\n<\/p>\n
The U.S. is in the grips of a botulism outbreak tied to a premium infant formula brand. At least 23 babies have been affected.<\/p>\n
All the reported cases of the paralyzing bacterial infection occurred between August and November and have been linked to powdered infant formula produced by ByHeart, according to a Food and Drug Administration report. The company voluntarily recalled all its products on November 11, and experts caution that more cases of the potentially fatal disease may surface.<\/p>\n
\u201cIn some cases, after exposure, it may have taken up to a month for some babies to actually show symptoms,\u201d says Randal De Souza, a pediatric infectious disease specialist at Golisano Children\u2019s Hospital at the University of Kentucky.<\/p>\n
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The FDA and the Centers for Disease and Control and Prevention are currently investigating illnesses in babies from 13 states: Arizona, California, Illinois, Kentucky, Michigan, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas and Washington State.<\/p>\n
In an e-mail to Scientific American, ByHeart\u2019s co-founder and president Mia Funt said the company was working with the FDA and independent experts on its product recall and ongoing investigations.<\/p>\n
\u201cOur number one priority is infant health. We express our deepest sympathy to the families currently impacted by the cases of infant botulism,\u201d Funt wrote . The FDA did not immediately respond to a request for comment from Scientific American.<\/p>\n
Here\u2019s what to know about the outbreak and how to stay safe.<\/p>\n
Botulism is a relatively rare but potentially severe infection caused by the soil-dwelling bacterium Clostridium botulinum. The bacterium produces toxins that damage nerves, De Souza says. According to the most recent CDC data, there were 243 lab-confirmed cases in the U.S. in 2021, and 181 of those infections were in infants. Between 5 and 10 percent of cases are fatal.<\/p>\n
In infants, the first signs of infection are usually constipation, followed by varying degrees of paralysis. Babies might initially lose control of their facial expressions, mouth and eyes. They might also drool more, take longer to feed or have a weaker cry, De Souza says. The paralysis slowly progresses down through the body, he explains.<\/p>\n
\u201cThe presentation tends to be a \u2018floppy baby,\u2019 which essentially means you lose head control first, then you lose limb control, and the last tends to be respiration: you lose your ability to breathe,\u201d De Souza says.<\/p>\n
A clinical diagnosis, using stool samples, can take up to a week, so any infant with a suspected case of botulism must be monitored closely, De Souza says.<\/p>\n
If infants are hospitalized, they are placed on feeding tubes and may be intubated. Infections are treated with an antitoxin that binds to and neutralizes excess toxins in the body to stop the infection.<\/p>\n
\u201cThen it\u2019s up to the body to essentially regenerate nerves,\u201d De Souza says. That process can take weeks or months, and some babies may require further speech or feeding therapy. In extreme cases, they might require a breathing tube.<\/p>\n
Infants who recover from botulism aren\u2019t known to have permanent issues, De Souza says, but \u201ca very young baby requiring multiple support modalities for months is not great.\u201d<\/p>\n
All 23 infants that were infected in the recent outbreak\u2014almost all of whom are currently under seven months old\u2014have been hospitalized, and no deaths have been reported.<\/p>\n
ByHeart and the FDA are alerting people not to use recently purchased ByHeart infant formula. Barbara Kowalcyk, director of the Institute for Food Safety and Nutrition Security at George Washington University, says to check any ByHeart formula parents might have stocked up.<\/p>\n
\u201cPeople have stuff in their pantries that they don\u2019t always know about, or they may not hear about the recall,\u201d Kowalcyk says. \u201cThe voluntary recall language can lead people to potentially believe that it\u2019s not as big of an issue.\u201d<\/p>\n
She suspects that more cases of botulism will be uncovered in the coming weeks.<\/p>\n
Botulism has been detected in baby formula before. The pathogen mostly exists as a hardy spore, and while high pressure or heat at an industry level can kill them, \u201cyour typical heating, say, in your home kitchen will not,\u201d De Souza says. Otherwise, \u201cthe spores just live forever.\u201d<\/p>\n
According to the Infant Botulism Treatment and Prevention Program (IBTPP), 84 infants in the U.S. have received treatment for botulism since August\u2014and 36 of those cases have been linked to powdered infant formula exposure.<\/p>\n
It\u2019s unclear if C. botulinum contamination occurred at any point during the manufacturing process at ByHeart\u2019s facilities or at stores that sold the product or in people\u2019s homes after that process. The California Department of Public Health reported on November 8 that an already opened can of ByHeart formula tested positive for C. botulinum, and officials are now testing unopened products for the bacterium.<\/p>\n
In an open letter to the FDA, ByHeart alluded to a wider \u201cunprecedented spike\u201d in national infant botulism. Representatives of IBTPP have also said that the spike in cases may be indicative of a broader trend, the Associated Press reported.<\/p>\n
Other bacteria can also contaminate infant formula. In 2022 ByHeart recalled products because of contamination with Cronobacter sakazakii, a pathogen that can cause deadly infections in infants. In 2023 the company stopped producing formula at a Pennsylvania facility because of several safety violations, according to the FDA. ByHeart told Scientific American that the Pennsylvania facility has not produced infant formula since 2023 and is not connected with the current recall.<\/p>\n
In 2022 and 2023 Abbott and Reckitt\/Mead Johnson Nutrition, two of the country\u2019s biggest infant formula manufacturers, were at the center of major national shortages after putting out voluntary recalls from C. sakazakii detections. ByHeart\u2019s products make up approximately 1 percent of all infant formula sold in the U.S., according to the FDA. Kowalcyk doesn\u2019t anticipate that ByHeart\u2019s recall will trigger a similar shortage, but she says the incident does reflect a larger worrisome trend in food safety surveillance.<\/p>\n
\u201cI think, historically, there has been this tendency to say low-moisture foods aren\u2019t a great environment for pathogens to grow in,\u201d she says. \u201cAnd with these recent outbreaks, we\u2019re having to rethink that.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"
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