The US Food and Drug Administration (FDA) has announced final guidance for manufacturers of infant formula and laboratories conducting testing on infant formula.
The FDA said in a statement released on Thursday that the guidance was created to assist manufacturers and laboratories in designing, conducting, evaluating and reporting on Protein Efficiency Ratio (PER) studies.
Protein is a vital nutrient that supports growth and development in infants.
PER studies are conducted to ensure the quality of protein in infant formula, which often serves as infants' sole source of nutrition.
The FDA said the guidance aims to support the industry, particularly those looking to introduce new infant formulas to the US market, by outlining how to conduct PER studies in accordance with FDA requirements.
These requirements ensure that new infant formulas meet the quality standard for sufficient protein biological quality.
The new document finalises the approach presented in the draft guidance issued in 2023.
The FDA added that the guidance was part of other steps it was taking to support a "more resilient infant formula supply" by providing manufacturers with information to help with their new infant formula submissions to the FDA.
Manufacturers and laboratories are encouraged to review the guidance and may contact the Infant Formula Premarket Review Staff with questions or to request protocol review and feedback before initiating PER studies.