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 (FDA) 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 essential, given its role in the first 1,000 days – a window critical for shaping brain development, metabolic programming, and microbiome health. But today’s standards evaluate formula based only on its ability to support growth and ensure safety, limiting innovation and the inclusion of new ingredients due to theoretical risk, without equal consideration for potential benefit. And while the benchmarks of growth and safety are necessary, they aren’t addressing the disparities in nutritional quality and potential to drive functional outcomes between breast milk and infant formula.
Throughout my career as a Pediatrician and Neonatologist I’ve been focused on infant nutrition, motivated by the goal of improving outcomes for formula-fed infants. Over the last five years, as the Chief Medical Officer and Chief Scientific Officer of ByHeart, a next generation infant nutrition company, I’ve been inspired by the opportunities to improve infant formula that are now possible due to advancements in breast milk science, manufacturing technology, and ingredient innovation. Yet, at the same time, I’ve been continuously frustrated by the barriers to innovation within the current regulatory landscape. That’s why I strongly believe we’re in a pivotal moment for the future of infant nutrition, and one that will redefine infant formula for generations to come.
Operation Stork Speed lays important groundwork around resiliency, accessibility, and safety, and signals a broader commitment to innovation and transparency in infant nutrition. It creates a meaningful opportunity to refine regulations to help all infants reach their full potential. While innovation is possible within the current system, updated standards could accelerate progress by aligning with emerging science and prioritizing functional health and outcomes alongside safety. At ByHeart, we’ve long emphasized –to policymakers, government officials, healthcare professionals, and consumers – three key opportunities to advance the regulatory framework and evolve the nutritional review process to go beyond adequacy and optimize infant health.
1. Prioritize Functional Benefits and Robust Clinical Research, Beyond just Growth
Breast milk is a functional food. Recognizing this, research has shifted from identifying and quantifying its nutrients to understanding their functional impacts. The regulatory framework should reflect this progress by supporting the intentional inclusion of ingredients with demonstrated benefits; focusing on what purposeful addition can unlock. Adopting a “food is health” lens enables innovation that supports both immediate growth and outcomes, and has real potential for combating the development of chronic illnesses such as metabolic syndrome, allergic and atopic diseases, and those linked to microbiome dysbiosis.
Growth is a critical measure of adequacy, but it doesn’t reflect how formula impacts broader developmental outcomes. The FDA should require clinical research that captures a more complete picture of infant health, providing guidance on demonstrating safety and efficacy, supported by well-defined outcomes and standardized methodologies.
2. Emphasize Nutrient Quality Over Quantity, Starting with Protein
Advances in breast milk science have also established that not just the amount, but quality and source of macronutrients – particularly protein – play a critical role in long-term health through metabolic programming. Historically, formulas have relied on higher protein levels using ingredients like skim milk and whey protein concentrate to ensure growth. But studies show reduced-protein formulas made with high-quality, breast milk-aligned proteins can support growth while potentially lowering metabolic risk. OSS is an opportunity to update standards to prioritize protein quality over quantity, considering amino acid profile and functional benefit, and support recognition of novel proteins that better reflect the composition and function of breast milk.
3. Evolve the Review Process to Accelerate Innovation and Improve Outcomes
The FDA should expand the statutory four-year nutrient review cycle to better reflect emerging science, support innovation, and prioritize outcomes, while also re-evaluating how its current Generally Recognized As Safe (GRAS) process can more effectively recognize ingredients with demonstrated benefits. Critically, reviews should assess the functional benefits of new ingredients. Alignment with global frameworks such as the European Food Safety Authority (EFSA) and the U.N. Food and Agriculture Organization’s Codex Alimentarius would help evolve U.S. regulations and promote consistency across markets. Expert panels, similar to those used by EFSA, can guide evaluation of bioactive and novel components, ensuring that regulations keep pace with advances in research and technology and support the inclusion of ingredients that contribute to long-term health.
With science advancing and the impact of early nutrition well understood, now is the time to move forward. If we meet this moment with clarity and commitment, we have the chance to transform the health of our country’s next generation.
Devon Kuehn, M.D. is the Chief Medical Officer and Chief Scientific Officer at ByHeart, an infant nutrition company.
