Food and Drug Administration Expert Panel on Infant Formula “Operation Stork Speed” June 2025: Part 2, Regulatory and Safety Considerations

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.