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FDA Announces New Infant Formula Initiatives That Impact Manufacturers

In collaboration with the Department of Human Health and Services (HHS), the FDA has announced new infant formula initiatives that will require producers to take additional steps.

FDA headquarters
There are two initiatives that will most obviously impact infant formula manufacturers.
Sara Silbiger via Getty Images

The FDA announced new infant formula initiatives including the first comprehensive nutrient review since 1998, increased testing for heavy metals and contaminants, and enhanced transparency requirements for manufacturers.

  • FDA issuing Request for Information to begin first major nutrient review of infant formula since 1998
  • Increased testing requirements for heavy metals and contaminants in infant formula and children's foods
  • Manufacturers encouraged to work with FDA on transparency and clearer labeling standards
  • FDA collaborating with National Institutes of Health on research gaps regarding long-term health outcomes from formula feeding
  • Initiatives designed to ensure quality, safety, and resilience of domestic infant formula supply

Safety and quality of infant formula continues to be a priority for regulatory agencies, and a joint effort between the FDA and HHS is ensuring manufacturers make products that fit high standards.

The FDA is announcing a set of actions and initiatives for formula that revolve around a nutrient review process and increased testing for heavy metals and other contaminants, the agency outlined in a March 18 press release.

The agency plans to do the following:

  • Start 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.
  • Increase testing for heavy metals and other contaminants in infant formula and other foods children consume.
  • Extend the personal importation policy.
  • Encourage companies to work with the FDA on any questions regarding increased transparency and clearer labeling.
  • Communicate regularly with consumers and industry stakeholders as significant developments occur to ensure transparency, including information regarding nutrients and health outcomes.
  • Collaborate 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.   

Two initiatives that could stand out most for infant formula producers are increased testing requirements and encouragement of companies to communicate with the FDA on transparency and labeling.The FDA says the steps are designed to assure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply. 

In Feb. 2024, the AP reported that Jim Jones, former FDA deputy commissioner for foods, cited the firing of nearly 90 staffers in his division, per a copy of his resignation letter. The FDA has reportedly gone through a restructuring to allow it to better oversee products like infant t formula and baby food.

Despite the seeming fluctuation in staffing, the FDA says it remains committed to infant formula safety and nutritional quality and is taking actions to ensure the U.S. formula supply maintains exceptional standards.  

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