US Unveils National Strategy on Safe & Nutritious Infant Formula Supply

On March 28, 2023, U.S. Food and Drug Administration (FDA) issued an Immediate National Strategy (hereinafter the Strategy), aiming to increase the resiliency of safe, nutritious infant formula supply in the US. The Strategy responses to a months-long infant formula shortage, which was sparked by insanitary conditions at one of the nation's largest infant formula facilities.

The Strategy describes FDA's efforts to address shortages and details the agency plans to increase the resilience of the infant formula market.

1. Ensure that the industry understands the requirements for developing and implementing a redundancy risk management plan;

2. Continue to strengthen inspections on infant formula manufacturers, including by expanding and improving infant formula training for investigators and conducting food safety inspections on all infant formula manufacturers at least annually;

3. Expedite review of premarket submissions for new infant formula products, so as to alleviate or prevent shortages;

4. Continue to monitor infant formula supplies and develop predictive models, so as to enable FDA to prepare for and mitigate future supply disruptions.

Besides, the Strategy mentions that the FDA is working together with government partners, such as the U.S. Department of State and the United States Department of Agriculture (USDA), to identify multiple issues beyond the FDA's purview.

1. Determine whether foreign infant formula manufacturers have the ability to immediately export regular and specialty formulas to the U.S., and notify manufacturers to provide additional information on their manufacturing processes, capacities and formulations;

2. Support efforts to build resiliency within its Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

3. Work with the U.S. government partners to address urgent infant formula needs, especially where those partners have the ability to influence and build long-term resiliency for infant formula supply chains outside of FDA's control. For example, consider whether tariffs play a role in market diversification, and assess whether the support is enough for the construction of new and updated infant formula production facilities.

4. In consultation with industry and other stakeholders, refine Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula to improve the overall safety of infant formula and minimize the potential of supply chain disruption.