By Donna Campisano, specialist, Communications, APHL

Federal, state and local partners, including the US Centers for Disease Control and Prevention (CDC), the California Department of  Public Health (CDPH) Infant Botulism Treatment and Prevention Program (IBTPP) and the US Food and Drug Administration (FDA) are investigating a multistate outbreak of infant botulism that, in preliminary testing, has been linked to the use of ByHeart Whole Nutrition Infant Formula. 

To date, 23 infants in 13 states have been sickened and hospitalized with infant botulism, a rare disease that occurs when a baby swallows Clostridium botulinum (C. botulinum) spores that then grow in the gut and create a toxin. The affected babies range in age from 2 weeks to roughly 7 months. No deaths have been reported and ByHeart has voluntarily recalled all batches of their product.  

What prompted the investigation? 

All cases of suspected infant botulism (even those in other countries) are routed to CDPH’s IBTPP, which is the world’s only source of the FDA-approved treatment for infant botulism. Officials at IBTPP observed an increase in infant botulism cases linked to powdered baby formula, and in particular, ByHeart Whole Nutrition Infant Formula. The number of babies fed ByHeart formula with confirmed or suspected cases of infant botulism is disproportionate, say officials, considering that the company holds only 1% of the powdered infant formula market share.  

Inside the laboratory 

With a suspected product identified and linked to a possible life-threatening condition, state and federal partners sprang into action.  

Laboratory scientists at the California State Public Health Laboratory (CA PHL) tested an open can of the ByHeart powdered formula that was fed to a baby with infant botulism. Their quick action helped prompt the recall, saving more babies from getting sick with this potentially deadly condition. 

The presence of botulinum neurotoxin-producing Clostridium spores was detected by the toxin neutralization test, followed by culture of the Clostridium organism and PCR confirmation of toxin-producing C. botulinum. Upon further growth in bacterial culture in the coming weeks, the CA PHL will perform whole genome sequencing (WGS) to determine if the patient and product isolates share a similar toxin type and genetic profile. 

The testing performed in California is unique and highly specialized. The laboratory scientists pulled a needle out of a haystack with their findings. FDA cautioned that detecting C. botulinum in infant formula can be difficult, and a negative test result does not necessarily rule out the presence of the bacterium in the product.  

As for the babies, testing for infant botulism is a two-step process, said APHL’s Shari Shea, senior director, Food Safety. In the first step, using specialized techniques, a toxin analysis is performed on a stool sample taken from the sick infant. In the second step, C. botulinum is grown from the stool using specialized media and techniques, but results can take a week to about one month, said Shea, who emphasized that healthcare providers should not wait for laboratory results before treating infants.  

“Some state public health laboratories perform a PCR test for the initial screening for C. botulinum toxin, while many submit specimens to CDC,” she added. “Even fewer state laboratories perform the confirmatory toxin neutralization assay. WGS of isolates tells investigators if human cases are likely to be caused by a common exposure. Are their genomic sequences alike? Sequences from powdered infant formula can also be compared to patient isolates. If the formula that was tested came from an unopened canister, this tells investigators the contamination occurred at the plant or somewhere along the production or transportation chain.”  

How did the formula get contaminated? 

That’s the million-dollar question—and yet to be answered. 

FDA investigators have visited the ByHeart production plant to review records, inspect the facility and take “retained” samples of the formula. “These ‘retained’ samples are portions of the product held by the company for situations just like this—when a hazard is found after a food product has gone to market,” explained Shea. “This is a normal safety step taken by most food producers.” 

The investigation is still ongoing, and results have not been released. 

“A very important question is why hazard reduction steps taken during the manufacturing process did not eliminate the risks from this pathogen before it reached consumers,” Shea said. “The point of outbreak investigations is not to recall products, though that is important for immediate protection of public health. The long-term goal is to find out what went wrong, how it went wrong, why it wasn’t prevented and how we can stop it from happening again.” 

C. botulinum is commonly found in the environment, especially in soil and dust. ByHeart has stated that no C. botulinum has been found in unopened cans of its product. As noted above, laboratory testing takes time, and this public health investigation is ongoing.  

What should parents do? 

ByHeart Whole Nutrition Formula was sold online and at major retailers throughout the nation. If you have fed your baby the formula, stop using it immediately. Do not throw the can away. Instead, label it “NOT FOR USE” and keep it in a safe place for at least a month. If your baby does develop symptoms of infant botulism—which include constipation, poor muscle tone, feeding problems and difficulty swallowing and breathing—investigators in your state may want to test the product. 

If you suspect your child may have infant botulism, seek medical care immediately. Infant botulism can be deadly if not treated promptly. IBTPP makes BabyBIG, the only FDA-approved treatment for infant botulism.  

“Rapid medical consultation, followed by hospitalization for supportive care and administration of BabyBIG, leads to excellent long-term prognosis,” Shea said. “Recovery results from regrowth of the nerve endings over several weeks, meaning infant botulism patients usually return to their normal health and fitness after what can be an extended and heart-wrenching experience for parents.” 

The post A Multistate Outbreak of Infant Botulism Has Been Linked to Baby Formula: What We Know So Far—and How Laboratories Are Responding  appeared first on APHL Blog.

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