Infant formula manufacturers replicating the biological benefits of human milk are hitting regulatory roadblocks in a landscape where safety and transparency are paramount.
As the industry works to make infant formula more biologically similar to human milk, it is confronting three distinct challenges – closing long-standing nutritional gaps, addressing increased safety concerns following recent contamination incidents, and navigating existing regulatory frameworks not designed for complex ingredients.
Those challenges are converging at a moment when new bioactive ingredients promise to transform what formula can do for infant health, while raising new questions about how these ingredients should be evaluated and overseen.
Beyond nutrition
What distinguishes this latest wave of infant formula innovation is its focus on function. While traditional formula has been evaluated based on infants’ growth and development, new bioactive ingredients boost immunity, metabolism and long-term health.
Infant formula contains lactoferrin from bovine proteins, but “they’re not the same from a chemical composition perspective” compared to human lactoferrin, explained Laura Katz, CEO and founder of Helaina, which produces bio-identical human lactoferrin called effera. “They’re not the same from a functionality perspective.”
To close the nutrition gap between bovine and human lactoferrin, companies like Helaina are using precision fermentation to produce proteins that are structurally identical in amino acid sequence to those found in human milk.
Although such ingredients could move formula closer to breast milk’s biological complexity and functionality, they also raise the bar for how products are tested and evaluated.
Increased contamination raises concerns over regulatory oversight
The last several years have seen increased contamination occurrences from large CPGs like Nestlé and Danone to smaller brands like ByHeart.
Although FDA’s testing across 300 infant formula brands identified trace contaminants, it did not specify how these findings relate to standards, enforcement or pre-market testing. FDA’s September 2025 launch of its infant formula program Operation Stork Speed aims to accelerate recall communications and processes, although critics raise concerns about the agency’s limited bandwidth and a need for stronger regulatory oversight.
A more complex system
As formula becomes more biologically sophisticated, safety and regulatory its systems face new pressures.
The infant formula industry has not yet fully adapted to the implications of introducing novel bioactive ingredients – particularly for vulnerable populations like pre-term infants, according to Elena Medo, a longtime human milk expert and CEO of Elodie Health.
“We are talking about the smallest and the most fragile patient in the hospital,” she said, emphasizing stricter oversight on ingredient testing and safety across formulas. “Their metabolism is just completely immature.”
Medo says she worries oversight of new ingredients is insufficient and should be held to a higher bar akin to pharmaceutical testing.
However, Katz argues that the pathway for new ingredients, particularly in infant formula, already includes significant scientific validation when done properly.
“It is millions of dollars of work to generate all the data,” she said, citing regulatory requirements around safety and digestion profiles, in addition to publishing findings in peer-reviewed journals for public access.
A new phase of innovation
Infant formula is a precise blend of nutrients like fats, carbohydrates and proteins. But the gap between breast milk and formula remains stark where water content is their only real similarity, according to Medo.
The challenge for companies is to recreate the bioactive components in breast milk that support immunity, digestion and long-term health. The most highly concentrated bioactive protein in breast milk is lactoferrin, which is missing from formula, explained Katz.
“These are also complex bioactive molecules,” Katz said. “Omega-3s are bioactive, HMOs are bioactive. Making the proteins through fermentation makes sense as the next wave” of innovation in formula.
The goal is not just to add more ingredients to infant formula, but to precisely determine the biological functions of breast milk, Katz explains. Proteins like lactoferrin are abundant in breast milk, supporting immunity and iron absorption.
Improving the bioactive content and quality in formula “doesn’t happen all at once,” Katz said. Rather, “innovation happens [an] ingredient at a time.”
That incremental approach – particularly with human lactoferrin which was produced using genetic engineering and recombinant expression systems in the late 1980s – reflects both the technical complexity of replicating human milk and the regulatory constraints governing infant nutrition.
But the slow progress in infant formula also underscores how much of the original system remains intact.
“Infant formula has not really changed that much in the last 40 years,” Medo emphasized.
Previous generations focused on replicating macronutrients, however, recent efforts introduced compounds like omega-3 fatty acids and human milk oligosaccharides (HMOs), which are complex sugars linked to gut health and immunity.
Redefining what ‘better’ means
As ingredient innovations advance, what should infant formula aim to achieve?
For decades, the benchmark has been infant’s basic growth and tolerance. But as science and technology evolves, the definition of what constitutes a “successful” formula might shift, too.
“I’d like to see more thought about the design of the products,” Medo said. “There’s been this race in infant nutrition to have this ingredient or that ingredient that makes it closer to human milk,” Medo said.
She continued: “So, if they can ... do their work to actually have a surrogate set of nutrients that are more human milk-like, I think that would be really exciting.”
At the same time, the industry still lacks a unified framework for measuring outcomes beyond infant growth – such as immune function or long-term disease risk, according to Medo.
Katz agrees that the goal should ultimately be to replicate the functional benefits of human milk, but emphasizes that doing so will take time and sustained collaboration.
“It’s our obligation as an industry to bring the [nutrients] in breast milk” through infant formula, she emphasized.
‘Babies need the best, most innovative products’
For the infant formula industry, the emerging technology around bioactive ingredients presents both an opportunity and challenge.
On one hand, biotechnology makes it possible to recreate components of human milk that were once out of reach. On the other, those production methods introduce new layers of complexity into a system already under scrutiny.
“Babies need the best, most innovative products,” Katz said. “They need the safest products, and that has to happen in concert.”
For Medo, the stakes are equally clear, but the emphasis remains on restraint and rigor.
“It’s a tremendous responsibility to make food for these little babies,” she said.
As the industry pushes beyond nutrition and into biology, the central question is no longer just how to feed infants, but how closely science can, and should, attempt to replicate nature.
