Evidence map›Paper›PMID 41565223›Full record

ReviewAdvances in nutrition (Bethesda, Md.)2026

Food and Drug Administration Expert Panel on Infant Formula "Operation Stork Speed" June 2025: Part 1, Nutrient Considerations.

Steven A Abrams, James Thomas Brenna, Roger Clemens, Valeria C Cohran, Nan Du, Andrea Gilbaugh, Michael I Goran, Analeise Guild, John A Kerner, Thomas B Knudsen and 2 more

Abstract readReview
In one paragraph

Review in Advances in nutrition (Bethesda, Md.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Steven A AbramsDepartment of Pediatrics, Dell Medical School at the University of Texas, Austin, TX, United States. Electronic address: sabrams@austin.utexas.edu.
James Thomas BrennaDepartment of Pediatrics, Dell Medical School at the University of Texas, Austin, TX, United States.
Roger ClemensDepartment of Regulatory and Quality Sciences, University of Southern California Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, Los Angeles, CA, United States.
Valeria C CohranDepartment of Pediatrics, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.
Nan DuDivision of Gastroenterology, Hepatology, and Nutrition, Center for Nutrition, Boston Children's Hospital, Boston, MA, United States.
Andrea GilbaughClinical Nutrition, Stanford Medicine Children's Health, Palo Alto, CA, United States.
Michael I GoranDepartment of Pediatrics, Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.
Analeise GuildGlobal Gastroschisis Foundation, Wake Forest, NC, United States.
John A KernerDivision of Gastroenterology, Hepatology, and Nutrition, Division of Neonatology and Developmental Medicine, Stanford University Medical Center, Palo Alto, CA, United States.
Thomas B KnudsenDepartment of Intelligent Systems Engineering, Indiana University, Bloomington, IN, United States.
Sushma KrishnaDivision of Neonatology, NewYork-Presbyterian-Weill Cornell Medicine, New York, NY, United States.
Timothy SentongoDepartment of Pediatrics, Pritzker School of Medicine, University of Chicago, Chicago, IL, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Operation Stork Speed, launched by the Food and Drug Administration in March 2025, represents a comprehensive initiative to update infant formula regulations that have remained largely unchanged since the 1980s. This expert panel review addresses recommendations for nutrients considering 4 decades of accumulated scientific evidence. Current Food and Drug Administration fatty acid regulations specify only total fat content and minimum linoleic acid requirements, despite substantial international consensus on polyunsaturated fatty acid specifications. Evidence strongly supports establishing maximum linoleic acid concentrations and docosahexaenoic acid and arachidonic acid requirements, reflecting the critical role of omega-3 (ω-3) fatty acids in neurocognitive development and visual acuity. The panel emphasizes that saturated and monounsaturated fatty acids comprise over 80% of human milk fatty acids, while acknowledging recent concerns about seed oils and supporting balanced PUFA formulations. Carbohydrate composition presents significant concerns, as over half of United States formulas contain glucose polymers (e.g., corn syrup solids) despite lactose being the primary carbohydrate energy source in human milk. Observational studies have linked corn syrup-based formulas to multiple potential health risks, including excess weight gain, warranting reconsideration of the value of non-lactose carbohydrate substitutions in formulas for healthy children. Protein content recommendations support decreasing the upper range of allowable intake, aligning with European standards and addressing concerns about excessive protein intake contributing to later obesity risk. Micronutrient evaluation reveals the need to reduce the iron content in routine formulas, consistent with European Food Safety Authority recommendations and emerging safety data, and a need to set upper limits for the concentration of calcium and phosphorus. Overall, infant formula is a healthy product that has been successfully feeding infants for many decades. These comprehensive updates aim to more closely align United States infant formula regulations with current scientific understanding and international standards while supporting optimal infant growth, development, and long-term health outcomes.

Indexed as

Infant FormulaNutrition PolicyDietary FatsFatty AcidsHumansInfantInfant, NewbornInfant Nutritional Physiological PhenomenaMilk, HumanNutritional RequirementsNutritive ValueUnited StatesUnited States Food and Drug AdministrationDietary FatsFatty AcidsDHAinfant formulainfant nutritionironlactoseoperation stork speed

Identifiers

PMID41565223
PMCPMC13100780

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.