FDA Publishes Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market

On January 10, 2025, the Food and Drug Administration (FDA) announced publication of its Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market (the “long-term strategy”).

Background

The long-term strategy builds upon the Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market (the “immediate strategy”) that FDA issued in 2023, in response to the infant formula shortage that began in 2022. The immediate strategy included observations, immediate actions, and the agency’s short-term plans to “improve the resiliency of the U.S. infant formula supply.” At that time, FDA also initiated work with the National Academies of Sciences, Engineering and Medicine’s (NASEM) to study issues related to the U.S. infant formula market. FDA states that the long-term strategy was informed by NASEM’s report, “Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States,” as well as learnings from the immediate strategy and insights from various stakeholders.

Key Objectives in the Long-Term Strategy

The long-term strategy is organized according to 5 “objectives” for the agency. For each, FDA has delineated planned actions to promote that objective. Below, we list the 5 objectives and examples of FDA’s key planned actions associated with that objective.

Objective 1: Ensure the Proper Oversight of Safe Infant Formula Production. FDA intends to enhance its “oversight of infant formula production and assist industry with contamination prevention efforts.” Examples of FDA’s plans to implement this objective include:

• Conduct surveillance inspections of infant formula manufacturers at least annually, and use voluntary remote regulatory assessments, when appropriate.
• Set annual sample collection targets for microbiological and nutritional analysis for foreign manufacturers.
• Improve knowledge relating to contamination by receiving scientific data from the The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) regarding industry and public health interventions to address Cronobacter in powdered infant formula and engaging with industry on best practices for sampling, corrective actions, and root cause analysis.
• Continue to improve the agency’s processes, including for handling consumer/whistleblower complaints.

Objective 2: Strengthen the Resiliency of the Infant Formula Supply Chain. In order to “protect the integrity” of the infant formula supply chain and promote new market entrants, FDA plans to:

• Track and monitor the infant formula supply; develop a forecasting model for future events and disruptions; and work to identify manufacturer and supplier concentration risks (as well as other “critical points of failure”).
• Complete pre-market review of infant formula submissions (especially for new products), including those from manufacturers under FDA’s transition plan.
• Enforce (especially for specialty infant formula) the Redundancy Risk Management Plans (RRMPs) requirement.
• Consider approaches for potential international harmonization of infant formula regulatory requirements, and collecting information on infant formula requirements from other countries to facilitate use of enforcement discretion in the event of shortage.

Objective 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. To collaborate with government partners, FDA plans to:

• Engage with the Department of Health and Human Services (HHS) to conduct risk management planning, with the Centers for Disease Control and Prevention (CDC), experts, and manufacturers to explore jointly developing information on how caregivers can safely substitute formula, and with the Centers for Medicare & Medicaid Services (CMS) to ensure hospitals have plans for disruptions.
• Engage with United States Department Agriculture (USDA) regarding the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) to: help manufacturers meet expectations under RRMPs standards to qualify as “responsive” bidders, consider strengthening infant formula WIC contract flexibilities, and distribute consumer education materials.
• Support USDA in updating the Guide to Coordinating WIC Service During Disasters, researching, research recommendations about iron level requirements for WIC infant formula, and exploring a WIC governance structure framework for crisis response.

Objective 4: Ensure Timely Communication with Industry, Consumers, and Other Stakeholders on Infant Formula Issues of Public Health Significance. To communicate with stakeholders, FDA plans to:

• Host a webinar to assist manufacturers under the transition plan and in making new infant formula submissions; communicate with manufacturers on production levels, raw materials, and distribution; and provide manufacturers information on mandatory reporting of potential shortages of product, raw materials, and ingredients, and the importance of specialty infant formula supply chains.
• Work with healthcare providers and USDA’s Food and Nutrition Service (FNS) (which administers WIC) to promote consumer education.
• Develop communication materials for when infant formula is unavailable, develop a public list of all currently marketed and registered US infant formulas.

Objective 5: Continually Evaluate Authorities for Infant Formula, While Ensuring Necessary Regulations and Guidances are Clear and Science-Based. Finally, to “enhance its oversight,” FDA will:

• Consider new information to determine whether regulatory and/or guidance updates are needed, including the results of the NASEM study on possible alternatives to the Protein Efficiency Ratio (PER) and growth monitoring studies. FDA will also evaluate current finished product pathogen testing requirements.
• Publish several guidance documents, including “PER Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein: Guidance for Industry.”
• Explore regulatory standards/guidance relating to RRMPs.
• Continue to work with Congress, where appropriate, to:
  • encourage manufacturers to implement RRMPs and modernize manufacturing;
  • require manufacturers to provide notice of a decision to discontinue a critical food likely to lead to a meaningful disruption;
  • obtain mandatory authority for remote access to manufacturer records; and
  • assist Congress in considering suspending tariffs on imported formula/inputs in the case of a disruption.

* * *

The long-term strategy also describes, in the Appendix, actions that FDA has taken in the past year relating to infant formula. FDA discusses actions intended to enhance oversight of safe infant formula production, support supply chain resilience, work with government partners to strengthen that supply chain, communicate with stakeholders, and enhance the agency’s oversight (i.e., new authorities, regulations, and guidance). 

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.