Protein Quality and Growth Monitoring Studies: Quality Factor Requirements for Infant Formula

Formula is often the sole source of nutrition for many infants, making its safety and quality particularly critical. While most food laws and regulations apply to infant formulas, they are also subject to additional requirements and manufacturer regulations for certain quality factors. These include an assessment of protein quality and demonstration that the formula supports normal infant physical growth.

Per the Food and Drug Omnibus Reform Act of 2022, the U.S. Food and Drug Administration asked the National Academies to examine and report on the state of the science regarding methodologies for assessing the biological quality of protein in infant formula and the ability of infant formula to support normal physical growth. The committee's statement of task noted that its analysis should include the examination of current study designs and methods that could demonstrate quality factors have been met. The resulting report presents conclusions, recommendations, and areas of future research to improve standardized procedures for assessing protein quality in infant formula.