ByHeart, the company linked to a botulism outbreak in infants, shut down one of its manufacturing plants this year after federal investigators found a series of safety violations, including a leaking roof and hundreds of dead bugs where infant formula was produced.
Inspection reports by the Food and Drug Administration detailed significant problems at the company’s site in Reading, Pa. Although the reports did not involve the plants that made the formula recalled in the botulism outbreak, food experts say the findings raise concerns about the company’s safety record.
For example, in July and August 2022, ByHeart found cronobacter sakazakii, a bacterium that can be deadly to infants, in the processing area of the plant. When the company also found the bacteria in a can of finished formula weeks later, it faulted the laboratory that discovered it.
Months later, F.D.A. inspectors returned to the Pennsylvania manufacturing site, detecting mold in a tank meant to contain clean water, finding more than 2,700 dead insects in a food production area and learning the plant had dealt with several roof leaks. The F.D.A. classified the inspection at its highest tier of concern.
Now the F.D.A. is investigating the company’s facilities in Allerton, Iowa, and Portland, Ore., which produced the formula that was widely recalled from supermarket shelves. Inspectors are trying to determine if there is a link between the processing centers and the 15 infants who were treated for botulism toxicity after consuming ByHeart formula, officials said. No deaths have been reported.
“At ByHeart, we are committed to the health and safety of babies — it is our top priority,” Dr. Devon Kuehn, the company’s chief medical officer, said. “At the core of that commitment is adhering to the highest safety standards. We exceed all U.S. regulations.”
Experts said that this outbreak, and another involving deadly listeria linked to prepared pasta, suggested that top government health officials should do more to ensure food safety. The government shutdown and a year of layoffs have left federal agencies demoralized and stretched thin.
At least two families filed lawsuits against ByHeart over their children’s illnesses in recent days. They include Stephen and Yurany Dexter, who live in Northern Arizona. Their case states that their daughter, who was born in July, started using the formula and grew increasingly weak until the family could not wake her.
They rushed to an emergency room in Flagstaff, and the baby was flown by air ambulance to Phoenix Children’s Hospital.
She was initially diagnosed with muscular dystrophy with botulism as a possibility. The infant gradually recovered and was sent home from the hospital with a feeding tube; she is regaining strength. The family does not know if there will be long-term effects, the lawsuit said.
Hanna and Michael Everett, who live in Kentucky, also sued ByHeart over their 4-month-old daughter’s illness. When she became too weak to take a bottle, her parents took her to the emergency department. She was diagnosed with botulism on Nov. 9, and the treatment was shipped to her from California.
Both cases were filed in federal court and claim that ByHeart was negligent and that their formula was dangerous.
ByHeart said that Friday evening it began extensively testing all its batches, and that it has given F.D.A. officials unrestricted access to its plants. The agency took sealed cans of formula from the Portland facility for testing.
The Clostridium botulinum bacteria that cause paralysis in infants was found in an opened can of ByHeart formula. ByHeart said that none of the bacteria had been found in an unopened can.
“The F.D.A.’s investigation into infant botulism in the U.S. is still ongoing, and we feel that there are still too many unanswered questions,” the company said in a statement.
Federal health officials have told the public to throw away all ByHeart formula.
Cases emerge in 12 states
ByHeart has capitalized on the Trump administration’s agenda to Make America Healthy Again by promoting curated organic ingredients. Robert F. Kennedy Jr., the nation’s health secretary, has championed Operation Stork Speed, an effort aimed at improving outdated recipes for infant formula.
“It is great that they’re focused on chronic disease that is diet-related,” said Sandra Eskin, chief executive of the advocacy group Stop Foodborne Illness.
“They do not at all in any of their drafts or reports or outlines talk about foodborne illness,” she said. “Foodborne illness, yes, it’s an acute condition, but for many, many people, they have lifelong health consequences.”
Infant botulism results from the ingestion of spores produced by clostridium botulinum bacteria, which can colonize the intestines, multiply and produce toxins that gradually paralyze a baby, according to Kristin Schill, a food safety expert who studies botulism at the University of Wisconsin. Symptoms include general weakness, a quiet cry and diminished feeding.
Public health officials in California are often the first to know about cases of infant botulism. State scientists developed and sought F.D.A. approval for the only botulism antitoxin available for infants, and offer 24-hour support to doctors.
There are typically about 130 to 180 cases of infant botulism reported in the United States each year, according to the Centers for Disease Control and Prevention. Dr. Erica Pan, California’s top public health officer, said the department noticed an uptick of reports beginning on Aug. 1. Of about 84 infants treated for botulism, she said, about 36 were fed formula, including 15 who ingested ByHeart formula. Those infants were from 12 states, including Texas, Illinois and California.
Dr. Pan said that the number of infected infants who had consumed ByHeart formula jumped out at her, because the company’s sales account only for about 1 percent of the national formula market.
“So that was a very disproportionate, very concerning signal of what’s going on here,” said Dr. Pan, who is also a director of California’s health department.
She said that laboratory staff members in the state cultured one sample of the botulinum bacteria found in an opened can of ByHeart. In a standardized test, they injected the toxin in mice, which got sick very quickly.
ByHeart stepped in during formula shortage
Ron Belldegrun, ByHeart’s chief executive, founded the company with Mia Funt, his sister, after a career in venture capital and hedge fund management. Ms. Funt, the company’s president, helped form ByHeart after working as a marketing and business development executive.
They have said they settled on a recipe that included whole milk, instead of the standard skim milk, to incorporate the latest research and mimic breast milk.
Mr. Belldegrun said in a recent LinkedIn post that “building three infant formula manufacturing facilities” in the United States was a decision made to “raise the bar.”
“When it comes to control, we’re obsessive in every sense of the word — because this is the most important food for the most important people,” he said.
The company started selling its formula directly to consumers in the spring of 2022. At the time, parents were driving for miles to find scarce quantities of formula after Abbott Nutrition shut down a major plant in Michigan. A shortage of formula was exacerbated by the F.D.A.’s growing concerns about deadly cases of cronobacter poisoning in formula-fed infants and about unsanitary conditions at the Michigan plant.
As Abbott lost market share after the facility’s shutdown, ByHeart and other infant formula upstarts flooded in, hoping to gain traction among new parents.
ByHeart has grown rapidly, raising more than $70 million this spring from investors in a deal that valued the company at more than $900 million. The company sells formula on Amazon and at Target, Kroger, Albertsons and other major retailers.
Since the shortages, the F.D.A. has heightened scrutiny of baby formula makers, including at ByHeart’s plant in Pennsylvania. In August 2023, the agency sent the company an official warning letter claiming that ByHeart had shipped potentially contaminated infant formula to customers without notifying the agency.
The letter raised concerns about operations that began soon after the facility received F.D.A. approval to operate in April 2022. The company said it had spent $21.6 million to convert the plant to make infant formula instead of toddler food.
The agency’s warning letter outlined events from July through August 2022, when the company’s contract laboratory discovered cronobacter sakazakii, in its processing area. These were the same bacteria that set off alarms at the Abbott plant.
By mid-October, ByHeart learned that the same bacteria had been found in its finished product, according to the agency. The bacteria are common in dirt and in kitchen sinks, but infant formula manufacturers are held to high standards to keep their products clean.
The F.D.A. does not impose granular rules for every step food processors must take, given the vast array of foods and the singular safety hazards that may occur with each of them. That means baby formula makers tend to monitor for several types of bacteria, though the type that causes botulism has not been viewed as a risk because illness from it is rare.
The F.D.A. expects companies that find bacteria at a formula plant to conduct a painstaking internal investigation so that the hazard can be eliminated. The agency said that ByHeart failed to do so after cronobacter emerged at its Pennsylvania plant.
ByHeart had concluded that the bacteria in the finished product were the result of contamination from its third-party testing lab, which the lab denied, according to agency reports that did not name the lab. The F.D.A. said the company had also failed to compare the genomic sequence of the cronobacter found at its processing center with that found in the canned formula.
What’s more, the agency said the company erred by withdrawing only two lots of formula from sale after discovering cronobacter. Because ByHeart had not dealt with the source of the bacteria, the company should have destroyed everything in the entire production cycle, the agency said. The company later recalled five lots of formula in December 2022.
“It is important to note that this recall is not related to ByHeart’s own manufacturing in any way,” the company said in a statement at the time.
The company also said it would perform whole genome sequencing on the bacteria it found; the sequencing helps to trace and match the sources of contamination, according to the warning letter. The F.D.A. sent similar letters to two other formula makers around the same time about shipping formula that may have come into contact with cronobacter.
F.D.A. inspectors returned to the Pennsylvania plant in December 2023 and found more problems, according to an agency inspection report provided by Redica Systems, a company that collects and sells the reports.
The Pennsylvania facility had a leaking roof, which was described to F.D.A. inspectors as a roof built in five sections. The age of the roofing could not be determined by facility managers or the roofing company, the inspection report said.
At that plant, the agency also found that ByHeart failed to protect its formula against contamination from pests, with an inspector noting on Dec. 11, 2023, that flies were buzzing overhead in a sensitive area of formula production. In the same area, the inspector observed more than 2,500 dead flying bugs near three insect light traps.
The plant also violated its rules for maintaining temperatures needed to eliminate bacteria from the formula before it was shipped for packaging, the report said. Variations in temperature should have prompted a report to a supervisor, but no notification occurred, and the formula went out to customers.
The Portland facility inspections note no official concerns from the F.D.A. In June 2022, agency inspectors at the company’s plant in Iowa swabbed the production area and found cronobacter sakazakii near the milk dryer. Inspectors pointed out “microcracks” on equipment used to dry milk, saying they could harbor bacteria and urging the company to fix them.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
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