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Operation Stork Speed represents an opportunity to reform infant formula clinical trials

Nature Food (2026)Cite this article

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Operation Stork Speed (OSS) is a recent federal initiative in the United States aimed at modernizing oversight of infant formula composition, strengthening the evidence base, improving contaminant testing and ensuring supply chain resilience1. OSS may result in the first comprehensive review of nutrient standards in almost 30 years; however, it remains a declaration of intent rather than binding policy. US infant formula regulations remain largely rooted on the Infant Formula Act of 1980, now codified as the Federal Food, Drug and Cosmetic Act §412 (21 USC §350a) and the Code of Federal Regulations Title 21. This framework specifies quality control, reporting and recall measures and mandates a premarket notification and verification for new infant formulas, including nutrient provisions, demonstration of normal physical growth and sufficient protein quality2. In practice, these requirements rely heavily on manufacturer-submitted evidence, particularly clinical trials assessing growth and tolerance.

The US infant formula landscape changed following COVID-19 and the subsequent formula shortage. In May 2022, the US Food and Drug Administration introduced measures to increase supply-chain resilience, including enforcement discretion that allowed internationally manufactured formulas to enter the US market3. However, §412 was not amended, creating a temporary mismatch between foreign and domestic standards (for example, the European Union requires 20–50 mg per 100 kcal docosahexaenoic acid in all infant formulas). Ultimately, all foreign products were required to transition to the standard US regulatory pathway by mid-2025 (ref. 2).

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References

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Authors and Affiliations

  1. Department for Evidence-based Medicine and Evaluation, Centre for Evidence-Based Health Services Research, University for Continuing Education Krems, Krems, Austria

    Bartosz Helfer

  2. Institute of Psychology, University of Wrocław, Wrocław, Poland

    Bartosz Helfer

  3. Institute of Psychology, University College of Professional Education, Wrocław, Poland

    Katarzyna Henke-Ciążyńska

  4. School of Public Health, Imperial College London, London, UK

    Robert J. Boyle

Authors
  1. Bartosz Helfer
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  2. Katarzyna Henke-Ciążyńska
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  3. Robert J. Boyle
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Corresponding author

Correspondence to Bartosz Helfer.

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Competing interests

R.J.B. declares support from Wiley and the British Society for Allergy and Clinical Immunology for editorial work, from the UK Department of Health and Social Care for expert advisory committee work, from Taus, Cebulash and Landau for expert witness work, from the World Health Organization and the Norwegian Directorate of Health for consultancy and from the European Academy of Allergy and Clinical Immunology for a conference presentation unrelated to the present manuscript. The other authors declare no competing interests.

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Nature Food thanks Dina M. Dimaggio and Anthony Porto for their contribution to the peer review of this work.

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Helfer, B., Henke-Ciążyńska, K. & Boyle, R.J. Operation Stork Speed represents an opportunity to reform infant formula clinical trials. Nat Food (2026). https://doi.org/10.1038/s43016-026-01357-6

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