In its effort to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched Operation Stork Speed. This initiative encompasses a comprehensive array of actions and initiatives dedicated to enhancing infant formula, including the initiation of a nutrient review process and the augmentation of testing for heavy metals and other potential contaminants in infant formula and other foods children consume. Additionally, through this initiative, FDA is committed to actively fostering innovation among manufacturers to develop new infant formulas while also striving to provide clearer insights and transparency for consumers regarding formula ingredients and health outcomes. Further, FDA is extending the personal importation policy and partnering 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."
On May 14, 2025, as part of Operation Stork Speed, FDA and HHS published an official Request for Information (RFI) in the Federal Register. As pledged in the May 13, 2025, FDA News Release, this RFI is part of FDA's review of the nutritional requirements for infant formula, the first comprehensive review (which FDA has referred to as Ref. 1) to occur since 1998. Specifically, this RFI seeks information to assess the necessity of revising nutrient requirements under 21 C.F.R. § 107.100, taking into consideration any new scientific data and information regarding infant formula nutrients, including international standards. The RFI also requests comment on, with detailed explanation, data, and references provided in support where applicable, the following questions:
- What new scientific data or information since the 1998 comprehensive assessment (Ref. 1) 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 have emerged since the 1998 comprehensive assessment (Ref. 1) 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.
Commenters will have until September 11, 2025, to submit responses to Docket No. FDA-2025-N-1134.
Given the continuous regulatory developments regarding infant formula, it is crucial to be prepared for any potential changes or actions that may arise. Buchanan's White Collar Practice Group and Life Sciences Industry Group are poised to assist individuals or entities impacted by these developments.
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