Infant Formula Guide

Vulnerable supply chains have made providing reliable consumer access to infant formula an ongoing challenge. USP’s Food Ingredient Standards provide solutions for infant formula manufacturers, ingredient suppliers, testing laboratories, and regulators to help ensure a sustained level of ingredient quality in the face of complex and continuously changing supply chains. USP created the Guide to Food Ingredient Standards and Solutions for the Infant Formula Industry to provide stakeholders with information on standards and solutions available in the Food Chemicals Codex (FCC) and U.S. Pharmacopeia-National Formulary (USP–NF) to support their needs.

In February 2022, a voluntary recall of several lots of infant formula due to potential quality issues, compounded by worldwide shortages caused by the SARS-CoV-2 pandemic, ultimately led to a major nationwide shortage of infant formula. Many of the vulnerabilities that led to the 2022 shortage have yet to be addressed, and infant formula manufacturing capabilities in the U.S. continue to be limited. Consumer groups, government agencies, and policymakers have called for action to strengthen the infant formula supply chain before another shortage occurs. USP has a strong history of working with industry and regulators to improve access to essential products by providing solutions and public standards to address quality issues and manufacturing challenges.

To support all those involved in the infant formula supply chain, USP is pleased to share this Guide. The Guide includes information on relevant FCC and USP–NF monographs, test methods, USP Reference Standards, and FCC Analytical Materials (FAMs) that stakeholders across the infant formula supply chain can use to help verify product quality.

Sign up below to access the Guide and receive updates on USP’s future work in this area.