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FDA Launches Comprehensive Review of Infant Formula Under "Operation Stork Speed"

The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) have jointly announced a nationwide initiative, titled Operation Stork Speed, to conduct a comprehensive review of the nutritional standards and safety of infant formula products available in the market.


This marks the first full-scale review of infant formula requirements since 1998. While individual nutrient standards have been periodically assessed, the new initiative aims to reevaluate the broader framework in light of recent scientific advancements and international research.

As part of Operation Stork Speed, the FDA has issued a Request for Information (RFI) seeking public input on whether existing nutrient requirements remain adequate or need to be revised. The agency is especially interested in comments concerning the current minimum and maximum nutrient levels, suggestions for including new nutrients, and data supporting improved health outcomes through potential changes. Comments can be submitted electronically or in writing until September 11, 2025.

In addition to nutritional review, the FDA is expanding its safety protocols. New measures include more rigorous testing of infant formula for heavy metals and other contaminants, an issue that has drawn increasing scrutiny in recent years. The agency also plans to encourage manufacturers to enhance transparency by improving product labeling and ingredient disclosure.

“Protecting our most vulnerable is not just a moral duty — it is our responsibility,” said FDA Commissioner Dr. Martin A. Makary in a statement. “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.”

To support this effort, the FDA will convene a public expert panel in June 2025. The panel will bring together scientists, health professionals, and other stakeholders to provide additional guidance and insight into updating regulatory standards.

Operation Stork Speed is part of a broader effort by federal health agencies to ensure the safety, nutritional adequacy, and transparency of food products designed for infants. More information about the RFI and the public panel can be accessed via the FDA’s official website.

The initiative follows recent industry and public concerns about the quality and labeling of infant formula, underscoring the need for updated standards that reflect both current science and consumer expectations.


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