ByHeart infant formula manufacturer celebrates FDA registration

BYHEART 0428ByHeart co-founder and CEO Ron Belldegrun, left, and co-founder and president Mia Funt, right, cut a ribbon April 28 at the company’s  Exeter Township infant formula manufacturing plant. (WES CIPOLLA – MEDIANEWS GROUP PHOTO)

EXETER TOWNSHIP — It’s not easy to start a business in the $70 billion baby formula industry. It is the most regulated foodstuff in the world. Three companies — Similac, Mead Johnson and Nestlé — have a stranglehold on 90% of the U.S. market. Recent shortages due to an ongoing supply chain crisis have caused panic.

Still, Ron Belldegrun and Mia Funt found a way.

In 2016, they founded ByHeart, one of only five formula makers in the United States and only the fourth to be vertically integrated.

“The barriers to innovating are very high,” Funt said. “It took us five years to get here. Indeed a labor of love, because we set out to innovate a product and disrupt a category that hadn’t been changed in decades.”

“It’s obviously a heartbreaking time for parents not to be able to find infant formula,” Belldegrun said. “There is a scarcity of manufacturers in this country, working very hard to supply parents, but in such a critical area we need more options.”

BYHEART 028ByHeart co-founder and CEO Ron Belldegrun addresses guests and state officials during a ceremony at the infant formula manufacturer’s Exeter Township facility, April 28. (WES CIPOLLA – MEDIANEWS GROUP PHOTO)

Every aspect of ByHeart’s production, from research to manufacturing, takes place under one roof — the company’s $21.6 million FDA-registered facility on 61 Vanguard Road in Exeter Township.

On a blustery Thursday afternoon April 28, ByHeart held a ribbon cutting ceremony at the site, which featured an unexpected appearance by Gov. Tom Wolf.

“This is a really big deal for all of us, and it’s a big deal for Pennsylvania,” Wolf said. “ByHeart shows that we are an innovative state.”

Wolf said that ByHeart is the future not only of infant formula, but of agriculture, Pennsylvania’s largest industry.

“Innovation, revolution, change,” he said. “That’s what you’re doing.”

Wolf was joined by State Agriculture Secretary Russell Redding and state Sen. Judy Schwank (D-11th Dist.), who spoke about ByHeart’s importance to the economy and environment of Berks County and Pennsylvania.

“We are keenly aware that food and agriculture is life-sustaining,” Redding said, “in every step of the supply chain.”

ByHeart formula is made with organic grass-fed milk. Its clinical trial, which involved 300 infants, was the largest in 25 years for a brand of formula.

“There are farmers here who are going to take advantage of this opportunity,” Schwank said, “and they are going to give you a great product. Very wholesome product.”

In his remarks, Belldegrun said that until now, recent breakthroughs in infant nutrition have been out of reach for the general public. He thanked the scientists, ingredient providers, corporate and manufacturing teams who supported him.

“This is an unprecedented time in our industry,” he said. “A pandemic, and a major national recall, leading to shortages across the United States. This is far too fundamental a food for such a fractured supply chain.”

Belldegrun said that building in Berks County was “a no-brainer.”

“This is a state for dairy innovation,” he said. “Baby formula is the highest-value dairy in the world.”

He and Funt spent two years searching across the world for “the highest-quality manufacturing.” They chose Pennsylvania because of its heritage of dairy farming, support from federal and state officials, including millions of dollars in grants, and what Belldegrun called “a wonderful workforce that was committed to transforming the category for us.”

“It was very clear to us that to be able to really transform baby nutrition,” he said, “we needed to build our own manufacturing.”

Funt credits ByHeart’s success to them creating the company — and their formula recipe — “from scratch.” She said that her daughter is “fully on ByHeart and loving it!”

“We wanted to do the hard work,” she said, “because we knew that that’s what it took to truly innovate. We didn’t want to take shortcuts, because that wouldn’t mean creating the most nutritious and wholesome alternative to breast milk.”

ByHeart’s new facility is expected to create 50 jobs over the next few years, and the company’s investments into Berks County are not over. Belldegrun and Funt will invest an additional $26 million into the Berks county manufacturing facility.

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