On May 14, as part of Operation Stork Speed (the Operation), the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) to begin its review of infant formula nutrition requirements. FDA’s last comprehensive review of infant formula nutrition occurred in 1998.
In announcing the RFI, U.S. Department of Health and Human Services (HHS) Secretary Kennedy stated that the Operation “brings radical transparency to ingredients in infant formula and puts science front and center….You can’t Make America Healthy Again if we don’t fix what nourishes our youngest and most vulnerable Americans.” We previously wrote about the launch of the Operation here. As we noted in that post, Secretary Kennedy characterized the Operation as “critical to our pursuit to Make America Healthy Again.”
The RFI invites comment on (i.e., answers to) the following six questions:
- What new scientific data or information since the 1998 comprehensive assessment … should we consider regarding nutrient requirements for healthy, full-term infants that are associated with positive short- and/or long-term health outcomes?
- What scientific data or information has emerged since the 1998 comprehensive assessment … regarding nutrient intakes for healthy, full-term infants that are associated with poor short- and/or long-term health outcomes?
- Which existing nutrients required in 21 CFR 107.100 should we review? Please explain your rationale.
- For the nutrients required in 21 CFR 107.100, what, if any, adjustments should be made to existing minimum or maximum levels? For the 20 nutrients with only a minimum level, which, if any, should have a maximum level added? Please explain your rationale. For example, describe how changes might positively impact health outcomes.
- What other nutrients (e.g., docosahexaenoic acid and arachidonic acid) or specifications for nutrients (e.g., ratio of linoleic acid to alpha-linolenic acid), if any, should we consider adding to 21 CFR 107.100? Please explain your rationale.
- Which nutrients, if any, should we remove from 21 CFR 107.100? Please explain your rationale.
Comments should include “references and data, if possible” and are due by September 11, 2025.
Companies in the infant formula space should strongly consider commenting themselves or coordinating with industry groups on comments to ensure that their perspectives are adequately represented. We are ready and able to assist. Please let us know if you have any questions regarding the RFI or the Operation in general.