Evidence map›Paper›PMID 41571233›Full record

ReviewAdvances in nutrition (Bethesda, Md.)2026

Food and Drug Administration Expert Panel on Infant Formula "Operation Stork Speed" June 2025: Part 2, Regulatory and Safety 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
PubMed Full text at PMC Publisher
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, USC Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, Los Angeles, CA, United States.
Valeria C CohranDepartment of Pediatrics, The Ann & Robert H. Lurie Children's Hospital of Chicago, Feinberg School of Medicine, Chicago, IL, United States.
Nan DuCenter for Nutrition, Division of Gastroenterology, Hepatology, and 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 and 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 and 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, New York-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 was launched to modernize infant formula oversight after 2022 shortages and other evidence of supply chain and safety issues. Current Food and Drug Administration (FDA) processes to regulate formulas are at times slow and complex, making it difficult for new formulas to enter the market. One key pathway to adding bioactive substances or other compounds to infant formula is via the generally recognized as safe (GRAS) route. GRAS and food additive pathways require safety data, but food additive petitions require more safety information and cannot be marketed until FDA approval is granted. Concern has been expressed about the safety of the formula related to the possible presence of toxic substances in the formula. Heavy metals, perfluoroalkyl and polyfluoroalkyl substances, and other toxins can be found in formulas, and infants can be at increased risk of effects. United States lacks enforceable limits, unlike the European Union, Canadian, and Australian counterparts. To enhance the regulatory environment for infant formula, legislative updates, supply chain transparency, and alignment with global safety standards are needed.

Indexed as

Food SafetyInfant FormulaUnited States Food and Drug AdministrationFood AdditivesFood ContaminationHumansInfantUnited StatesFood Additivesformula safetygenerally recognized as safeheavy metalsinfant formulainfant nutrition

Identifiers

PMID41571233
PMCPMC13100779

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.