In a significant step toward ensuring the health of America’s youngest citizens, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced on May 13, 2025, the launch of a comprehensive review of nutrients in infant formula. This initiative, part of the ambitious Operation Stork Speed, marks the first holistic evaluation of infant formula nutrient requirements since 1998. With a focus on transparency, science, and safety, the FDA has issued a Request for Information (RFI) to gather public input on updating these standards, signaling a new era in infant nutrition policy.
What is Operation Stork Speed?
Launched in March 2025, Operation Stork Speed is an HHS and FDA initiative designed to enhance the safety, reliability, and nutritional quality of infant formula. Prompted by a renewed commitment to public health, the program addresses longstanding concerns about the adequacy of current standards and the need for greater transparency in the infant formula industry. As HHS Secretary Robert F. Kennedy, Jr. stated, “Every child has a fundamental right to a healthy start. We’re giving parents the truth and the tools to make that happen.”
The initiative comes at a critical time. Infant formula is often the sole source of nutrition for many babies, making its safety and nutritional profile paramount. Recent concerns about contaminants like heavy metals and outdated nutrient standards have underscored the urgency of this review. Operation Stork Speed aims to modernize regulations, incorporate cutting-edge science, and rebuild parental trust in the products they rely on.
The Nutrient Review: A Game-Changer
The FDA’s RFI kicks off the first comprehensive review of infant formula nutrient requirements in over 25 years. Current regulations, outlined in 21 C.F.R. Part 107, mandate minimum and maximum levels for certain nutrients (e.g., proteins, fats, vitamins, and minerals) to ensure formulas meet infants’ developmental needs. However, these standards have not been systematically updated since 1998, despite advances in nutritional science and international benchmarks.
Through the RFI, the FDA is seeking:
- Scientific data on whether existing nutrient minimums or maximums should be revised.
- Recommendations for additional nutrients to include (e.g., emerging research on omega-3 fatty acids or prebiotics).
- Evidence on how nutrient adjustments could improve health outcomes, such as cognitive development or immune function.
- International perspectives to align U.S. standards with global best practices, like those set by the Codex Alimentarius.
The public has 90 days to submit comments, with details available on the FDA’s website. This open call for input reflects the agency’s commitment to “radical transparency,” as Kennedy emphasized, ensuring parents, researchers, and industry stakeholders have a voice in shaping the future of infant nutrition.
Beyond Nutrients: A Holistic Approach
Operation Stork Speed goes beyond nutrient standards. The FDA is ramping up efforts to:
- Increase testing for heavy metals (e.g., lead, arsenic) and other contaminants in infant formula and children’s foods, addressing concerns raised in recent studies (e.g., a 2023 Environmental Health Perspectives report on heavy metal exposure).
- Enhance labeling clarity to help parents make informed choices, potentially including warnings about contaminants or clearer nutrient breakdowns.
- Encourage industry collaboration to improve manufacturing practices and transparency.
In June 2025, the FDA will convene a publicly accessible expert panel to review RFI responses and discuss next steps. This panel will include nutritionists, pediatricians, and toxicologists, ensuring a multidisciplinary approach to updating standards.
Why This Matters
For many infants, formula is their primary or only source of nutrition during critical developmental windows. Outdated nutrient standards could mean babies miss out on optimal nutrition, while contaminants pose risks to long-term health. FDA Commissioner Martin A. Makary, M.D., M.P.H., underscored this, stating, “Protecting our most vulnerable is not just a moral duty—it is our responsibility.”
The review also responds to broader public health goals. As Kennedy noted, “You can’t Make America Healthy Again if we don’t fix what nourishes our youngest and most vulnerable Americans.” By aligning regulations with modern science, the FDA aims to reduce health disparities, improve developmental outcomes, and restore confidence in a product millions of families rely on.
Challenges and Opportunities
While the initiative has been widely praised, it faces challenges:
- Industry Pushback: Formula manufacturers may resist changes that increase production costs or require reformulation. The FDA’s call for voluntary collaboration aims to mitigate this, but regulatory mandates may be needed.
- Scientific Complexity: Balancing nutrient levels is tricky—too much of a nutrient (e.g., iron) can be as harmful as too little. The expert panel will need to navigate conflicting research and international standards.
- Public Trust: Past formula shortages (e.g., 2022) and contamination scandals have eroded confidence. Transparent communication, like the public expert panel, will be critical to rebuilding trust.
On the flip side, the review offers opportunities:
- Innovation: Updated standards could spur development of formulas with advanced nutrients, like those supporting gut health or brain development.
- Global Leadership: Aligning with or surpassing international standards could position the U.S. as a leader in infant nutrition.
- Parental Empowerment: Clearer labeling and contaminant testing will give parents better tools to choose safe, effective products.
How to Get Involved
The FDA’s 90-day comment period is a chance for parents, healthcare providers, researchers, and advocates to shape the future of infant formula. Comments can be submitted via the FDA’s website here. Key questions to address include:
- Are current nutrient levels (e.g., vitamin D, DHA) optimal based on recent research?
- Should the FDA require testing for emerging contaminants like microplastics?
- How can labeling be improved to help parents navigate formula options?
Consumer inquiries can be directed to 888-INFO-FDA.
Looking Ahead
Operation Stork Speed is a bold step toward ensuring infant formula meets the needs of today’s families.
By prioritizing science, transparency, and safety, HHS and the FDA are addressing a critical public health issue with far-reaching implications. As the nutrient review unfolds and the expert panel convenes, parents can expect a more robust, evidence-based approach to formula regulation—one that puts their children’s health first.
Stay tuned for updates on the RFI responses and the June expert panel. In the meantime, share your thoughts in the comments below or submit them to the FDA. Together, we can help ensure every baby gets the healthy start they deserve.
Author: Barby Ingle
Published by: International Pain Foundation, iPain Blog, Team iPain
Disclaimer: This article is based on the HHS/FDA press release dated May 13, 2025.
