How does infant formula get contaminated with botulism?
Contamination can occur in various stages of production, Northeastern expert says about infant formula botulism outbreak.
Note: The number of infants and states affected was updated Nov. 14 with new information from the Food and Drug Administration.
Federal officials are investigating an 11-state outbreak of infant botulism that has sickened 23 babies who consumed ByHeart Whole Nutrition Infant Formula.
The U.S. Food and Drug Administration said ByHeart has agreed to voluntarily recall two lots of the powdered formula and asked parents to throw the products away immediately. No infant deaths have been associated with the outbreak, according to the agency.
Botulism from powdered formula is rare but especially dangerous when it occurs, says Darin Detwiler, Northeastern professor and food policy safety expert.
Especially dangerous for infants
Botulism is caused by a neurotoxin produced by the Clostridium bolinum bacterium, Detwiler says, warning that “even small amounts of the toxin can be life threatening.”
“Symptoms typically begin with weakness, blurred vision, difficulty swallowing and muscle paralysis,” he says. The FDA says symptoms in babies also include poor feeding, loss of head control and decreased facial expression.
Infants are especially vulnerable to botulism, Detwiler says.
While adults typically get botulism from ingesting the neurotoxin in contaminated food, infants get sick from consuming the bacterial spores, he says.
“Their gut microbiomes are not yet developed to prevent the growth of C. botulinum spores, which can germinate and produce toxin directly in their intestines,” Detwiler says. “This is why health authorities advise against giving honey to infants under one year of age, as honey can contain these spores.”
How contamination occurs
The FDA says it is investigating to determine at what point the infant formula was contaminated and whether any additional products are affected.
Detwiler says federal and state public health officials likely will be looking at multiple potential pathways.
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During production, spores or pathogens can enter during production if equipment is not adequately sanitized, or in packaging if the formula comes in contact with airborne contaminants or unclean surfaces containing bacteria.
Preparation at home or in hospitals can occur if caregivers use non-sterile water or unclean bottles, Detwiler says.
“Clostridium botulinum forms spores that are incredibly resilient, surviving in dry environments for long periods,” he says. “If those spores find a moist, low-oxygen environment, like mixed formula in a bottle, they can grow and produce toxins.”
“Even a single lapse in process control — like a crack in a pipe or insufficient cleaning — can lead to botulism contamination,” Detwiler says. “If a facility doesn’t have strict controls on moisture and cleanliness, spores can persist.”
Role of FDA
While the FDA is the primary regulatory body overseeing infant formula production in America, powdered formula “is still exempt from some sterility standards required for other medical foods,” a cause for concern among some food policy experts, Detwiler says.Though infant formula has rarely been associated with botulism, “the risk is not zero and the potential severity makes it critical to treat any suspicion with urgency,” he says.
