On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) announced a major step forward in "Operation Stork Speed". The initiative, launched in March 2025, aims to strengthen the safety and nutritional quality of infant formula. As part of this effort, the FDA issued a Request for Information (RFI) to evaluate whether the existing nutrient requirements for infant formula remain scientifically up to date.

Stakeholders, including scientists, manufacturers, and public health professionals, are encouraged to submit comments by September 11, 2025 via Federal eRulemaking Portal.

Background

Currently, infant formula must meet minimum and maximum levels of certain nutrients. While the FDA regularly reviews individual nutrient requirements for infant formula, this will be the first comprehensive review since 1998.

 Required nutrient levels are measured per 100 kilocalories of prepared formula.

Request for Information

Under this review, the FDA is seeking public input on several key questions, including:

1. Whether new scientific data support adjusting the minimum or maximum levels of the 30 currently required nutrients. Especially in light of evolving international standards and clinical evidence;

2. Whether any nutrients should be added (e.g., DHA, ARA) or removed;

3. How potential changes might affect short- and long-term health outcomes in infants.

In addition, the FDA plans to convene a public expert panel in June to further discuss nutrient standards.

Recommended reading

U.S. FDA Launches Operation Stork Speed to Enhance Infant Formula Safety and Quality