Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States

Infant formula is a primary or supplementary source of nutrition for many infants in the U.S. Consequently, disruptions to the supply of infant formula can have a severe impact on infants' health and well-being. In late 2021 and early 2022, a recall of specific infant formula products, followed by a pause in production, resulted in a widespread, national shortage. The incident demonstrated that additional risk management planning is needed to protect infants from the consequences of potential future supply chain disruptions.


In 2023, the U.S. Food and Drug Administration contracted with the National Academies to convene an expert committee to examine and report on challenges in supply, market competition, and regulation of infant formula. The resulting consensus study report explains policy and marketplace vulnerabilities that were exposed during the shortage, describes the extent to which actions taken by relevant stakeholders addressed these vulnerabilities, identifies remaining gaps in the system, and recommends actions to reduce the risk and lessen the effect of any future disruption to the infant formula supply chain.

Table of Contents


Front Matter
Summary
1 Introduction
2 Methodology
3 Infant Formula Regulatory Framework Before the 2022 Shortage
4 Infant Formula Demand and Supply Before the 2022 Shortage
5 2022 Infant Formula Shortage and Response
6 Vulnerabilities and Recommendations
7 Concluding Remarks
Appendix A: Committee Member Biographies
Appendix B: Disclosure of Unavoidable Conflict of Interest
Appendix C: The 2022 Infant Formula Shortage Timelines and Actions
Appendix D: Information-Gathering Public Sessions
Appendix E: Other Committees' Charges Relevant to Infant Formula
Appendix F: Infant Formula Regulatory Requirements in the United States, Australia, New Zealand, Canada, and the European Union, and How They Compare to Codex
Appendix G: Description of the International Code of Marketing of Breast-Milk Substitutes
Appendix H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category
Appendix I: Special Supplemental Nutrition Program for Women, Infants, and Children Breastfeeding Support
Appendix J: Special Supplemental Nutrition Program for Women, Infants, and Children Participants' Experiences During the Formula Shortage
Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification