Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States (2024)
Chapter: Front Matter
Consensus Study Report
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COMMITTEE ON CHALLENGES IN SUPPLY, MARKET COMPETITION, AND REGULATION OF INFANT FORMULA IN THE UNITED STATES1
BARBARA O. SCHNEEMAN (Chair), University of California (emeritus)
RAVI M. ANUPINDI (Vice Chair), University of Michigan
STEVEN A. ABRAMS, University of Texas at Austin
SUSAN S. BAKER, University of Buffalo
WENDY L. JOHNSON, All Things Healing, LLC
REYNALDO MARTORELL, Emory University
ZOË NEUBERGER, Center on Budget and Policy Priorities
DEBORAH L. O’CONNOR, University of Toronto
JENNIFER L. POMERANZ, New York University
KATHLEEN M. RASMUSSEN, Cornell University (emeritus)
KATHERYN RUSS, University of California, Davis
MELISSA A. SIMON, Northwestern University
BRIDGET E. YOUNG, University of Rochester
MARTA E. WOSIŃSKA, The Brookings Institution
Study Staff
KATHERINE M. DELANEY, Study Co-director
PATRICIA CUFF, Study Co-director
MELANIE ARTHUR, Senior Program Assistant
JENNIFER STEPHENSON, Research Associate
MELISSA MAITIN-SHEPARD, Science Writer
MICHELLE DELFAVERO, Science Writer
ANN L. YAKTINE, Food and Nutrition Board Director
___________________
1 See Appendix B, Disclosure of Unavoidable Conflict of Interest.
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Reviewers
This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.
We thank the following individuals for their review of this report:
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by HUGH TILSON, The University of North Carolina at Chapel Hill, and CATHERINE E. WOTEKI, Iowa State University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.
CHAPTER 4 INFANT FORMULA DEMAND AND SUPPLY BEFORE THE 2022 SHORTAGE
CHARACTERIZING THE DEMAND FOR INFANT FORMULA
CHARACTERIZING THE SUPPLY CHAIN
SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN
CHAPTER 5 2022 INFANT FORMULA SHORTAGE AND RESPONSE
EVENTS LEADING UP TO THE 2022 INFANT FORMULA SHORTAGE
U.S. GOVERNMENT RESPONSE TO THE 2022 INFANT FORMULA SHORTAGE
CHARACTERIZING SUPPLY DURING AND AFTER THE SHORTAGE
CHARACTERIZING DEMAND DURING THE SHORTAGE
CHAPTER 6 VULNERABILITIES AND RECOMMENDATIONS
CONCENTRATION OF PRODUCTION AND SALES
GOVERNMENT’S MANAGEMENT OF ADVERSE CONSUMER IMPACT
ALIGNMENT WITH ONGOING FEDERAL GOVERNMENT EFFORTS
VALUE OF USING A VULNERABILITIES FRAMEWORK
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 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 K COMMITTEE RECOMMENDATIONS TO HHS, USDA, AND CONGRESS BY VULNERABILITY CLASSIFICATION
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Preface
The infant formula shortage in 2022 was considered by the U.S. Food and Drug Administration (FDA) to be a “perfect storm” in that the supply chain challenges associated with the COVID-19 pandemic, an infant formula recall, and a plant shutdown all contributed to creating a shortage in the supply of infant formula in the United States. The shortage required an extraordinary response from many branches of government and the private sector to address the needs of infants and other vulnerable populations. The shortage and response to it have also illustrated the need for reforms to reduce the risk of triggering future shortages and put safeguards in place to expeditiously mitigate the effect of any future shocks to the supply chain for these critical foods. In this context, the committee focused on the vulnerabilities that were revealed during the shortage, the steps taken by various stakeholders to remediate the crisis as it evolved, and the changes that were made to the system for managing the production and supply chain of infant formula with the goal of identifying areas that still must be addressed in the “supply, market competition, and regulation of infant formula in the United States.”
Because of the response to the shortage, infant formula and medical foods (as defined in section 5(b)(3) of the Orphan Drug Act) are now designated as critical foods. The response highlighted challenges in the FDA organizational structure contributing to FDA undergoing a major reorganization of the Human Foods Program. The U.S. Department of Agriculture (USDA) has new authorities to manage access to formula for participants in the Special Supplemental Nutrition Program for Women,
Infants, and Children (WIC). FDA has commissioned an additional National Academies of Sciences, Engineering, and Medicine (the National Academies) study to examine the quality factors used for infant formula notifications, and the U.S. Department of Health and Human Services (HHS) has commissioned a National Academies study on breastfeeding. A study by the National Advisory Committee on Microbiological Criteria for Foods Subcommittee on Cronobacter spp. has also been commissioned by FDA. Congress directed FDA to use the current report by the Committee on Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States to update the Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market (March 2023), and our report addresses many of the issues identified in that report, including understanding how breastfeeding relates to the analysis of vulnerabilities in the infant formula market. In addition, government as a whole is focusing on vulnerabilities within the supply chain and the need to improve preparedness, resiliency and risk management. The committee applauds these actions and hope that our report contributes to building the needed safeguards.
The committee was frequently told, in public session and via written input, that the government and industry responses were ultimately effective, but they simply took too long to be initiated. By capturing what was learned from the 2022 shortage and investing in steps to address vulnerabilities, as well as coordinated planning, government and industry can be better prepared to respond quickly in the future and mitigate the impact of a shortage, no matter what the cause. In this context, several of our recommendations focus on how the new authorities granted to FDA and USDA are being implemented. However, the committee also identified roots of some of the challenges in the pre-shortage framework mechanisms for regulating, producing, and distributing these products prior to the shortage that need to be addressed to improve overall preparedness and response capabilities for the infant formula sector.
The committee received valuable input from the public sessions and written comments. These sessions provided the committee with insights on the many facets that are important for understanding the production, use, and regulation of these products as well as the needs of caregivers who use these products. The committee is grateful for the openness and information these participants provided.
The committee also acknowledges that while this report was in review, FDA announced the approval of the reorganization to establish the Human Foods Program that is referenced in the report as a proposed reorganization. The committee anticipates that this program will have an important role in the committee’s recommendations directed at FDA.
As chair and vice chair of this committee, we are grateful for the commitment and dedication of committee members (see Appendix A) to gather and analyze relevant information and to respect the different areas of expertise among committee members. Consequently, the committee has developed a report that reflects the analysis and insights in the findings, conclusions, and recommendations in a very demanding timeline.
The committee had outstanding support for our work from the National Academies’ study staff, including Katherine Delaney and Patricia Cuff (co-directors for the study), Jennifer Stephenson (research associate), Melanie Arthur (senior program assistant); in addition, we appreciate the assistance of Melissa Maitin-Shepard and Michelle DelFavero (science writers) in preparing the final report. FDA served as the sponsor of the study.
Barbara O. Schneeman, Chair
Ravi M. Anupindi, Vice Chair
Committee on Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States
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Acronyms and Abbreviations
| AAP | American Academy of Pediatrics |
| ABFA | Access to Baby Formula Act of 2022 |
| AI | adequate intake |
| ARA | arachidonic acid |
| ASPR | Administration for Strategic Preparedness and Response |
| CACFP | Child and Adult Care Food Program |
| CAC | Codex Alimentarius Commission |
| Caco-2 | colorectal adenocarcinoma cell |
| CDC | Centers for Disease Control and Prevention |
| CFR | Code of Federal Regulations |
| CFSAN | Center for Food Safety and Applied Nutrition |
| CMS | Centers for Medicare & Medicaid Services |
| CODEX | Codex Alimentarius |
| CRS | Congressional Research Service |
| CSTE | Council of State and Territorial Epidemiologists |
| DHA | docosahexaenoic acid |
| DOC | U.S. Department of Commerce |
| DoD | U.S. Department of Defense |
| EBT | electronic benefit transfer |
| ERS | Economic Research Service |
| FAO | Food and Agriculture Organization |
| FCN | Food Contact Substance Notification |
| FDA | Food and Drug Administration |
| FDCA | Food, Drug, and Cosmetic Act |
| FDORA | Food and Drug Omnibus Reform Act of 2022 |
| FEMA | Federal Emergency Management Agency |
| FNS | Food and Nutrition Service |
| FOS | fructooligosaccharides |
| FPG | Federal Poverty Guidelines |
| FPL | federal poverty level |
| FSANZ | Food Standards Australia New Zealand |
| FSMA | Food Safety Modernization Act |
| FTC | Federal Trade Commission |
| GAO | Government Accountability Office |
| GOS | galactooligosaccharides |
| GPO | group purchasing organization |
| GRAS | Generally Recognized as Safe |
| HHS | U.S. Department of Health and Human Services |
| HMO | human milk oligosaccharide |
| HS | Harmonized System Classification |
| ITO | Indian tribal organization |
| MFGM | milk fat globule membrane |
| NLEA | Nutrition Labeling and Education Act |
| NTM | Non-tariff measure |
| OECD | Organisation for Economic Co-operation and Development |
| OSA | on-shelf availability |
| PER | protein efficiency ratio |
| PKU | phenylketonuria |
| RBMJ | Reckitt Benckiser-Meade Johnson |
| RIA | regulatory impact analysis |
| RRMP | redundancy risk management plan |
| RTF | ready to feed |
| SNAP | Supplemental Nutrition Assistance Program |
| STR | Special Trade Representative |
| TANF | Temporary Assistance for Needy Families |
| UPC | Universal Product Code |
| USDA | United States Department of Agriculture |
| USITC | U.S. International Trade Commission |
| USTR | Office of the United States Trade Representative |
| WHA | World Health Assembly |
| WHO | World Health Organization |
| WIC | Special Supplemental Nutrition Program for Women, Infants, and Children |
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Glossary
Brand—A type of infant formula made by a particular manufacturer and sold under a particular name.
Breast milk—Human milk produced by the breast that is inclusive of mother’s own milk, parent milk, and breast/chest milk.
Breastfeeding—The act of feeding breast milk to an infant that is inclusive of chest feeding.
Buffers—Policies or practices that mitigate the impact of a supply disruption.
Distributors—Intermediaries in the supply chain that move infant formula product from manufacturers to the point of sale (e.g., a store) or point of administration (e.g., a hospital).
Exempt Infant Formula—An infant formula that is exempt from certain federal requirements (e.g., nutrients, labeling) and is for use by infants who have inborn errors of metabolism or low birth weight, or who otherwise have unusual medical or dietary problems.
Hospitals—Non-retail vendors that administer and provide infant formula directly to infants.
Manufacturer—A company that produces infant formula and includes manufacturers of finished infant formula products and manufacturers of upstream supply chain products.
Non-exempt Infant Formula—Infant formula that meets specific federal nutrient requirements and is intended for use by healthy, term infants.
Potentiators—Factors that exacerbate the shock to the system, either by affecting more people or by worsening the shock for those affected.
Redundancy Risk Management Plan—As defined by FDA using language from the U.S. Code “a redundancy risk management plan identifies and evaluates risks to the supply of the food, as applicable, for each establishment in which such food is manufactured” and “may identify mechanisms by which the manufacturer would mitigate the impacts of a supply disruption.”
Retailer—A person, shop, or business that sells infant formula to include both brick-and-mortar retailers and online retailers.
Triggers—Events or actions that disrupt the supply of a key ingredient or infant formula.
Vendors—Retailers and other entities, such as hospitals, that provide infant formula directly to consumers.
