Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—FDA GUIDANCE NOTICES: Protein efficiency ratio rat bioassay studies to demonstrate new infant formula supports quality factor, (May 27, 2026)

By WK Editorial Staff

The guidance finalizes the approach presented in the draft guidance issued in 2023.

The FDA issued a guidance entitled “Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate That a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein” that provides information for manufacturers and contract laboratories that perform PER studies to assist in designing, conducting, evaluating, and reporting PER studies. The guidance explains “appropriate modifications” of AOAC Official Method 960.48 (the AOAC Method) with the aim of supporting industry in successfully conducting PER studies that demonstrate that a new infant formula meets the quality factor of sufficient biological quality of protein when fed as the sole source of nutrition (Notice, 91 Fed. Reg. 30318 (May 22, 2026)).

Dates. The announcement of the guidance is published in the Federal Register on May 22, 2026.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews ClinicalNews FoodNews