FDA Guidance on Protein Quality Studies for New Infant Formula
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FDA makes final guidance available for companies that need to show a new infant formula has protein of sufficient biological quality when it is used as the only source of nutrition. The guidance explains how manufacturers and contract laboratories should design, run, assess, and report Protein Efficiency Ratio rat bioassay studies. The practical effect is clearer expectations for infant formula developers and testing labs. Companies preparing submissions or evidence for new formulas should align their PER study protocols and reports with the FDA’s recommended modifications to the AOAC method.
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Key Changes
- Finalizes FDA guidance on using Protein Efficiency Ratio rat bioassay studies for new infant formula
- Explains recommended modifications to AOAC Official Method 960.48 for infant formula protein-quality testing
- Sets clearer expectations for study design, conduct, evaluation, and reporting by manufacturers and contract laboratories
Obligations
What this law requires
Manufacturers and contract laboratories performing Protein Efficiency Ratio rat bioassay studies for a new infant formula should design, conduct, evaluate, and report the studies in line with FDA’s guidance on appropriate modifications to AOAC Official Method 960.48 when using the study to support sufficient biological quality of protein.
Any person submitting electronic or written comments to the FDA docket is responsible for ensuring the submission does not include confidential information, including medical information, Social Security numbers, confidential business information, or manufacturing-process details that should not be made public.