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Underwhelming

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

In the end, the three companies involved all point the finger at each other.

Beth Mole – | 65
a container of byheart baby formula
Credit: ByHeart
Credit: ByHeart
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The Food and Drug Administration this week posted what critics call an “underwhelming” epilogue to the devastating outbreak of botulism in babies, which was linked to spore-contaminated formula made by ByHeart. Despite clear tracking of the contamination, the regulator still doesn’t know how the bacteria arrived in the formula—or how to prevent it from happening again.

“The FDA’s investigation into the root cause is ongoing with a focus on ingredients,” the agency reported.

In the void, three companies at the center of the investigation are left pointing fingers at each other, with none publicly taking responsibility for the contamination.

The outbreak was identified in early November and was declared over by the FDA and Centers for Disease Control and Prevention on February 26. In the end, 48 infants across 17 states were sickened and hospitalized. Some are still recovering months after the life-threatening infection.

The FDA’s investigation provided a detailed trace of the bacteria behind the outbreak, Clostridium botulinum, which can produce hardy spores that are found in soil and sediments. If the spores reach an amenable environment—such as the vulnerable, underdeveloped guts of infants—they begin to grow and produce a neurotoxin that causes flaccid paralysis.

Strains of C. botulinum isolated from some of the sick infants were genetically linked to strains found in ByHeart’s formula, which were also linked to strains found in powdered whole milk used in the formula. The powdered whole milk was dried from liquid milk at a Nevada facility run by Dairy Farmers of America, and the liquid milk came from the supplier Organic West, based in California. Organic West sold the resulting powder to ByHeart.

Specifically, the FDA traced contaminated formula and milk powder back to eight whole milk lot powders that came from 33 fluid milk lots from Organic West, according to an incident summary.

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

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

Finger-pointing

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

In the meantime, each of the three companies is shirking blame. ByHeart released a statement this week saying “FDA has shared that it did not identify any deficiencies in ByHeart’s facilities that could explain the root cause of this outbreak.”

Bill Van Ryn, an owner of Organic West Milk, previously stressed in media reports that “nothing has been proven about our milk yet.” Likewise, Dairy Farmers of America blamed Organic West, saying its processing met 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 wants to see more investigation and action by the FDA to understand and prevent another outbreak from happening, the blame ultimately lies with ByHeart, he says. It’s “not only an ingredient problem that happened to pass through ByHeart. That is ByHeart’s product, in ByHeart’s can, with ByHeart’s name on it, fed to a baby,” he wrote in a recent blog post. “Sourcing, verifying, and testing what goes into infant formula is the job.”

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

In its statement this week, ByHeart said it is working to resume infant formula production. The company is now working with a lab to develop more sensitive testing for C. botulinum in its products.

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Beth Mole Senior Health Reporter
Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.
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