Preliminary tests find botulism-causing bacteria in Byheart infant formula – National

California health officials say preliminary tests have determined that Byheart infant formula contains the type of bacteria that produces toxins linked to botulism outbreaks.

The outbreak has affected at least 13 infants in 10 states. No deaths were reported.

“Consumers in possession of this product should immediately stop using it,” the California Department of Public Health said in a statement late Saturday.

Further testing of ByHeart Whole Nutrition Infant Formula is pending as state and federal health officials investigate the outbreak that began in mid-August. The New York-based company recalled two lots of its powder product this weekend.

Here's what you need to know about outbreaks and infant botulism.

Outbreak of infant botulism

An outbreak of infant botulism has affected infants aged 2 weeks to 5 months since mid-August. All were hospitalized after ingesting Byheart infant formula, according to the U.S. Centers for Disease Control and Prevention.

The cases occurred in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

According to the U.S. Food and Drug Administration, Byheart officials have agreed to recall two lots of the company's complete nutritional infant formula. This formula has a best before date of December 2026.

California health officials tested cans of powdered milk given to sick infants. The results “suggest the presence” of a type of bacteria that produces botulinum toxin, which has been identified in other cases. It may take several days for results to be confirmed.

Byhart officials said “further testing is needed” to find out if the type of bacteria that causes botulism is present. It comes from a large family of bacteria, many of which occur naturally in the environment and do not cause disease, the company said.

“We take this matter very seriously,” the company said in a statement on Sunday.

The FDA is investigating reports of 83 cases of infant botulism reported since August, including cases linked to ByHeart infant formula.

Causes of infant botulism

Infant botulism typically affects fewer than 200 infants each year in the United States. It is caused by a type of bacteria that produces toxins in the large intestine. This bacterium spreads through hardy spores present in the environment and can cause serious illness, including paralysis.

Infants under the age of 1 are particularly susceptible and can become ill if exposed to spores in dust, soil, or water, or if they eat contaminated honey.

Symptoms may take several weeks to appear and may include eating disorders, loss of head control, droopy eyelids, and a flat facial expression. Your baby may feel “fluffy” and have trouble swallowing or breathing.

Dr. Stephen Abrams, a nutrition expert at the University of Texas, said there have been no known outbreaks of infant botulism associated with formula.

“This would be extremely rare,” he says.

Treatment of infant botulism

The only treatment is known as BabyBIG, an IV drug made from the pooled plasma of adults who have been vaccinated against botulism. The California Infant Botulism Treatment and Prevention Program developed this product and is the only source worldwide.

current trends

BabyBIG is working to shorten the length of hospital stay and reduce the severity of the disease for infants with botulism. Infections can affect the ability to breathe, so infants often need to be put on a ventilator.

The CDC says all children affected by the Byheart outbreak are receiving medication.

Potential impact on U.S. baby formula supply

There is no danger of a shortage of infant formula due to this outbreak. Byheart was founded in 2016 and accounts for an estimated 1% of domestic baby formula sales, according to the CDC. The company sells baby formula on its website and in retail stores nationwide.

This is different from the crisis in late 2021 and 2022, when four infants became ill with a different bacteria after consuming formula manufactured by Abbott Nutrition. Two of the infants died. Although no direct link was found between Abbott products and infections caused by Cronobacter sakazakii, FDA officials shut down the company's Michigan plant after detecting contamination and other problems.

Mr. Abbott recalled top brands of infant formula, causing a massive national shortage that lasted for months.

In 2022, Byheart recalled five batches of infant formula after samples from its packaging plant tested positive for Cronobacter sakazakii, the bacterium at the center of the Abbott crisis. In 2023, the FDA sent the company a warning letter detailing “areas that still require corrective action.”

Reviewing the ingredients of infant formula

Federal health officials have vowed to overhaul the U.S. food supply and are taking a new look at infant formula.

Secretary of Health Robert F. Kennedy Jr. has directed the Food and Drug Administration to review the nutrients and other ingredients in the infant formula that fills the bottles of millions of American infants.

The initiative, dubbed Operation Stork Speed, is the first to take a closer look at raw materials since 1998.

FDA officials are reviewing comments from industry, health experts, and the general public to determine next steps.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. AP is solely responsible for all content.

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