FDA Seeks Public Opinion on Proposed Infant Formula Nutrient Updates

The FDA embarks on its first review of infant formula nutrient standards in decades, inviting public input on potentially crucial changes.

Quick Takes

The FDA is reviewing infant formula nutrient standards for the first time in over 30 years.
Public input is requested, with a deadline to submit by September 11.
The initiative aims to update nutrient requirements and introduce new ones.
“Operation Stork Speed” will enhance transparency and labeling for parents.

Historic Review Underway

The FDA is conducting a review of the nutrient standards for infant formula in the United States, marking the first substantial evaluation of its kind since 1998. This effort, part of the “Operation Stork Speed” initiative, aims to evaluate and potentially update the current mandated nutrients to better align with scientific standards. As infant formula often represents the only source of nutrition for infants, ensuring compliance with stringent safety and efficacy criteria is paramount.

Encouraging public participation, the FDA has issued a Request for Information (RFI). Stakeholders, ranging from parents to health professionals, have the opportunity to provide their perspectives on the existing nutrient standards and the potential need for adjustments. The window for submitting feedback closes on September 11, 2025.

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

Goals of the Initiative

This comprehensive review will evaluate whether updates are necessary for the current nutrient mandates and consider the addition of new ones. With concerns previously raised about contaminants such as arsenic and lead, the FDA is committed to reinforcing the safety of infant formula through increased testing for potential toxins.

“Protecting our most vulnerable is not just a moral duty—it is our responsibility. For many children, infant formula is their only source of nutrition. That’s why it’s absolutely crucial to continually assess the nutrition standards and incorporate gold standard science to ensure we are providing the safest, most effective nutrition possible,” said FDA commissioner Dr. Marty Makary.

Furthermore, the FDA plans to enhance transparency by collaborating with manufacturers to improve labeling, ensuring parents have access to clear and accurate information. This aligns with the agency’s mission to foster a robust and informed public health environment.

Yes, we focus on the process of becoming pregnant. But news like this is always worth sharing!

Pro-fertility is pro-family. And higher nutrient standards for baby formula are certainly a step in the right direction!
Ferta promotes health – from conception to birth, and beyond. https://t.co/JhWIsRSXN5

— Ferta (@joinferta) May 14, 2025

Expert Input and Industry Response

An expert panel convening is scheduled in June to discuss these proposed changes and future developments. Amid these discussions, industry giants such as Abbott Nutrition and Reckitt Benckiser-Mead Johnson have declared their support for potential regulatory changes that could enhance infant health outcomes.

The collaborative efforts between the FDA, health professionals, and the formula industry aim to sustain a high standard of nutritional safety. The operation will further scrutinize and test for contaminants while aligning products with the latest scientific findings.