February 9, 2023

The U.S. Food and Drug Administration (FDA) has issued draft guidance to manufacturers of infant formula and laboratories conducting testing on infant formula to help them in the design, conduct, evaluation, and reporting of Protein Efficiency Ratio (PER) rat bioassay studies. Sufficient biological quality of protein is one of many factors FDA considers in evaluating a new infant formula submission. Protein quality is important as infant formula is often a sole source of nutrition, including protein, for infants.

The draft guidance details modifications to the PER rat bioassay method from AOAC International (formerly the Association of Official Analytical Chemists) that are appropriate to demonstrate to the FDA that a new infant formula meets the quality factor of sufficient biological quality of protein. This draft guidance is one of the steps the FDA is taking to assist manufacturers, including those who would be new entrants to the U.S. infant formula market, by providing information that firms can consider when developing a new infant formula submission for FDA review. Providing information to assist manufacturers with their new infant formula submissions supports a more resilient infant formula industry.

Submit electronic comments to https://www.regulations.gov to docket number FDA-2022-D-2424. Written comments should be submitted to:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852.
All comments should be identified with the docket number FDA-2022-D-2424.

For Additional Information

• Draft Guidance: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein
• Federal Register Notice
• Final rule: Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula
• Infant Formula Guidance Documents & Regulatory Information