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Food and Drug Administration Expert Panel on Infant Formula "Operation Stork Speed" June 2025: Part 2, Regulatory and
Steven A Abrams1, J Thomas Brenna1, Roger Clemens2
1Department of Pediatrics, Dell Medical School at the University of Texas, Austin, TX, United States.
Advances in Nutrition (Bethesda, Md.)
|January 22, 2026
Summary
Operation Stork Speed aims to improve infant formula oversight. The study highlights the need for updated regulations, supply chain transparency, and global safety standard alignment to address formula safety and market access issues.
Area of Science:
- Food Science and Technology
- Public Health Policy
- Regulatory Affairs
Background:
- Recent infant formula shortages and safety concerns prompted Operation Stork Speed.
- Current Food and Drug Administration (FDA) regulations for infant formula are complex and slow market entry.
- Existing pathways like Generally Recognized As Safe (GRAS) have limitations for new ingredient approvals.
Purpose of the Study:
- To analyze the current regulatory landscape for infant formula in the United States.
- To identify challenges in the approval process for new infant formulas and ingredients.
- To assess the risks associated with toxic substances in infant formula and compare US standards to international benchmarks.
Main Methods:
- Review of FDA regulatory processes for infant formula.
- Analysis of GRAS and food additive petition pathways.
- Comparison of US infant formula regulations with those in the EU, Canada, and Australia.
- Examination of safety concerns regarding heavy metals, PFAS, and other toxins in infant formula.
Main Results:
- FDA processes can be slow and complex, hindering new formula market entry.
- The GRAS and food additive pathways require safety data, with food additive petitions needing extensive FDA approval.
- Infant formula may contain toxic substances like heavy metals and PFAS, posing risks to infants.
- The US lacks enforceable limits for these toxins, unlike other major markets.
Conclusions:
- Legislative updates are necessary to modernize infant formula oversight.
- Increased supply chain transparency is crucial for ensuring formula safety and availability.
- Alignment with international safety standards is needed to enhance the US infant formula regulatory environment.
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