The United States is in the grip of a botulism outbreak linked to a premium baby food brand. At least 23 infants were injured.
According to research firm ByHeart, all reported cases of the paralyzing bacterial infection occurred between August and November and were associated with the use of ByHeart's powdered infant formula. Food and Drug Administration Report. The company voluntarily recalled all of its products on November 11, and experts warn that more cases of the potentially fatal disease could arise.
“In some cases, after infection, it could take up to a month for some infants to actually show symptoms,” says Randal De Souza, a pediatric infectious disease specialist at the University of Kentucky Golisano Children's Hospital.
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FDA and Centers for Disease Control and Prevention is currently studying the disease in children from 13 states: Arizona, California, Illinois, Kentucky, Michigan, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas and Washington State..
In an email to Scientific American ByHeart co-founder and president Mia Fant said the company is working with the FDA and independent experts on the recall and ongoing investigations.
“Our number one priority is the health of babies. We extend our deepest sympathies to the families currently suffering from cases of infant botulism,” Fant wrote. The FDA did not immediately respond to a request for comment Scientific American.
Here's what you need to know about the outbreak and how to stay safe.
What you need to know about an outbreak of botulism in infants
Botulism is a relatively rare but potentially serious infection caused by a soil bacterium. Clostridium botulinum. According to De Souza, the bacterium produces toxins that damage nerves. According to the most recent data from the Center for Disease Control and Prevention (CDC)There have been 243 laboratory-confirmed cases in the United States in 2021, and 181 of these infections occurred in infants. Between 5 and 10 percent of cases are fatal.
In infants, the first signs of infection are usually constipation, followed by varying degrees of paralysis. At first, babies may lose control of their facial expressions, mouth, and eyes. They may also drool more, feed longer or cry less, De Souza said. He explains that the paralysis slowly spreads throughout the body.
“The presentation tends to be 'floppy baby,' which essentially means that first you lose control of your head, then you lose control of your limbs, and the last thing is usually breathing: you lose the ability to breathe,” De Souza says.
How are infected infants diagnosed and treated?
Clinical diagnosis using stool samples can take up to a week, so any infant suspected of having botulism should be closely monitored, De Souza says.
If infants are hospitalized, they are placed on feeding tubes and may be intubated. Infections are treated with an antitoxin, which binds and neutralizes excess toxins in the body to stop the infection.
“The body then has to essentially regenerate the nerves,” says De Souza. This process may take weeks or months, and some children may require additional speech therapy or feeding adjustments. In extreme cases, they may require a breathing tube.
Babies recovering from botulism do not have ongoing problems, De Souza said, but “a very young child requiring months of support is not a good thing.”
All 23 infants infected in the recent outbreak (almost all of whom are now under seven months old) were hospitalized, and no deaths were reported.
How to Stay Safe
ByHeart and the FDA are warning people not to use newly purchased ByHeart infant formula. Barbara Kowalczyk, director of the Institute for Food Safety and Nutrition at George Washington University, advises checking any ByHeart formulas parents may have stocked up on.
“People have things in their pantries that they don't necessarily know about or may not have heard about the recall,” Kowalczyk says. “The language of a voluntary recall could lead people to potentially believe it’s not such a big deal.”
She suspects more cases of botulism will be identified in the coming weeks.
Is infant formula particularly susceptible to botulism?
There was botulism found earlier in infant formula. The pathogen mainly exists as resistant spores, and while high pressure or high temperature at an industrial level can kill it, “regular heating in, say, a home kitchen won't,” De Souza says. Otherwise, “the disputes will live forever.”
Since August, 84 infants in the United States have been treated for botulism, and 36 of those cases were associated with exposure to powdered infant formula, according to the Infant Botulism Treatment and Prevention Program (IBTPP).
It's unclear if C. botulinum contamination occurred at any stage of the manufacturing process at ByHeart facilities, in stores where the products were sold, or in people's homes after the process. California Department of Public Health reported on November 8 that an already opened jar of ByHeart formula tested positive for C. botulinum and officials are now testing unopened foods for the presence of the bacteria.
In the open letter to FDAByHart referred to a broader “unprecedented surge” in infant botulism nationwide. IBTPP representatives also said that the surge in cases may indicate broader trendAssociated Press reports..
Other bacteria can also contaminate baby formula. In 2022, ByHeart recalled products due to contamination Cronobacter Sakazaki, a pathogen that can cause fatal infections in infants. In 2023, the company ceased formula production at its Pennsylvania plant due to a number of security breaches, according to the FDA. ByHeart told Scientific American that the Pennsylvania plant has not produced infant formula since 2023 and is not related to the current recall.
In 2022 and 2023, Abbott and Reckitt/Mead Johnson Nutrition, the country's two largest infant formula makers, were at center of large national deficits after voluntary withdrawal from S. sakazakii detection. ByHeart products make up about 1 percent of all infant formula sold in the United States, according to the FDA. Kowalczyk doesn't expect the ByHeart recall to cause a similar shortage, but she says the incident does reflect a more troubling trend in food safety supervision.
“I think historically there has been a tendency to argue that low-moisture foods are not ideal environments for pathogens to grow,” she says. “And with these recent outbreaks, we're going to have to rethink that.”
