FDA starts review of nutrients in infant formula | Image Credit: Contemporary Pediatrics

The FDA and the US Department of Health and Human Services (HHS) have issued a request for information (RFI) to begin a review process of nutrients for infant formula, the next steps of a plan called "Operation Stork Speed," which aims to expand options for safe and reliable formula.^1,2

According to a press release from the agencies, infant formula must currently meet minimum and maximum levels of certain nutrients. The agencies stated that while the FDA regularly reviews individual nutrient requirements for infant formula, this will be the first comprehensive review since 1988.¹

The plan was first announced on March 18, 2025, and at the time, the agency stated first steps would be a review of nutrients as well as increased testing for heavy metals and other contaminants. In March, the FDA called on formula companies to develop new infant formulas and "clarify opportunities to help inform consumers about formula ingredients."²

"Operation Stork Speed brings radical transparency to ingredients in infant formula and puts science front and center," said Robert F. Kennedy, Jr, secretary, HHS, in a statement. "Every child has a fundamental right to a healthy start. We’re giving parents the truth and the tools to make that happen. You can’t make America healthy again if we don’t fix what nourishes our youngest and most vulnerable Americans.”¹

The agency did not list any specific safety concerns for the currently available formula in the update prior to the comprehensive review.

The FDA is looking for input from the public via the RFI, to "help determine whether existing nutrient requirements should be revised based on the latest scientific data, including international." The federal agency stated it will welcome data on potential adjustments to in-place minimum or maximum nutrient levels as well as recommendations for additional nutrients to consider and potential changes could improve health outcomes. Commenters will have 120 days to submit responses to the agency.

"Protecting our most vulnerable is not just a moral duty—it is our responsibility, said FDA Commissioner Martin A. Makary, MD, MPH. “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."

The agency will convene a publicly accessible expert panel in June, according to the announcement.

FDA's planned steps

Previously, the agencies outlined their intended steps for the Operation Stork Speed plan. They are:

• Starting the nutrient review required by law by issuing a Request for Information in the coming months to start the first comprehensive update and review of infant formula nutrients by the FDA since 1998
• Increasing testing for heavy metals and other contaminants in infant formula and other foods that children consume
• Extending the personal importation policy
• Encouraging companies to work with the FDA on any questions regarding increased transparency and clearer labeling
• Communicating regularly with consumers and industry stakeholders as significant developments occur to ensure transparency, including information regarding nutrients and health outcomes
• Collaborating with the National Institutes of Health and other scientific bodies to address priority scientific research gaps regarding short- and long-term health outcomes associated with formula feeding in infancy and childhood across the lifespan

More formula headlines:

Bobbie launches first USDA organic whole milk infant formula in US

Bobbie Labs has announced the planned launch of Bobbie Organic Whole Milk Formula, which the company bills as the first and only USDA Organic Whole Milk infant formula on the US market.³

Click here for more.

FDA approves Surgifort human milk-based fortifier for term infants after gastroschisis surgery

The FDA has approved the first human milk-based nutritional fortifier indicated for term infants, with the approval of Prolacta Bioscience's Surgifort, according to a press release from the company.⁴

The human, pasteurized fortifier is indicated for term infants at or older than 37 weeks, following corrective surgery for the gastrointestinal disorder, gastroschisis.

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References:

1. HHS, FDA initiate comprehensive review of nutrients in infant formula. FDA. Press release. May 13, 2025. Accessed May 13, 2025. https://content.govdelivery.com/accounts/USFDA/bulletins/3e03056

2. Fitch, J. FDA, HHS announces plan to enhance quality, safety of domestic infant formula. Contemporary Pediatrics. March 18, 2025. Accessed May 13, 2025.

3. Campbell P. Bobbie launches first USDA organic whole milk infant formula in US. Contemporary Pediatrics. March 10, 2025. Accessed May 13, 2025. https://www.contemporarypediatrics.com/view/bobbie-launches-first-usda-organic-whole-milk-infant-formula-in-us

4. Fitch, J. FDA approves Surgifort human milk-based fortifier for term infants after gastroschisis surgery. Contemporary Pediatrics. February 25, 2025. Accessed May 13, 2025. https://www.contemporarypediatrics.com/view/fda-approves-surgifort-human-milk-based-fortifier-term-infants-gastroschisis-surgery