CALIFORNIA — The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) declared an infant botulism outbreak over on February 26. The outbreak sickened 48 infants across 17 states, all of whom were hospitalized.
The outbreak was traced to specific milk powder lots used in ByHeart infant formula. Genetic testing linked Clostridium botulinum strains isolated from infected infants to strains found in ByHeart infant formula. Evidence also connected Clostridium botulinum strains in the ByHeart formula to strains identified in the powdered whole milk used to manufacture the product.
The FDA's investigation into the root cause of contamination focuses on ingredients. The agency traced the contaminated infant formula and milk powder to eight whole milk powder lots, which originated from 33 fluid milk lots supplied by Organic West. Dairy Farmers of America processed liquid milk from Organic West into powdered whole milk at a facility in Nevada. Organic West then sold the milk powder to ByHeart.
In a report titled "Post-Outbreak Response Activities," the FDA concluded, "Even though there are several hypotheses, investigational findings could not identify the source or root cause of contamination of the powdered infant formula."
ByHeart stated, "FDA has shared that it did not identify any deficiencies in ByHeart's facilities that could explain the root cause of this outbreak." The company is currently working with a laboratory to develop more sensitive testing methods for detecting Clostridium botulinum in its products and is undertaking steps to resume infant formula production.
Attorney Bill Marler, who represents 25 of the sickened infants in ongoing litigation, addressed responsibility for the product. Marler stated, "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." Clostridium botulinum produces spores commonly found in soil and sediment; when these spores germinate in an infant's digestive system, they release a neurotoxin that causes flaccid paralysis.