A US official is pressing the FDA to provide information about ByHeart Inc., a company linked to an outbreak of childhood botulism poisoning.
In a letter to FDA Administrator Marty Macari, Rep. Rosa DeLauro, D-Conn., demanded that all inspection reports of the infant formula company's plants be turned over to Congress. Plants are located in Reading, Pennsylvania, Allerton, Iowa, and Portland, Oregon.
DeLauro cites media reports that ByHeart closed one of its plants earlier this year after Food and Drug Administration inspectors found numerous food safety violations, including a leaking roof and more than 2,500 dead insects in the production area.
“The FDA has classified the review as the highest level of concern. This report raises serious concerns about the company's food safety record,” DeLauro wrote.
“It's time for transparency. American parents deserve to know that the formula they give their children is safe.
“Due to the urgency of this matter, I am requesting this information by Wednesday, November 19.”
The infant botulism outbreak has affected 24 infants in 13 states, according to the FDA and Centers for Disease Control and Prevention. All babies had to be hospitalized. Earlier this month, public health officials notified ByHeart founder and CEO Ron Belldegrun that there had been at least 84 cases of childhood botulism poisoning since August. 1.
Dr. Erica Pan, California's chief public health officer, said: New York Times that the department noticed an increase in the number of reports starting on August 1st. Of the approximately 84 infants treated for botulism, about 36 received formula, including at least 15 who received ByHeart formula, she said. Federal health officials say there are only 130 to 150 cases of infant botulism poisoning reported each year, so the number of cases since Aug. 1 likely comes from the same source.
The California Department of Public Health removed an open can of ByHeart formula from a patient's home that tested positive for the strain of botulism causing the outbreak.
ByHeart remembered all its products, including cans and disposable bags. The Canadian Food Inspection Agency on Nov. 15 warned consumers in that country not to feed ByHeart food products to children due to a U.S. recall and outbreak in the United States.
Problems at the ByHeart manufacturing plant have been ongoing since at least 2022, according to the agency. FDA Warning Letter sent to the company on August 2, 2023.
In the warning letter, the FDA said the company had not established a process control system to ensure that baby food at the manufacturing plant was not contaminated with microorganisms. The FDA also noted that on October 22, 2022, the company reported (redacted) that a batch of ByHeart formula tested positive for Cronobacter. Cronobacter can cause serious infections in infants that are often fatal.
The positive test result, indicating Cronobacter infection, was initially thought to be a laboratory error, but further investigation revealed that this was not the case.
“The third-party laboratory provided an “OOS Microbiological Testing Results Report” regarding detections of Cronobacter sakazakii in the finished product, which concluded that “a laboratory error was not detected or confirmed,” according to the warning letter.
“The third-party laboratory reached this conclusion after reviewing its internal protocols and testing conditions and found no basis to attribute the sample results to a laboratory error. Typically, a finding of laboratory error under an RCA is supported by corroborated evidence, such as written confirmation from the third-party laboratory confirming the error. In this case, there is no corroboration; there is evidence to the contrary.
“Despite the discrepancy between the third-party laboratory results and the internal determination of the (redacted) root cause analysis, neither you nor your subsidiary (redacted) made any additional efforts to evaluate other contamination pathways that may have contributed to this event. Our review of your records obtained during the (redacted) audit indicates that you did not work with your third-party contract manufacturer to further investigate the origin(s) or root cause(s) of the finished product, positive results. How parent company and the organization that manufactures all products When making disposal decisions, you have a responsibility to investigate all aspects of your product's manufacturing process, including operations at your (redacted) facility and at your third-party contract manufacturer's facility, when assessing the potential root cause of a product contamination event.”
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