It’s a Bird, It’s a Plane, It’s an UPDATE on Operation Stork Speed

Operation Stork Speed is a go!

On March 18, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster the availability and safety of infant formula in the United States (see our previous blog post here).

The March announcement outlined six key actions underlying Operation Stork Speed, including the launch of the first comprehensive review of infant formula nutrients (see 21 C.F.R. § 107.100) since 1998.  HHS/FDA explained that such a review would help update the nutrient requirements for infant formulas, ensuring they meet the evolving needs of healthy, full-term infants.

Approximately two months later, HHS/FDA made good on their pledge.  On May 13, 2025, HHS/FDA published in the Federal Register, as well as via an FDA news release, a request for information and data to initiate the nutrient review process for infant formula.  The agency intends to use the collected information to determine what actions, if any, should be taken to update the nutrient requirements.  Purportedly, this review aims to ensure that infant formulas continue to meet the nutritional needs of infants and reflect the latest scientific research.

Specifically, FDA is requesting comments on the below 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 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?
• Which existing nutrients required in 21 C.F.R. § 107.100 should we review? Please explain your rationale.
• For the nutrients required in 21 C.F.R. § 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 C.F.R. § 107.100? Please explain your rationale.
• Which nutrients, if any, should we remove from 21 C.F.R. § 107.100? Please explain your rationale.

Any interested parties should submit comments within 120 days of the Federal Register publication.

In his remarks at the Food Drug Law Institute’s Annual Conference last week, Commissioner Makary noted that FDA plans to convene an expert panel in June as part of Operation Stork Speed, but the Agency has not yet formally announced those plans.  Commissioner Makary also acknowledged some consumers’ desire for infant formulas free of certain ingredients such as seed oils.  It is not yet clear how FDA plans to address that issue.  We will continue to monitor Operation Stork Speed’s progress and report on any further developments.