On February 9, 2023, the U.S. Food and Drug Administration (FDA) issued a draft guidance to manufacturers of infant formula and laboratories conducting testing on infant formula to assist in the design, conduct, evaluation, and reporting of Protein Efficiency Ratio (PER) rat bioassy studies.

Quality of protein is one of many factors FDA considers in evaluating new infant formula submissions. Protein quality is important as infant formula is often a sole source of nutrition for infants.

The guidance makes modifications to the PER rat bioassy method from Association of Official Analytical Chemists (AOAC) International. 

Any shareholder comments can be submitted to https://www.regulations.gov by May 11, 2023.  Keller and Heckman will continue to monitor.