Baby botulism outbreak: FDA still doesn’t know cause—or how to prevent it

Still, the FDA could not determine where or how the bacteria entered the production chain.

The agency concluded, “Although there are several hypotheses, the findings of the investigation could not identify the source or root cause of the contamination of the powdered infant formula.”

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Bill Marler, a lawyer specializing in food poisoning who is also representing 25 of the sick infants in the lawsuit, told Ars that the findings are “a little weak to put it mildly.” The epilogue the FDA posted this week, titled “Post-Outbreak Response Activities,” provided a summary “without any real clear guidance for consumers or for companies moving forward.”

Meanwhile, each of the three companies is avoiding blame. BayHeart released a statement this week saying, “The FDA shared that it has not identified any deficiencies at BayHeart’s facilities that could explain the root cause of this outbreak.”

Bill Van Ryn, owner of Organic Waste Milk, previously insisted in media reports that “Nothing has been proven yet about our milk.” Similarly, US dairy farmers blame organic waste, saying its processing passes all required tests. “Manufacturers of end-use consumer products have a responsibility to properly process ingredients to ensure product safety,” Dairy Farmers of America said in a statement.

While Marler would like to see more investigation and action by the FDA to understand and prevent another outbreak from happening, he says the blame ultimately lies with Bayheart. “This is not just an ingredient problem that Bayheart has gone through. This is a Bayheart product, in a Bayheart can, with the Bayheart name on it, fed to a child,” he wrote in a recent blog post. “The work is sourcing, verifying and testing what goes into infant formula.”

Marler also said this is not the first time that infant botulism has been linked to infant formula.

In its statement this week, Bayheart said it was working to restart infant formula production. The company is now working with a laboratory to develop a more sensitive test C. botulinum In its products.