safety of infant formula.
• A requirement that manufacturers share safety data.
• Appointment of FDA personnel dedicated to infant formula.
• Support of the program through the Office of Critical Foods.
• Supporting the status of Cronobacter infection as a notifiable disease.
• Improving communication relating to infant formula with respect to consumers and industry.