A Letter from Our Founders: Advancing Infant Nutrition Together

To our esteemed Scientific Advisory Board, Medical Advisory Board, and our Pediatric Nutrition Coalition,

We are in a historic moment with the potential to dramatically accelerate innovation in infant formula. This month marked a major milestone as the federal government convened a panel of experts in Washington, D.C., to begin its first review of infant formula nutrition standards in nearly 30 years. The review is part of Operation Stork Speed, a Department of Health and Human Services initiative designed to strengthen domestic supply and advance innovation across the category.

Rather than dwell on the delay, we at ByHeart are energized by what this moment means for the future of infant nutrition. In our recent op-ed in RealClearHealth, we share our perspective on what the industry needs to focus on in order to drive meaningful and lasting change in this critical category.

For those familiar with us—Ron and Mia, siblings and co-founders, and the team at ByHeart—you know this company was founded with fresh eyes, real optimism, and a belief in what the future could be. Not as a critique of the past, but as a step toward a better future. We saw a category where three companies had dominated 90% of the formula shelf for nearly a century, and innovation had stalled. But we knew there was a better way. For us, it was never just about getting to market quickly—it was about doing it right. Many of you have been on this journey with us for nearly a decade. We’ve seen firsthand the work you’ve pioneered to characterize breast milk and understand the bioactive components that drive its benefits; the work of our ingredient partners to source naturally derived ingredients found in breast milk; the endless hours you’ve spent with patients, guiding them through one of the most critical decisions they’ll make—what to feed their babies; and the growing groundswell of parents rightfully demanding more. Because when it comes to a baby’s sole source of nutrition, they deserve the very best.

With progress comes responsibility. You’ve moved the science forward, and we’ve always believed it’s our role—as manufacturers and as an industry—to push past the regulatory and operational barriers that have slowed innovation. Infant formula is one of the most highly regulated foods in the world, which makes the work harder, but never optional. Breakthroughs in breast milk science belong in action, not on the sidelines.

Together, we identified what was possible and then built toward it.

• Rather than following the traditional path of white-labeling an old recipe, we designed our own from scratch. But the only way to do it right was to do it ourselves. So we built three manufacturing facilities here in the U.S.—and then ran one of the largest clinical trials from a new brand in over 25 years, published in JPGN.
• We view breast milk as our north star and designed a patented protein blend to get closest to it. Rather than use skim milk and whey protein concentrate, like most formulas on the shelf, we intentionally added the two most abundant proteins in breast milk—alpha-lactalbumin and lactoferrin—combined with hydrolyzed protein, to infant formula for the first time in the U.S.
• Instead of using skim milk, we led the work to register organic, grass-fed whole milk as safe for use in infant formula so we could rely on its natural fat to meet infants’ fatty acid needs. That shift allowed us to reduce seed oils and remove conventional oils like palm and soy.
• We believe contaminant testing should be rigorous. That’s why we invited independent, third-party testing for more than 400 contaminants. The effort earned us the Clean Label Project’s Purity Award, the First 1,000 Days Award based on European standards, and Pesticide-Free Certification—and we’ve since watched others follow in our footsteps.

Today, we see even more hope. The last 10 years have been remarkable in advancing breast milk science, and the next 10 will move even faster. For the industry to keep pace with this next era of momentum in breast milk science, translate bioactive functional ingredients to babies, and support a fundamental shift toward food as health, we need to seize this historic moment to drive alignment across policy, science, and industry.

Here is where we are focused:

• The nutritional review must go beyond subtraction. It’s not just about removing what doesn’t belong, but about purposefully adding the critical bioactive components in breast milk that deliver real functional benefits. The next generation of formula isn’t just an updated version of an old recipe—it’s complete reinvention: clean and highly functional.
• We should raise the bar to require robust clinical evidence behind every claim. All FDA-approved formulas are safe. But if we aim to usher in a new era of food as health, parents must be able to distinguish between dated ingredient claims and those backed by rigorous, randomized clinical trials on a finished formula.
• We must incentivize innovation, not shortcuts, by supporting companies that invest in original science and build their own supply chains. As the first new manufacturer in over 15 years and the first to conduct a published clinical trial, we hope it won’t take another 15 years for the next. This isn’t about competition. It’s about advancing clinical research, encouraging transparency, and enabling the kind of scientific discovery and food-tech innovation that will shape the next generation.

The federal government has put out a request for information (RFI) on nutritional guidelines on infant formula. Our Chief Medical Officer and Chief Scientific Officer, Dr. Devon Kuehn, has been on the forefront of this work for years and is leading our detailed perspectives. We invite you to join us in helping to shape the future direction of infant formula standards, please click HERE. We also always want to grow our group of passionate experts, so do share ByHeart’s mission with anyone you think might offer valuable perspective and might be interested in joining our efforts.

We’re deeply grateful for the years many of you have spent working alongside us to advance infant nutrition. At the same time, we remain humble—if it took evolution two hundred thousand years to perfect the original superfood, breast milk, we won’t get there in ten. That’s why we’re energized to keep pushing forward, together. There has never been a more important moment to do this work.

Fondly, 

Ron & Mia, Co-Founders of ByHeart