FDA seeks expert insights on modernizing infant formula for better safety

The US Health and Human Services (HHS) and the FDA are taking steps to improve infant formula’s safety, reliability, and nutritional adequacy. The agency is seeking public comments on whether current nutrient requirements should be updated based on the latest scientific data.

The move will mark the first comprehensive review since 2008, despite the FDA regularly reviewing nutrient requirements for infant formula.

“Operation Stork Speed brings radical transparency to ingredients in infant formula and puts science front and center,” says HHS Secretary Robert F. Kennedy, Jr. The initiative was launched in March.

“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.”

Comments open for 120 days

The FDA launched the Request for Information to learn about existing nutritional requirements, including international data.

It says it welcomes data suggesting changes to existing minimum or maximum levels, including new nutrients and information about how the changes might improve health outcomes. Stakeholders have 120 days to submit responses.

“Protecting our most vulnerable is not just a moral duty—it is our responsibility, says FDA Commissioner Martin Makary. “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 FDA says it is increasing testing for heavy metals and contaminants in infant formula and children’s food. It asks companies to work together on ensuring transparency and improving labels.

Last month, Nutrition Insight spoke to experts warning that the FDA is failing to protect infant formula safety, citing inaction on toxic contaminants, nano ingredients, and regulatory conflicts of interest. We spoke to the Center for Food Safety and the Alliance for Natural Health to unpack concerns and solutions as the FDA undergoes staff cuts.

“The new FDA administrator for food safety, Kyle Diamantas, used to work for Abbott Laboratories, fighting against parents of infants made ill from pathogens in Abbott’s formula,” said Jaydee Hanson, policy director at the Center for Food Safety.