FDA issues Request for Information on infant formula

The FDA is seeking public input on Operation Stork Speed, a review of and effort to improve the quality of infant formula.

Health and Human Services Secretary Robert F. Kennedy Jr. says the comments will help the Food and Drug Administration with its work to increase transparency to the science behind infant formula, and it’s part of his mission to Make America Healthy Again.

“Every child deserves a healthy start. By taking a hard, honest look at the nutrients in infant formula, we’re ensuring that parents have the tools to give their children the best nutrition from the very beginning,” Kennedy said in the announcement about the next steps in Operation Stork Speed.

Operation Stork Speed is an initiative launched in March to ensure the safety, reliability, and nutritional adequacy of infant formula. It comes after a 2021-22 deadly outbreak of cronobacter infections in babies who were fed formula produced by Abbott Nutrition. The outbreak lead to a massive recall of such brands as Similac and Enfamil that caused a severe shortage of infant formula in the United States.

The FDA’s comment period, issued as a Request for Information (RFI), marks the beginning of the first regularly review of infant formula since 1998.  

Martin Makary, FDA commissioner, said the agency has a moral duty to review infant formula.

“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,” Makary said.

Through the RFI, the FDA is seeking input to help determine whether existing nutrient requirements should be revised based on the latest scientific data, including international research. The agency is also seeking information about data on potential adjustments to existing minimum or maximum levels, recommendations for additional nutrients to consider, and how such changes may improve health outcomes.  

The public and industry will have 90 days to submit comments. Further information on how to submit a comment can be found here. As part of the initiative, the FDA will convene a public roundtable on June 3. To register, email publicengagement@fda.hhs.gov.

In addition to the RFI, the FDA is increasing testing for heavy metals and other contaminants in infant formula and other food consumed by children. The agency is also encouraging companies to work with the FDA on enhancing transparency and improving labeling clarity.

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