On March 18, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced the launch of Operation Stork Speed “to enhance [FDA’s] efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.” The press release outlines six steps that FDA is taking under Operation Stork Speed (the Operation) to “make sure infant formula products are safe and wholesome…”:
- “[I]ssuing 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 children consume”
- “Extending the personal importation policy,” which allows individuals to import certain products for their personal use that would normally not be permitted to be marketed in the U.S.”
- “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” and
- “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.”
Secretary Kennedy characterized the Operation as “critical to our pursuit to Make America Healthy Again.”
Consumer Reports (CR) notes that Operation Stork Speed was announced one day after CR shared test results with FDA indicating the presence of heavy metals and other chemicals in infant formula. CR published its test results on March 18, which it characterized as showing “potentially harmful levels of at least one contaminant” in about half of the 41 infant formulas tested.
We are actively monitoring this program and anticipate enhanced scrutiny of infant formula manufacturers by the federal government, consumers, and the private bar. Please let us know if you have any questions regarding this new initiative and how it may affect you.