A devastating outbreak of botulism in babies has left the US Food and Drug Administration (FDA) stumped, with the agency still unable to determine the cause or how to prevent it from happening again. The outbreak was linked to spore-contaminated formula made by ByHeart, a company that produces infant formula for vulnerable infants.
The FDA’s investigation into the root cause of the contamination is ongoing, with a focus on ingredients. Despite clear tracking of the bacteria behind the outbreak, Clostridium botulinum, which can produce hardy spores found in soil and sediments, the agency has not been able to identify where in the production chain the bacteria entered or how.
The outbreak was identified in early November and declared over by the FDA and Centers for Disease Control and Prevention on February 26. A total of 48 infants across 17 states were sickened and hospitalized, with some still recovering months after the life-threatening infection.
The investigation has revealed that 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.
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. However, despite this detailed tracking, the agency could not determine where in the production chain the bacteria entered or how.
Bill Marler, a lawyer specializing in food poisoning who is also representing 25 of the sickened infants in litigation, has expressed disappointment with the FDA’s conclusion. ‘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.
The three companies at the center of the investigation – ByHeart, Organic West Milk, and Dairy Farmers of America – have all pointed fingers at each other, with none publicly taking responsibility for the contamination. ByHeart released a statement saying that ‘FDA has shared that it did not identify any deficiencies in ByHeart’s facilities that could explain the root cause of this outbreak.’
Marler wants to see more investigation and action by the FDA to understand and prevent another outbreak from happening. He notes that sourcing, verifying, and testing what goes into infant formula is the job of manufacturers like ByHeart.
The FDA’s lack of clear guidance for consumers or companies going forward has been criticized as ‘underwhelming’ by Marler. The agency’s post-outbreak response activities have been met with disappointment from those affected by the outbreak.
In the meantime, ByHeart is working to resume infant formula production and is developing more sensitive testing for C. botulinum in its products.
Source: Original article