Public Input Needed on New Infant Formula Nutrient Rules

The Food and Drug Administration is opening its first in-depth review of infant formula nutrient standards in over 30 years, now inviting public input to shape future guidelines.

Quick Takes

The FDA reviews U.S. infant formula nutrition under “Operation Stork Speed.”
Public feedback encouraged for nutrient standards, due by September 11.
Concerns focus on added sugars, arsenic, and lead levels.
FDA aims to align formulas with modern scientific guidelines.

The Need for an Overhaul

The FDA has initiated a comprehensive review of infant formula nutrient standards, dubbed “Operation Stork Speed.” This move marks the first significant reassessment in decades, addressing the rapidly advancing nutritional science that informs infant health. With the formal release of a Request for Information (RFI), the FDA requests public input on both current nutrient standards and potential additions to optimize infant nutrition.

The FDA is scrutinizing existing formula standards, including 30 mandated nutrients with defined minimum and maximum levels. Feedback is open for 120 days, with responses closing on September 11. This review not only aims to update nutrient levels but also to explore the integration of new essential nutrients more aligned with modern standards.

Big news for infant nutrition!

For the first time in over 25 years, the FDA is launching a full review of the nutrient standards in infant formula.

This means updated science, stricter safety testing (including for heavy metals), and potentially major improvements in how we…

— Mark Hyman, M.D. (@drmarkhyman) May 13, 2025

Addressing Past Issues

Launching this review follows a nationwide formula shortage three years ago caused by a product recall. Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary emphasize safeguarding nutrition as a core commitment. Kennedy notes, “By taking a hard, honest look at the nutrients in infant formula, we’re ensuring that parents have the tools to give their children the best nutrition from the very beginning.” Concerns about added sugars and toxic elements like arsenic and lead in some formulas drive the urgency for change.

Operation Stork Speed promises improved transparency in ingredient declarations, aligning more closely with contemporary science. The FDA’s collaborative approach with formula producers aims to overhaul labeling, contaminant testing, and consumer awareness efforts, especially regarding heavy metals.

The HHS & FDA have just launched Operation Stork Speed.

This initiative is a resolute commitment to ensuring the safety, nutritional integrity, and availability of infant formula for our nation’s families.

RFK will be undertaking a comprehensive review of infant formula…

— Joey Mannarino 🇺🇸 (@JoeyMannarinoUS) May 13, 2025

Industry Cooperation and Future Steps

To achieve meaningful reform, the FDA schedules an expert panel meeting in June as part of the review process. Industry participation is encouraged, as the FDA seeks strategic input from key producers like Abbott Nutrition and Reckitt Benckiser-Mead Johnson. The Infant Nutrition Council of America has affirmed its members’ ongoing compliance with high-quality ingredient standards and willingness to collaborate on this initiative.

Public engagement remains crucial, as detailed via official FDA channels, ensuring broad representation of viewpoints. As the process unfolds, the FDA seeks to integrate these insights into enhanced, science-based guidelines that promise safer and more effective nutrition for the nation’s infants.