Still, the FDA could not determine where in the production chain the bacteria entered or how.
“Although several hypotheses exist, the results of the investigation could not identify the source or root cause of the contamination of powdered infant formula,” the agency concluded.
Point
Bill Marler, a food poisoning attorney who also represents 25 of the sick babies in the litigation, told Ars that the conclusion is “a little disappointing, to put it mildly.” The afterword the FDA released this week, titled “Post-Outbreak Response Activities,” provided a summary “without any really clear guidance for consumers or for businesses going forward.”
Meanwhile, each of the three companies deflects blame. ByHeart issued a statement this week saying that “the FDA has shared that it did not identify any deficiencies at ByHeart’s facilities that could explain the root cause of this outbreak.”
Bill Van Ryn, owner of Organic West Milk, previously stressed In the media it is reported that “nothing has been proven about our milk yet.” Likewise, Dairy Farmers of America blamed Organic West, saying its processing met all required testing. “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 wants to see more investigation and action by the FDA to understand and prevent another outbreak from occurring, the blame ultimately falls on ByHeart, he says. “It’s not just an ingredient issue that happened with ByHeart. That’s the ByHeart product, in the ByHeart can, under the ByHeart name, given to a baby,” he wrote in a recent blog post. “The job is to obtain, verify and test what goes into infant formula.”
Marler also noted that this is not the first time Infant botulism has been linked to infant formulas..
In its statement this week, ByHeart said it is working to resume production of infant formula. The company is now working with a laboratory to develop more sensitive tests for C. botulinum in their products.
