Congresswoman demands that FDA release all inspection reports on ByHeart infant formula production plants
A U.S. official is pressing the FDA for information on ByHeart Inc., the company linked to an outbreak of childhood botulism poisonings.
In a letter to FDA Administrator Marty Makary, Rep. Rosa DeLauro, D-CT, demanded that all inspection records from the company’s infant formula manufacturing plants be released to Congress. Plants are located in Reading, PA, Allerton, IA and Portland, OR.
DeLauro cites media reports that ByHeart closed one of the plants earlier this year after Food and Drug Administration inspectors discovered multiple food safety violations, including a leaking roof and more than 2,500 dead insects in a production area.
“The FDA has rated the inspection as its 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 to their children is safe.”
“Due to the urgent nature of this matter, I am requesting this information by Wednesday, November 19.”
The infant botulism outbreak has sickened 24 babies in 13 states, according to the FDA and the Centers for Disease Control and Prevention. All the babies had to be hospitalized. Earlier this month, public health officials informed ByHeart founder and CEO Ron Belldegrun that there had been at least 84 cases of childhood botulinum poisoning since August. 1.
Dr. Erica Pan, California’s top public health official, said The New York Times that the department noticed an increase in reports starting August 1. Of about 84 infants treated for botulism, she said, about 36 were fed formula, including at least 15 who ingested ByHeart formula. Federal health officials say there are only about 130 to 150 cases of childhood botulinum poisoning each year, making the number of cases since Aug. 1 likely come from the same source.
The California Department of Health collected an open box of ByHeart formula from the home of a patient, who tested positive for the outbreak strain of botulism.
ByHeart has recalled all of its baby formula products, including cans and single-serve bags. On November 15, the Canadian Food Inspection Agency warned consumers in this country not to feed infants ByHeart formula due to the U.S. recall and outbreak in the United States.
Problems at a ByHeart production facility have been going on since at least 2022, according to an FDA warning letter sent to the company on August 2, 2023.
In the warning letter, the FDA pointed out that the company did not have a process control system in place designed to ensure that infant formula in the production facility was not contaminated with microorganisms. The FDA also noted that on October 22, 2022, the company reported to (redacted) that a batch of ByHeart formula had tested positive for Cronobacter. Cronobacter can cause serious infections in babies, often fatal.
Initially, the positive test result showing Cronobacter contamination was considered a laboratory error, but further investigation showed that this was not the case.
“The third-party laboratory provided an ‘Investigation Report on OOS Results for Microbiological Testing’ regarding the findings of Cronobacter sakazakii in the finished product, which concluded that ‘the laboratory error was not found or substantiated,'” according to the warning letter.
“The third-party laboratory reached this conclusion after reviewing its internal protocols and testing conditions, finding no basis to attribute the sample results to a laboratory error. Typically, a finding of laboratory error in an RCA is supported by confirmed evidence, such as a written confirmation from the third-party laboratory attesting to the error. Here, there is no attestation; there is evidence to the contrary.
“Despite the discrepancy between the third-party laboratory and the internal conclusion of the (redacted) root cause analysis, neither you nor your subsidiary (redacted) made additional efforts to evaluate other pathways of contamination that may have contributed to this event. Our review of your records obtained during the (redacted) inspection shows that you did not work with your third-party contract manufacturer to further investigate the origin or root causes of the positive finished product results. As the parent company and entity manufacturing all product disposal decisions, it is your responsibility to investigate all aspects of the production process for your products, including operations conducted at your (redacted) facility and that of your third-party contract manufacturer, when evaluating the potential root cause(s) of a product contamination event.
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