FDA Launches Operation Stork Speed To Review Infant Formulas

(RTTNews) - The U.S. Food and Drug Administration, along with the U.S. Department of Health and Human Services or HHS, launched an initiative to expand options for safe, reliable, and nutritious infant formula, the sole source of nutrition for infants as an alternative to human milk.

Under the leadership of U.S. Health Secretary Robert F. Kennedy Jr., the initiative, named "Operation Stork Speed," would focus on infant formula through a set of actions to improve the domestic infant formula supply. The health agencies expect the initiative to enhance the quality, safety, nutritional adequacy, and resilience of infant formulas.

The news comes amid increased concerns about the safety and availability of nutritionally adequate formula products for the most vulnerable individuals, as many infants in the U.S. rely on infant formula for some or all of their nutrition.

The FDA, which regulates the production of infant formulas, said the plans include beginning the nutrient review process and increasing testing for heavy metals and other contaminants. The agency is also asking companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients.

HHS Secretary Kennedy said, "The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them. Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again."

As per the statement, the agency, by issuing a Request for Information, is starting the nutrient review required by law in the coming months. It would be the first comprehensive update and review of infant formula nutrients by the FDA since 1998.

The FDA is increasing testing for heavy metals and other contaminants in infant formula and other foods children consume. Further, the actions also include extending the personal importation policy; encouraging companies to work with the FDA on any questions regarding increased transparency and clearer labeling; and communicating regularly with consumers and industry stakeholders as significant developments occur to ensure transparency, including information regarding nutrients and health outcomes.

The health regulator will also 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.

In January, the FDA had released the Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market. It outlined long-term actions to improve information-sharing across all stakeholder groups, as well as actions taken since 2023, to help protect the integrity of the infant formula supply chain.

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