FDA launches effort to review infant formulas

The Food and Drug Administration (FDA) announced a new initiative Tuesday titled “Operation Stork Speed” aimed at reviewing infant formula ingredients and expanding available options.

According to the FDA, the goal of its new initiative is to ensure the “quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.”

In 2022, the U.S. infant formula supply was hampered following the temporary closure of Abbott Nutrition’s Michigan facility due to bacteria contamination. The FDA shut down the facility for months, and a nationwide recall was issued.

“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,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement, calling this action “critical” to his Make America Healthy Again agenda.

The FDA’s response to the 2022 infant formula crisis has been scrutinized, with the Office of Inspector General for the Department of Health and Human Services finding that the agency was dangerously slow in responding to complaints about conditions at the facility. The blowback from this led in part to the FDA reorganizing its structure in 2024.

In its announcement Tuesday, the FDA listed a set of actions it says will support nutritional adequacy and supply of infant formula. These include conducting the “first comprehensive update and review of infant formula nutrients by the FDA since 1998,” increasing testing for heavy metals and extending the personal importation policy.

The agency also said it will be encouraging companies to develop new infant formulas.