Reading, Pennsylvania - In a converted manufacturing plant in Reading, Pennsylvania, two University of Pennsylvania graduates and siblings opened America’s newest baby formula factory.

The timing for ByHeart – which was launched in March – was near perfect: A severe baby formula shortage has gripped the nation due to recalls and a recently reopened Michigan formula plant shutdown earlier this year.

"We are disrupting a category that has not been disrupted in decades," Mia Funt (39), cofounder and president, said in an interview with The Philadelphia Inquirer. Her brother and cofounder Ron Belldegrun (36) is chief executive officer.

Four companies control 90% of the US market for infant formula: Abbott, Gerber, Mead Johnson, and Perrigo Nutritionals. Perrigo produces store-brand infant formulas for major stores including Walmart, Target, Kroger, CVS, Walgreens, and Sam’s Club.

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ByHeart sold its FDA-approved formula to customers in all 50 states within a week of launch, and they are planning on expanding the plant, Fund and Belldegrun said.

It’s a rare new entrant in a highly regulated infant food business that’s controlled by a few big companies.

ByHeart’s founders say they are only the fourth vertically integrated infant formula brand in the United States with end-to-end oversight of production, a stable supply chain, and research and development.

ByHeart processes raw, whole milk from Pennsylvania dairy farms; turns it into powder formula using a patented blend of the two proteins in breast milk, alpha-lactalbumin and lactoferrin, as well as broken down proteins; and gets the closest to breast milk in the market, the founders said.

"In addition to supporting good health from birth, this investment in ByHeart will create good jobs, economic impact, and support for agriculture in the commonwealth and, indeed, the entire country currently suffering from shortages in this supply – it’s an all-around win," Gov. Tom Wolf said in April, when the plant held a ribbon-cutting ceremony.

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"This cutting-edge ByHeart facility is exactly the type of project I’ve wanted to see happen here in Berks County," said State Sen. Judy Schwank. "This new facility will make an immediate impact on our local economy and provide a boost to Pennsylvania’s dairy industry."

ByHeart hopes to relieve an acute shortage of infant formula nationwide: According to data analyzed by Axios, 29% of baby formula inventory was out of stock nationally the week of March 13, up from 18% the start of 2022.

America’s shortage is so acute that importers as far away as Australia were quickly approved to send tins of powder here for sale. On Tuesday, a UPS jet with a planeload of Australian formula – the equivalent of two million baby bottles – landed at Philadelphia International Airport to be distributed regionally and nationally.

Federal agencies such as the FDA are taking steps to improve the supply of infant and specialty formula products in the US, but shelves remain partly or largely bare in many stores.

The shortage continues, even as Gerber increased the amount of its infant formula available to consumers by about 50% in March and April. Mead Johnson is supplying 30% more product as of May, the FDA said.

ByHeart’s infant formula is available only online at byheart.com, priced at $39 for a 680 gram can.