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New central Pa. baby formula manufacturer says we are throwing everything we have at this

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In the middle of the baby formula shortage, a new factory in Berks County might be able to help fill the void.

After six years of planning along with conducting research and clinical trials, ByHeart launched its infant formula on March 23 from its plant in Exeter Township, Berks County, near Reading.

With the nationwide shortage, the timing couldn’t have been better for ByHeart’s launch.

“I was at a grand opening,” Gov. Tom Wolf said last week on Pittsburgh-based KDKA’s morning radio show. “The commonwealth actually helped to build I think the first baby formula factory … in the world over the last something like 15-20 years in Pennsylvania – Berks County.”

It might have taken years to prepare to launch its products, but you could say that ByHeart was thrown right into the deep end of a national crisis immediately following its launch.

Ron Belldegurn, CEO and co-founder of ByHeart, said his company is taking immediate actions to help with the baby formula shortage.

“As the first new infant formula manufacturer to be registered with the FDA in over 15 years, we’re working toward investments that could feed another 500,000 babies annually, which represents roughly 13% of new births a year,” he said. “In the near-term, we feel an immense responsibility to be part of a sustainable solution to this national crisis.”

Belldegurn said those actions include moving from a 24-hour facility five days a week to manufacturing baby formula around the clock seven days a week; “hiring relentlessly”; investing more than $30 million in manufacturing capabilities to continue to scale volume of formula; and adding customer service employees and working with industry, state and federal officials, and regulatory bodies to seek immediate relief and increased production of formula.

“We are throwing everything we have at this and taking clear and immediate actions,” he said.

Belldegurn said it took a long time to launch ByHeart’s baby formula because the founders wanted to bring something better to the industry.

“We are the only new infant formula brand to build from the ground up: to rewrite the recipe from scratch, to own our own manufacturing, to directly oversee every supplier relationship and every ingredient,” he said. “We built the hard way, because we feel tremendous responsibility to ensure that this industry changes. The parents in this country need more than three big infant formula companies controlling approximately 90% of the market. Never again should we have to wonder how to find food for our babies.”

For millions of babies in the U.S., formula is the only source of nutrition recommended for infants who aren’t exclusively breastfed.

Infant formula shortages have been going on for months and stem from a combination of factors, including a recall, inflation and supply chain problems related to the COVID-19 pandemic.

The situation was exacerbated in February when Abbott Nutrition recalled several major brands of powdered formula and shut down its Sturgis, Michigan, factory when federal officials began investigating four babies who suffered bacterial infections after consuming formula from the facility. Abbott recalled Similac, Alimentum and EleCare powdered infant formulas.

When asked if ByHeart was taking any special precautions in light of the possible contamination at the Abbot plant, Belldegurn said that ByHeart incorporated modern innovations in breast milk research and nutrition science to bring babies the “most highly functional ingredients” but also the cleanest ones available.

“Our dedicated blendmasters oversee rigorous quality controls – think custom mixers, equipment customized to this first infant formula, temperature checks, and hundreds of trials to date to ensure every condition is optimal,” he said. “Additionally, because of our farm to formula oversight and unique manufacturing ownership – we have hand-selected the highest quality ingredients, directly from partners we consider family.”

Belldegurn said the company’s diligence doesn’t stop at ingredient, packaging, laboratory, warehouse, and packer approval. “We audit our vendors and partners to qualify every year anew, in a process that takes approximately 1,000 hours and involves nearly 110 steps,” he said. “Our vitamins and minerals come from some of the safest environments around the world to try to keep heavy metals out – before they even get to our facility.”

Last year, ByHeart, a New York company, was awarded a $1.75 million Redevelopment Assistance Capital Program grant from the state of Pennsylvania to help fund the new operation in Berks County, which is about an hour and 10 minutes from Harrisburg.

“Everybody’s working on this and, uniquely, I think Pennsylvania has actually done something on that,” Wolf said. “So I’m proud of Pennsylvania’s role in this.”

The company has said it invested $21.6 million in the facility and plans to invest 26 million more.

“Pennsylvania, I think, is the only state that is actually doing a part in the world to actually fill this void,” Wolf said.

Last week, the FDA and Abbott agreed on the next steps to reopen Abbott’s facility in Sturgis and it also announced guidance that will allow major formula manufacturers to safely import formula that is not currently being produced for the U.S. market. The Washington Post reported that the CEO of Abbott, Robert Ford, said the plant should reopen in early June “and that it would take six to eight weeks after reopening before the product is available in stores.”

U.S. Senator Bob Casey, along with four other senators, have introduced the Protect Infants from Formula Shortages Act that they say will protect families and patients who rely on infant formula and other essential sources of nutrition.

The bill would require manufacturers to notify the Food and Drug Administration of potential supply disruptions and give the FDA additional tools to proactively work with manufacturers to help prevent or mitigate potential shortages.

President Joe Biden has invoked the Defense Production Act to address the country’s infant formula shortage caused by Abbott Nutrition’s voluntary recall.

Biden is requiring suppliers to direct needed resources to infant formula manufacturers before any other customer. He has also directed the Department of Health and Human Services and U.S. Department of Agriculture to use Department of Defense commercial aircraft to pick up overseas infant formula that meets U.S. health and safety standards. The White House says this will speed up the process.

On Sunday, Biden announced that infant formula is being delivered to the state.

“We have secured a second flight to transport Nestlé specialty infant formula to Pennsylvania,” he said. “The flight and trucking will take place in the coming days, and I will continue to keep you updated.”

The shortage is impacting grocery stores in south-central Pennsylvania. Several grocery store chains, including The Giant Company, Karns Foods and Weis Markets, report spotty inventory and challenges stocking enough formula. A recent visit to several grocery stores in the Harrisburg area show nearly depleted shelves of baby formula.

Several national retailers, including CVS, Target and Walgreens, have imposed purchase limits. Giant and Wegmans also have purchase limits, according to signs at south-central Pennsylvania stores.

“Though product is available, the situation is fluid and it is possible that a particular item may be unavailable,” Ashley Flower, a spokesperson for Giant told PennLive previously.

Staff writer Jan Murphy, and the Associated Press contributed to this report.

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