Pediatric Formulas: An Update

Aamer Imdad; Rida Sherwani; Kellie Wall

doi:10.1542/pir.2023-006002

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.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.

Pediatric Formulas: An Update

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