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As the nationwide outbreak of infant botulism continues to grow, and new test results show botulism bacteria in some samples of ByHeart infant formula, the source of the potentially deadly contamination remains unknown.
ByHeart Inc., in an announcement on its website Wednesday night, said that testing the company commissioned has identified Clostridium botulinum, the bacteria that cause botulism, in some samples of its baby formula.
“We do not yet know the root cause, but we are committed to finding the answers,” the company said.
At least 31 infants in 15 states who have been fed ByHeart Whole Nutrition infant formula have been hospitalized with suspected or confirmed infant botulism as of Wednesday, according to the U.S. Food and Drug Administration (FDA).
That’s eight more infants since Friday’s outbreak update. It can take up to 30 days between when a baby ingests botulism spores until they start showing signs of illness.
Meanwhile, despite the outbreak and nationwide recall of all ByHeart products, FDA officials on Thursday warned that the company’s products are still being sold in multiple states. The FDA said the formula has been reported at “multiple Walmart, Target, and Kroger locations, and at one or more Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s, and Star Market locations.”
Here’s what to know about the latest developments in the outbreak investigation,
How Did ByHeart Formula Become Contaminated With Botulism Spores?
Federal investigators have said little about how they suspect ByHeart’s infant formula became contaminated, and they have released few details about what their investigation of ingredients and manufacturing processes have found.
“The contaminant is the spores, Clostridium botulinum spores,” said David Clark, a dairy product industry consultant whose practice specializes in infant formulas. “It’s very important to find out where the spores are coming from, because it’s difficult to eliminate them, to kill them, to prevent them from germinating into active bacteria.”
Pasteurization of milk does not occur at a high enough temperature to kill botulinum spores, which is why it’s important to prevent them from getting into milk, he said.
Infant botulism is caused by babies ingesting these inactive spores. But once the spores are in the body, they germinate and colonize the infant’s intestine, where they produce a neurotoxin. The infant may not have any symptoms until weeks after exposure, then begin to show signs of constipation, loss of head control, and difficulty sucking and feeding.
As federal investigators and ByHeart continue to look for how bacteria spores got into the formula, Clark said there are a wide range of ingredients and manufacturing processes that are likely being scrutinized.
Clark, whose firm Bovina Mountain Consulting is based in Englewood, Fla., told Healthbeat it’s important to keep an open mind about where the spores might be coming from,