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Operation Stork Speed and the Future of Infant Nutrition
Earlier this year, the Department of Health and Human Services announced Operation Stork Speed (OSS), a federal initiative aimed at strengthening and improving the infant formula industry. As part of that effort, the Food and Drug Administration issued a Request for Information (RFI), ahead of what will be the first comprehensive review of formula standards in nearly 30 years.
Improving infant formula is crucial for the first 1,000 days, essential for brain development, metabolic programming, and microbiome health. However, current standards only evaluate formula based on growth and safety, limiting innovation and new ingredient inclusion without considering potential benefits. There is a need to address disparities in nutritional quality between breast milk and formula.
As a Pediatrician and Neonatologist, I have been focused on infant nutrition and improving outcomes for formula-fed infants. The current regulatory landscape poses barriers to innovation, but advancements in breast milk science and technology offer new possibilities. We are at a pivotal moment for the future of infant nutrition.
Key Opportunities for Regulatory Framework Evolution:
1. Prioritize Functional Benefits and Robust Clinical Research
Breast milk is a functional food, and formula should reflect this by including ingredients with demonstrated benefits beyond growth. Clinical research should focus on broader developmental outcomes to ensure safety and efficacy.
2. Emphasize Nutrient Quality Over Quantity, Starting with Protein
Protein quality plays a critical role in long-term health, and formula standards should prioritize high-quality proteins that mirror breast milk composition to reduce metabolic risk.
3. Evolve the Review Process to Accelerate Innovation
The FDA should update its nutrient review cycle to align with emerging science and global frameworks, supporting innovation and recognizing ingredients with proven benefits.
With advancements in science and a better understanding of early nutrition, now is the time to transform infant nutrition for generations to come.
Devon Kuehn, M.D. is the Chief Medical Officer and Chief Scientific Officer at ByHeart, an infant nutrition company.