Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States (2024)
Chapter: Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification
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Appendix J: Special Supplemental Nutrition Program for Women, Infants, and Children Participants' Experiences During the Formula Shortage
Appendix K
Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
Appendix K
Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification
This appendix categorizes the committee’s recommendations (see Chapter 6) by the agency it is directed to.
Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
TABLE K-1 Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification
| Congress | HHS3 | USDA | |
| RRMP | Recommendation 1: HHS and FDA, including the Office of Critical Foods, should conduct sector-wide risk management planning.2 Recommendation 2: FDA should develop evidence-based RRMP regulatory standards, a process for reviewing RRMPs, and a mechanism for monitoring implementation of the RRMPs.1,2 |
Recommendation 3: USDA should promulgate regulations requiring an infant formula manufacturer to meet FDA’s expectations with regard to evidence-based redundancy risk management plan standards to be considered a “responsive” bidder under 7 C.F.R. § 246.16a(c)(5).2 | |
| Concentration | Recommendation 4: Congress should provide suitable incentives (e.g. offering tax credits, accelerated depreciation) to encourage all FDA-registered infant formula manufacturers that have met FDA expectations with regard to evidence-based redundancy risk management plan (RRMP) standards to implement the RRMP and modernize manufacturing plants and equipment located in the United States. This modernization should include measures to prevent the spread of possible contaminants from one area of a facility to another. | Recommendation 5: USDA should extend some of the required infant formula contract remedies to emergency periods or supply chain disruptions precipitated by factors other than a recall and facilitate infant formula distribution to WIC-authorized vendors during such disruptions to protect consumers from the effects of a disruption to the WIC contract-holder’s supply.1 | |
Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
| Speedy Recovery | Recommendation 6: Congress should amend the Federal Food, Drug, and Cosmetic Act to require manufacturers of critical foods to give sufficient advanced notice to the Food and Drug Administration when they decide to discontinue a critical food that is likely to lead to a meaningful disruption prior to removing the product from the market temporarily or permanently.2 Recommendation 7: Congress should grant FDA the authority for remote access of records for critical foods. Recommendation 9: Congress should establish a trigger rule to suspend tariffs and tariff-rate quotas automatically on imported infant formula and imported inputs used in the domestic production of infant formula in the event of a meaningful disruption to the market as defined by HHS. |
Recommendation 8: FDA should collect information on nutrient and labeling requirements used by other countries and use this information to develop a database to be updated every 4 years, consistent with FDORA, of the requirements in other countries to facilitate the use of enforcement discretion in case of a shortage. In addition, the information in the database can be used by FDA to evaluate evidence to determine if an update is needed to U.S. regulations.2 Recommendation 10: HHS, including the HHS Supply Chain Coordinator and FDA, should work with the appropriate wholesalers and distributors of infant formula to develop risk management and disaster plans to prepare for a shortage of critical foods. |
Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
| Adverse impact | Recommendation 11: FDA and CDC should work with infant nutrition experts and infant formula manufacturers to jointly develop guidance on how caregivers can substitute infant formula (based on ingredients) and guidance for providers and caregivers on how to feed their infants when no breast milk or safe infant formula is available, to prepare for any future recall or supply interruption.2 Recommendation 12: FDA should maintain a public list of all infant formulas currently marketed and registered in the United States, indexing formula name, whether the formula is exempt or non-exempt, and the registered list of ingredients that appear on the label. Recommendation 14: CMS should issue a rule requiring hospitals that accept Medicaid to have a plan for responding to a meaningful disruption of nutrition support for hospitalized infants.2 |
Recommendation 13: USDA should update the 2021 USDA Guide and requirements regarding state alternative operating procedure plans in 7 C.F.R. § 246.4(a)(30) to include a design of a governance structure for crisis response that articulates all stakeholders that need to be involved, how they should work together, what is expected of them, and how the overall response will be coordinated at the state level. USDA should develop a dashboard to track critical data on the supply and shortages of infant formula at the state or national level. |
Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
NOTES: CDC = Centers for Disease Control and Prevention; CMS = Centers for Medicare & Medicaid Services; FDA = Food and Drug Administration; FDCA = Food Drug and Cosmetic Act; FDORA = Food and Drug Omnibus Reform Act of 2022; HHS = U.S. Department of Health and Human Services; RRMP = redundancy risk management plans; USDA = U.S. Department of Agriculture.
1 Additional information as part of this recommendation can be found in Chapter 6.
2 Recommendation has implementation considerations, which can be found in Chapter 6.
3 CDC, CMS, and FDA are part of HHS, along with many other entities.
Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
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Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
Suggested Citation:
"Appendix K: Committee Recommendations to HHS, USDA, and Congress by Vulnerability Classification." National Academies of Sciences, Engineering, and Medicine. 2024. Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States. Washington, DC: The National Academies Press.
doi: 10.17226/27765.
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