HHS & FDA Request Public Comment to Inform Agency’s Infant Formula Nutrient Review

Background 

The Federal Food, Drug, and Cosmetic Act (FFDCA) establishes requirements for the nutrient content of infant formulas.² The statute and implementing regulation prescribe specific nutrients (protein, fat, fatty acids, vitamins, and minerals), maximum levels for each, and for some nutrients a minimum level.  Mandatory nutrients and nutrient levels vary depending on whether the formula is milk or non-milk-based.  The FFDCA also directs the Secretary of HHS to review the table of required nutrients “every 4 years as appropriate” taking into account “any new scientific data or information related to infant formula nutrients, including international infant formula standards.”   

On March 18, 2025, FDA announced a new initiative, Operation Stork Speed, “to enhance its efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.”  Among other things, in Operation Stork Speed the agency committed to undertaking “the first comprehensive update and review of infant formula nutrients since 1998.”   On May 13, 2025, HHS &FDA announced the next steps for the comprehensive review, which include the RFI and a publicly accessible expert panel set to convene in June. 

Request for Information

The RFI includes 6 specific questions.  FDA is seeking information on infant nutrition developments broadly (i.e., new scientific data or information since 1998), as well as on nutrient-specific topics such as whether docosahexaenoic acid and arachidonic acid should be required nutrients. 

Throughout the questions, FDA repeatedly asks for scientific data and references.   FDA’s specific questions follow:

1. 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? 
2. What scientific data or information have 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? 
3. Which existing nutrients required in 21 CFR 107.100 should we review? Please explain your rationale. 
4. 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. 
5. 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.
6. Which nutrients, if any, should we remove from 21 CFR 107.100? Please explain your rationale. 

The request for information provides an opportunity for industry to highlight agency positions that have complicated the ability to innovate in the infant formula space such as the seeming prohibition on the addition of “bioactive ingredients” to infant formulas given agency concerns with the proper safety paradigm for evaluating these ingredients. 

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We will continue to closely monitor developments related to Operation Stork Speed and infant formula regulation generally, including details regarding the publicly accessible expert panel to be convened in June.