FDA Uses Rats to Prove Your Baby Formula Works
Published Date: 5/22/2026
Notice
Summary
The FDA just released new guidance to help baby formula makers prove their products have good-quality protein using special rat studies. This update affects formula manufacturers and labs, making it easier and clearer to show their formulas meet nutrition standards. The guidance is effective now, helping companies avoid costly mistakes and speed up getting new formulas to market.
Analyzed Economic Effects
4 provisions identified: 4 benefits, 0 costs, 0 mixed.
FDA guidance helps formula makers pass PER studies
The FDA published guidance on May 22, 2026 that explains how infant formula manufacturers and contract laboratories should design, conduct, evaluate, and report Protein Efficiency Ratio (PER) rat bioassay studies under AOAC Official Method 960.48 to show a new infant formula meets the quality factor of sufficient biological quality of protein.
Technical rules: diet matching and method changes
The guidance finalizes ‘‘appropriate modifications’’ to AOAC Method 960.48, including recommendations to match compositions of test and reference PER study diets to within 20 percent above or below and to delete a prior recommendation for an optional casein reference group with matched sulfur amino acid concentrations.
Guidance aims to support formula supply resilience
FDA states the guidance will help ensure infant formula products meet regulatory requirements and 'will contribute to ensuring a more resilient infant formula supply.' The guidance was announced on May 22, 2026.
FDA signals future validation and alternatives talk
The guidance notes FDA anticipates future discussions about validation data for PER modifications and 'considering alternative methods besides the PER method,' including non-animal methods.
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