GoKawiilThe 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.