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Pediatric Formulas: An Update
Aamer Imdad1, Rida Sherwani2, Kellie Wall3
1Division of Gastroenterology, Hepatology, Pancreatology, and Nutrition, Department of Pediatrics, Stead Family Children's Hospital, University of Iowa, Iowa City, IA.
Insights
US families sought alternatives during infant formula shortages. European formulas, while often adequate, differ in composition and preparation from US standards, requiring careful pediatrician and family awareness.
Area of Science:
- Nutritional Science
- Pediatric Nutrition
- Food Regulation
Background:
- US experienced infant formula shortages due to supply chain disruptions and contamination.
- Families sought alternative formulas, including imported European options.
- Differences exist between US and European infant formulas.
Purpose of the Study:
- To inform pediatricians and families about differences between US and European infant formulas.
- To guide the appropriate use and preparation of imported formulas.
- To highlight considerations for specialized pediatric formulas.
Main Methods:
- Comparative analysis of European and US infant formula regulations and composition.
- Review of nutritional adequacy and preparation guidelines for various formula types.
- Examination of pediatric formula categories and non-formula milk alternatives.
Main Results:
- European infant formulas vary from US-regulated ones in primary source, age appropriateness, mixing, labeling, and nutrient content.
- Most European formulas are nutritionally adequate but require informed use.
- Pediatric formulas (polymeric, hydrolyzed, elemental, blenderized) and plant-based drinks show significant compositional variability and may not be nutritionally complete.
Conclusions:
- Pediatricians and families must understand European formula differences for safe infant feeding.
- Older infant formulas and non-formula milk drinks are not suitable for children requiring specialized liquid nutrition.
- FDA regulation of pediatric formulas beyond infant stage is limited, necessitating careful product selection.
Abstract:
The recent shortage of pediatric formulas in the United States, caused by supply chain issues and contamination of formula products in 1 of the major manufacturing plants, led many families to seek an alternate formula for their children. The Food and Drug Administration (FDA) allowed import of infant formulas from selected European and non-European countries. The European infant formulas differ from those produced in the United States regarding the primary source of the formula, age category, mixing instructions, labeling requirements, and formula composition in terms of macronutrients and micronutrients. Although most European infant formulas are nutritionally adequate, pediatricians and families need to be aware of the differences between the European and FDA-regulated formulas for their correct use and preparation for infants and young children. Supplementation with cow milk is recommended for children beyond infancy, and older infant formulas are not recommended for otherwise healthy growing children. However, pediatric formulas have been used to support the nutrition needs of children with feeding difficulties, especially those dependent on tube feeding and with certain medical conditions. The FDA does not regulate the production of pediatric formulas beyond infant formula, and significant variations exist in their composition. The pediatric formulas are available as polymeric (intact), hydrolyzed, elemental, or food-based blenderized formulas. The plant-based nonformula (milk) drinks are being used increasingly for children. These products might not be nutritionally complete and should be avoided in infants and children dependent on liquid nutrition.

