Still, the FDA was unable to determine where or how the bacteria entered the production chain.
“Although there were several hypotheses, the findings failed to identify the source or root cause of the contamination of the powdered infant formula,” the agency concluded.
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Bill Marler, a food poisoning lawyer who represented 25 of the sick babies in the lawsuit, told Ars that the outcome was “a little difficult to say the least.” The epilogue, titled “Post-Press Response Actions,” the FDA posted this week offered a summary “without any real clear guidance for consumers or companies moving forward.”
Meanwhile, each of the three companies escapes blame. ByHeart released a statement this week saying, “The FDA shared that it has not identified any deficiencies in ByHeart’s facilities that could explain the underlying cause of this occurrence.”
Bill Van Ryn, owner of Organic West Milk, emphasized before The media reports that “nothing has been proven about our milk yet.” Likewise, the Dairy Farmers of America blamed Organic West, saying its processing met all required tests. “Manufacturers of consumer end-use products have a responsibility to properly process ingredients to ensure product safety,” said Dairy Farmers of America. statement.
While Marler wants more research and action by the FDA to understand and prevent another outbreak from happening, the blame ultimately lies with ByHeart, he says. It’s “not just an ingredient issue that goes through ByHeart. It’s a ByHeart product, in a ByHeart box, with the ByHeart name on it, being fed to a baby,” he wrote in a recent blog post. “Acquiring, inspecting and testing what goes into infant formula is work.”
Marler also noted that this is not the first time Infant botulism is associated with infant formula.
In a statement this week, ByHeart said it was working to resume production of its infant formula. The company is now working with a lab to develop more sensitive tests C. botulinum in their products.
