FDA launches strategy to strengthen infant formula supply chain

Building resilience

The 2022 crisis, triggered by a product recall and temporary shutdown at Abbott Nutrition's facility in Sturgis, Michigan, exposed the fragility of the U.S. infant formula supply chain. At the time, four manufacturers controlled 99% of the market, creating a precarious dependency on a few players. Although efforts have stabilized the market since then, systemic vulnerabilities persist, with three manufacturers controlling most of the supply in 2024 -- Abbott, Mead Johnson and Nestle (Gerber).

The FDA's long-term national strategy seeks to address these challenges through a collaborative, prevention-focused approach. It builds upon the Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market introduced in March 2023, leveraging input from federal agencies such as the CDC, CMS and the U.S. Department of Agriculture (USDA), as well as insights from healthcare professionals, consumer advocacy groups and industry stakeholders.

In the FDA's words, "No single agency can resolve the vulnerabilities in the infant formula market, but together with our U.S. Government partners, we are working to improve the resilience of the U.S. infant formula market for all consumers."

Key strategy objectives

The five key strategies outlined in the FDA's Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market include the following:

1. Ensure the proper oversight of safe infant formula production.
2. Strengthen the resiliency of the infant formula supply chain.
3. Continue to work with U.S. government partners at the federal, state, local, territorial and tribal levels involved in the production, distribution or sale of infant formula.
4. Ensure timely communication with industry, consumers and other stakeholders on infant formula issues of public health significance.
5. Continually evaluate authorities for infant formula, while ensuring necessary regulations and guidances are clear and science-based.

Objective 1: Enhanced oversight of infant formula production

The FDA plans to ensure the safety and quality of infant formula by conducting annual inspections of all domestic and foreign manufacturers. These inspections will focus on microbiological and nutritional analysis to detect potential risks early, prevent contamination and avoid recalls. The agency has prioritized the training of inspectors to enhance their ability to conduct thorough evaluations, especially in response to past safety issues.

Collaboration with the National Advisory Committee on Microbiological Criteria for Foods is a critical element of this oversight. The committee will help develop strategies to prevent contamination by Cronobacter sakazakii, a pathogen linked to rare but life-threatening infections in infants consuming powdered formula.

The FDA highlighted the importance of this work by stating, "Safe production is essential for a steady supply of infant formula to U.S. consumers."

Objective 2. Strengthening supply chain resilience

To address vulnerabilities in the infant formula supply chain, the FDA is implementing new initiatives to improve market stability and preparedness. Predictive modeling tools will be employed to identify early signs of supply disruptions, and state-level data analyses will be used to detect localized shortages.

Encouraging market diversity is a key focus, with efforts to attract new manufacturers and streamline the regulatory process for market entry. Manufacturers are now required to implement Redundancy Risk Management Plans (RRMPs) to reduce dependence on single facilities or suppliers, ensuring there is surge capacity to handle disruptions.

Objective 3: Collaboration with federal and state partners

Collaboration with other federal and state agencies is pivotal in the FDA's long-term strategy. The USDA's Women, Infants, and Children (WIC) program is central to this effort, as WIC participants account for approximately half of all U.S. infant formula purchases. Updated guidelines within the program now require emergency preparedness plans, alternate operating procedures and increased flexibility to ensure reliable formula access during disruptions.

The FDA is also working closely with the HHS, Customs and Border Protection, and state-level agencies to improve supply chain visibility and ensure a coordinated response during emergencies. These partnerships aim to address potential shortages quickly and support families in need.

Objective 4: Improved communication with stakeholders

The FDA recognizes that effective communication is essential to building a resilient infant formula supply chain. To enhance public education efforts, key resources are being translated into multiple languages, including Spanish, Arabic and Burmese. These materials aim to provide caregivers with clear guidance on safe formula preparation and handling, particularly for high-risk infants.

Additionally, the FDA is hosting webinars for manufacturers to share critical compliance and risk management practices. Collaboration with medical societies, such as the American Academy of Pediatrics, ensures healthcare professionals have access to updated tools and guidance to support families during supply disruptions.

The FDA is also working to establish a public database of marketed formulas, which will help caregivers make informed choices during shortages and enhance transparency in the marketplace.

Objective 5: Regulatory modernization for long-term resilience

To further strengthen the infant formula market, the FDA is seeking legislative authority to implement several critical measures. These include the establishment of binding contamination limits for infant formula, mandatory industry testing for pathogens, and requirements for manufacturers to provide preemptive notifications of potential supply disruptions.

These measures aim to enable faster responses to crises and enhance oversight. Additional proposals include tariff flexibility for imported formula and raw materials during shortages and streamlined regulatory pathways to expedite the entry of new products into the market. These steps are designed to modernize the regulatory framework, diversify the supply chain and ensure the long-term resilience of the infant formula market.

Industry Implications

For pharmaceutical and healthcare technology companies, the FDA's plan offers opportunities for innovation, particularly in supply chain analytics, production monitoring and compliance solutions. The focus on RRMPs underscores the need for robust risk mitigation strategies, while the agency's push for transparency creates opportunities for technologies that enhance supply chain visibility.

However, the new regulatory environment also poses challenges. Manufacturers must navigate heightened scrutiny, invest in compliance, and adapt to evolving requirements. Companies that align with these changes and leverage technologies -- such as artificial intelligence for predictive modeling or blockchain for traceability -- will be better positioned to succeed in this dynamic landscape.

The FDA's long-term national strategy is another step toward securing the future of the U.S. infant formula market. By focusing on collaboration, innovation, and regulatory modernization, the strategy was designed to ensure infants and families nationwide have consistent access to safe and nutritious formula.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.