ByHeart aims to shake up US infant formula industry with small-batch offerings

03 Jun 2021 --- ByHeart is aiming to become the fourth fully integrated, US Food and Drug Administration (FDA)-registered, US-based infant formula brand in the country. According to the company, there is currently a limited supply chain in the infant formula space as only four companies in the US produce infant formula – three of which own approximately 90 percent of the market.

Following the largest clinical trial for a new infant formula brand in the last 25 years, ByHeart is set to launch its small-batch recipe infant formula this fall.

“We are expected to be the first US formula made with grass-fed, organic whole milk from farms that strive for regenerative practices. We are changing the standard of what an infant formula recipe should be,” says co-founder Ron Belldegrun.

New companies wanting to enter the infant nutrition sector have had to go through a single contract manufacturer who manages the process from start to finish.

ByHeart has forgone this traditional route by acquiring and upgrading a US manufacturing facility in Pennsylvania. It says it is the first new infant formula company in decades to do this.ByHeart was founded by siblings Ron Belldegrun and Mia Funt in 2016. 

Enabling greater control
The facility accommodates full in-house R&D capabilities, direct sourcing and ensures complete oversight of rigorous preventative safety measures.

This control of ingredients and process allows the company to evolve its formulas more quickly and effectively to meet babies’ needs.

ByHeart also works directly with its suppliers to consider and hand-select every ingredient. The proprietary small-batch blending process ensures the integrity and functional benefits of the ingredients are maintained at high quality levels.

Establishing clinical backing
ByHeart has now also carried out what it says is the largest infant formula clinical trial for a new brand in the last 25 years while meeting FDA’s rigorous requirements for infant formula. 

It examined how nutrition impacts babies’ holistic health and development, with the results set to be released in the coming months.

The founding of the company was inspired by modern advancements in nutrition science and decades of breast milk research, both of which have outpaced innovation in the infant formula space. Using this research, the team developed a blend of ingredients designed to deliver the holistic health benefits of breast milk.

“We developed a proprietary protein blend because we believe proteins are the key to most closely mirroring breast milk in order to support a strong immune system, a healthy gut microbiome and easy digestion,” says Belldegrun.

He continues that nutrition science has also meaningfully developed to support the importance of good fats in early development.The company has a team of experts at the forefront of immune, microbiome, cognitive and digestive health.

Empowering parents
Additionally, the company will be rolling out programs and initiatives that provide health and wellness education. This aims to empower all parents by giving them access to resources and experts who can support them through every feeding moment.

“Our team is dedicated to transforming a category by building something truly new, and more importantly, something that gives parents confidence in the food they are giving their babies – in every ingredient,” says co-founder Mia Funt.

Also in the organic formula space, FrieslandCampina Ingredients has just launched a premium demineralized whey ingredient. 

Last month, infant nutrition industry experts also shared that the arena is becoming more specialized, with conditions like allergies and anxiety driving diversified options.

Edited by Katherine Durrell