Newly FDA-registered baby formula maker offers solution to ‘unfathomable’ shortage

ByHeart baby formula demand surges following FDA approval of its ‘entire’ self-owned supply chain

One U.S.-based baby formula maker is celebrating a story of opportunity meeting preparation, offering a solution to what its CEO considers a national crisis.

"It's unfathomable," ByHeart’s Ron Belldegrun told FOX Business’ Lydia Hu on Tuesday. "This is the sole source of nutrition for babies."

ByHeart, which makes its formula in Reading, Pennsylvania, has become the first new infant formula manufacturer to earn FDA registration in America in more than 15 years.

Now, as only the fourth fully-integrated, American-made formula brand in the country, ByHeart also announced an additional $26 million investment into their Pennsylvania facility, according to a press release.

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Although demand for the company’s formula has surged amid a nationwide formula shortage, Belldegrun explained they prepared for the fragility of the baby formula supply chain by producing strictly within the U.S.

ByHeart baby formula building

ByHeart CEO Ron Belldegrun says the company didn't realize how important a vertically-integrated supply chain would be during the baby formula company's inception five years ago on "Varney & Co." Tuesday, May 17, 2022. (Getty Images)

"What we didn't realize is five years later, how important that decision to really vertically integrate and own our entire supply chain would be in enabling us to be part of a solution now to this national crisis," Belldegrun said.

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Meanwhile, The U.S. Food and Drug Administration announced it will take "important steps" to remedy the country's formula supply chain after American parents and pediatricians made their concerns known about the current formula shortage.

"We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so," FDA Commissioner Robert M. Califf said last Tuesday. "We are doing everything in our power to ensure there is adequate product available where and when they need it."

Although ByHeart just recently launched in March, its CEO noted that it took on three months-worth of customers just last week, with plans to ramp up supply.

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FOX Business’ Cortney Moore contributed to this report.