Beyond the Bottle: How Operation Stork Speed Can Deliver an Infant Formula Revolution

This week, the Food and Drug Administration (FDA) will convene a roundtable of experts on the topic of infant nutrition as part of Operation Stork Speed—an initiative launched by Department of Health and Human Services Secretary Robert F. Kennedy, Jr., focused on the nutritional adequacy, safety, and resilience of the domestic infant formula supply.

This initiative has brought renewed attention to infant nutrition, a category I’ve spent more than a decade working to improve, and one that’s overdue for reform. Many refer to the 2022 formula shortage, which exposed the fragility of a system that millions of families rely on. But that crisis was only the tip of the iceberg. It revealed a systemic failure in how this country approaches this most foundational food. With more than 70% of U.S. babies relying on formula at some point during their first 6 months, the stakes have never been higher.

As agency leaders prepare for the first comprehensive review of infant formula in nearly 30 years, I urge them to consider this: second to breast milk, infant formula is the most critical first food for babies. But the gap between the two is significant, and closing it requires more than removing what doesn’t belong; we must also focus on what should be included. We need an industry that’s grounded in nutrition science, backed by clinical evidence, and committed to closing this nutritional gap.

For too long, the infant nutrition industry has been stagnant, largely controlled by legacy manufacturers with little incentive to evolve. I call this the illusion of the shelf: what looks like choice is often the same decades-old recipe, white-labeled and rebranded. This lack of competition has encouraged speed-to-market over innovation, leaving parents unaware that many “new” formulas are repackaged versions of outdated products. Some will say the current regulatory system works, but anyone who’s navigated the formula aisle knows how quickly science gets buried under marketing. For parents to trust claims, they need to understand which formulas are innovative and supported by clinical evidence.

Formulas should strive to reflect the nutritional and functional complexity of breast milk, but most fall short. We must recognize the difference between counting macronutrients and understanding their quality. That’s why R&D investment should prioritize purposeful addition as much as thoughtful subtraction. Clean alone is not enough.

To be clear, subtraction is critical. For example, using whole milk instead of skim preserves its natural fat content, reducing the need for added oils like soy or palm to meet fat requirements. In short, higher-quality inputs mean fewer workarounds. Taking it a step further, focusing on purposeful additions that support the functional benefits of breast milk—such as using its naturally occurring proteins rather than whey protein concentrate—help bridge the nutritional gap significantly.

However, none of this matters without proof. Clinical trials are the foundation for trust and clarity. Claims should be backed by rigorous clinical trials, not marketing. When parents stand in front of crowded shelves, they don’t just need a list of ingredients; they need evidence.

We need policymakers to create an environment that rewards innovation and holds manufacturers accountable. This requires a multi-pronged approach that addresses both regulatory gaps and market incentives.

Here are three key areas the Administration should consider:

  1. Modernize Nutrient Standards to Reflect Quality, Not Just Quantity: Current regulations focus on nutrient quantity, not quality or bioavailability. We need to assess protein composition, macronutrient quality, and breast milk benchmarking. This means shifting from minimums to optimizing for functional benefits.
  2. Prioritize Clear Scientific and Labeling Standards: Parents deserve to know what they’re feeding their babies. Claims must be supported by robust clinical evidence, and labels must be transparent. No clinical trial, no claim. Stricter enforcement and a willingness to challenge misleading marketing is essential.
  3. Incentivize Innovation, Not Shortcuts: Let’s reward companies that invest in original science, build their own supply chains, and offer traceability. Tax incentives and grants should support those advancing infant nutrition and strengthening domestic production.

As the recent Make America Healthy Again assessment report suggested, many U.S. consumers are looking to Europe for cleaner formulas. But we believe the U.S. can meet that demand here at home. It starts with reforming the system to support the science-forward innovation parents already want.

The upcoming Operation Stork Speed roundtable is a critical opportunity. If we focus on quality and innovation, and strengthen the domestic supply chain, we can deliver on what today’s parents expect and what tomorrow’s babies deserve. The health of future generations depends on it.

Ron Belldegrun is Co-Founder and CEO of ByHeart Infant Nutrition

RealClear Health Article

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