Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States (2024)
Chapter: Appendix H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category
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Appendix G: Description of the International Code of Marketing of Breast-Milk Substitutes
Appendix H
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Suggested Citation:
"Appendix H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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 H
Exempt Infant Formulas Marketed in the United States by Manufacturer and Category
This appendix table compares exempt infant formulas across manufacturers and by category.
Suggested Citation:
"Appendix H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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 H-1 Exempt Infant Formulas Marketed in the United States by Manufacturer and Category
| Manufacturer | Infant Formula Category | |||||
|---|---|---|---|---|---|---|
| Metabolic | Premature | Extensively Hydrolyzed Protein | Amino-Acid Based | Fortifiers | Miscellaneous | |
| Abbott | Cyclinex-1 Glutarex-1 Hominex-1 I-Valex-1 Ketonex-1 Phenex-1 Propimex-1 Tyrex-1 |
Similac Special Care 20 Cal w/ Iron Similac Special Care 24 Cal w/ Iron Similac Special Care 24 Cal High Protein Similac Special Care 30 Cal w/ Iron Similac NeoSure |
Similac Alimentum | EleCare with DHA and ARA | Liquid Protein Fortifier Similac Human Milk Fortifier Similac Extensively Hydrolyzed Protein Concentrated Liquid Similac Human Milk Fortifier Concentrated Liquid |
Calcilo XD Pro-Phree ProViMin RCF No Added Carbohydrate Soy Infant Formula Base Similac for Diarrhea Similac PM 60/40 |
Suggested Citation:
"Appendix H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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.
| Manufacturer | Infant Formula Category | |||||
|---|---|---|---|---|---|---|
| Metabolic | Premature | Extensively Hydrolyzed Protein | Amino-Acid Based | Fortifiers | Miscellaneous | |
| Mead Johnson Nutritionals, Bristol-Myers Squibb | Phenyl Free 1 BCAD 1 GA HCY 1 LMD OA 1 TYROS 1 WND 1 |
Enfamil Premature w/Iron 20 Calorie Enfamil Premature w/Iron 24 Calorie Enfamil NeuroPro EnfaCare Enfamil Premature High Protein 24 Calorie Enfamil Premature 30 Calorie |
Enfamil Nutramigen Pregestimil 20 Calorie Pregestimil 24 Calorie Nutramigen with Enflora LGG Nutramigen Toddler with Enflora LGG |
PurAmino | N/A | 3232A Enfamil Human Milk Fortifier Acidified Liquid Enfamil Human Milk Fortifier Powder Enfaport |
| Nestlé Infant Nutrition | N/A | N/A | Gerber Extensive HA | Alfamino | N/A | N/A |
| PBM Nutritionals | N/A | 22 cal/oz milk-based infant formula with DHA and ARA for conditions such as prematurity & low birth weightb | Extensively Hydrolyzed Casein-Based infant formula with ARA, DHA, and probioticc | N/A | N/A | N/A |
Suggested Citation:
"Appendix H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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.
| Manufacturer | Infant Formula Category | |||||
|---|---|---|---|---|---|---|
| Metabolic | Premature | Extensively Hydrolyzed Protein | Amino-Acid Based | Fortifiers | Miscellaneous | |
| Prolacta Biosciences, Inc. | N/A | Prolact RTF 24 Human Milk-Based Premature Infant Formula Prolact RTF 26 Human Milk-Based Premature Infant Formula Prolact RTF 28 Human Milk-Based Premature Infant Formula |
N/A | N/A | Prolact Plus Human Milk Fortifiers (+4, +6, +8, and +10) Prolact CR Human Milk Caloric Fortifier |
N/A |
Suggested Citation:
"Appendix H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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.
| Manufacturer | Infant Formula Category | |||||
|---|---|---|---|---|---|---|
| Metabolic | Premature | Extensively Hydrolyzed Protein | Amino-Acid Based | Fortifiers | Miscellaneous | |
| SHS International Limiteda | MSUD Anamix Early Years IVA Anamix Early Years GA1 Anamix Early Years HCU Anamix Early Years MMA/PA Anamix Early Years PKU Periflex Early Years Tyr Anamix Early Years SOD Anamix Early Years |
N/A | N/A | Neocate Infant w/DHA and ARA Neocate Syneo Infant w/DHA and ARA |
N/A | N/A |
NOTES: ARA = arachidonic acid; DHA = docosahexaenoic acid.
a Nutricia North America is listed on the product labels. Nutricia North America is the distribution company and brand name for the products manufactured by SHS International in the United Kingdom.
b Sold under private labels.
c Sold under private labels.
SOURCE: FDA, 2019.
REFERENCE
FDA (U.S. Food and Drug Administration). 2019. Exempt infant formulas marketed in the United States by manufacturer and category. https://www.fda.gov/food/infant-formulaguidance-documents-regulatory-information/exempt-infant-formulas-marketedunited-states-manufacturer-and-category (accessed March 25, 2024).
Suggested Citation:
"Appendix H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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 H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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 H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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 H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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 H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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 H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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 H: Exempt Infant Formulas Marketed in the United States by Manufacturer and Category." 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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