Breast milk
Reuters

1 in 5 infants is allergic to baby formula made with cow's milk, something that can create significant feeding challenges for parents. Del Alfonso's daughter is among them.

After more than a decade supporting infants with specialized nutritional needs, Alfonso told Latin Times that he experienced an inflection point came when his second daughter was born with a cow's milk allergy, solidifying his belief that the industry "needed to change".

At the moment, breastfeeding was not an option for Alfonso's daughter, leaving the family to rely on hypoallergenic formulas that, however, were so unpalatable the baby refused them.

As a pharmacist with a master's in food science, Alfonso was also acutely aware that feeding his daughter these formulas meant his newborn was consuming around 85 grams of industrial sugar per day. "The equivalent to two cans of soda", he noted.

Despite being a 150-year-old-industry, infant nutrition has seen very little innovation – especially in Latin America. As a result, many parents facing allergy-related feeding challenges have limited options, even as evidence shows that these issues are becoming more common.

Driven by both his industry experience – previously leading one of Brazil's fastest-growing nutrition startups – and his daughter's allergy battles, Alfonso founded Harmony Baby Nutrition, a Boston-based startup using molecular nutrition to develop hypoallergenic baby formulas inspired by human breast milk.

Harmony's formulas have reduced added sugars, removed dependence on dairy, and also seek to deliver a more palatable taste closer to breastmilk.

Harmony's first product is Melodi, set to launch in the U.S. market in early 2026. It is a hypoallergenic formula for toddlers with cow's milk allergies that has demonstrated a 61% higher sensory acceptance compared to standard hypoallergenic formulas.

The startup also has plans for Latin American expansion. In early October, Harmony announced that it had secured USD$5.9 million (R$30 million) from FINEP-BNDES, one of Brazil's most competitive innovation funding programs.

It marks one of Brazil's biggest national investments in infant nutrition and will fund the creation of a world class Research & Development (R&D) center in Belo Horizonte.

Alfonso emphasized that hypoallergenic formulas are only the beginning; over the next decade Harmony plans to introduce products that "serve both allergic and healthy babies".

Now in its funding stage, Harmony is gaining attention in the $101 billion formula industry – an industry built on milk from a different mammal entirely, dominated by a handful of major players, and marked by contamination scandals.

Harmony's first product: Melodi

Unlike the majority of "allergy-friendly" formulas that rely on industrial sugars like corn syrup solids or maltodextrin, Melodi is made with lactose – the natural carbohydrate found in human milk.

It includes Human Milk Oligosaccharides (HMOs) which support gut health and immunity whilst producing a gentler, more familiar taste for infants.

Melodi is almost 50% compositionally similar to human breastmilk. The figure compares to the current formula options, which have less than 3%. Additionally, Alfonso said it is expected to be priced at a similar margin to the current hypoallergenic leading brands.

Through their use of advanced technology, they also eliminate reliance on dairy which is responsible for 80% of the formula industry's carbon footprint, improving emissions alongside quality and taste.

Harmony's Research and Development Center

The FINEP-BNDES joint initiative is a flagship innovation program under Brazil's Nova Indústria policy, backed by R$3 billion to boost national innovation capacity. It selectively funds companies poised to build large-scale R&D infrastructure and advance the country's industrial and technological goals.

This investment will not directly fund commercial operations but will instead support the creation of a new R&D and Innovation Center, set to begin implementation in early 2026.

The center will function as Harmony's global hub for advanced infant-nutrition research, bringing together expertise in food science, biotechnology, and clinical nutrition to develop cleaner formulas aligned with breastmilk, including next-generation hypoallergenic alternatives.

The initiative includes hiring 25 professionals, including at least five scientists specializing in infant nutrition research.

Harmony currently outsources its products in Europe. However, the approval of the grant marks a significant change. Alfonso expressed the Harmony team's excitement, saying, "in two to three years, we can have our own manufacturers producing our products, financed by government funding."

Is cow's milk-based formula inherently flawed?

Today, around 95% of baby formula is cow's milk-based, meaning that for many infants, their sole source of nutrition comes from the milk of another species. Alfonso clarified that this leads to complications because "cow's milk is designed for a completely different digestive system" – cows have four stomachs, while humans have one.

Cow's milk contains proteins that are absent from human milk, these trigger 20% of adverse reactions found in infants and need to be "broken down into such small pieces that it smells and tastes very bad," explained Alfonso.

This process of turning cow's milk into powder is incredibly complicated and creates much opportunity for contamination.

Over the past five years alone, the U.S. has experienced different infant formula contamination incidents and nationwide shortages.

In November, the U.S. Food and Drug Administration issued a recall of all ByHeart products from all major retailers after evidence of botulism contamination – a life-threatening virus which attacks the nervous system – from their powdered infant formula.

As of early December, 51 infants had been hospitalized with suspected or confirmed infant botulism after consuming contaminated ByHeart Infant Formula, resulting in the company largely halting its operations.

Alfonso believes that Harmony's products have the potential to meaningfully address this dilemma: "This is why we do the kind of innovation we do; we can produce products that are liquid and sterile", Alfonso assured that, "Harmony's products are pre-packaged, liquid, and ready-to-go".

"Infant nutrition is such a big industry and so ready for disruption, but it is not an easy industry," said Alfonso.

He explained that the industry's complexity is driven by both "aggressive players" and the nature of the product itself: "Formulas are something between drugs and food...they are the most complex food in the world; a single formula can contain more than 30 ingredients."

Part of the future product pipeline is an infant formula that will feature a complete profile of human milk proteins, therefore fully replacing cow's milk-derived components. This product is expected to launch within the next five to seven years following clinical trials and will hold a further improved, natural flavor profile.

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