ATLANTA (AP) - The U.S. Centers for Disease Control and Prevention (CDC) announced on Thursday that a rare outbreak of infant botulism, which affected dozens of infants who consumed recalled ByHeart formula, is now over. No new cases have been reported since mid-December 2023.
In total, 48 infants were reported sick since the beginning of 2023. The case count was slightly reduced as three infants were later found to have other illnesses unrelated to botulism, according to health officials. All affected children were hospitalized, but fortunately, no fatalities have been documented.
The exact cause, timeline, and location of the contamination in the organic, whole-milk powdered baby formula remain unclear. Health officials pointed out that many of the cases emerged after August when California's Infant Botulism Treatment and Prevention program observed a concerning increase in illness reports among babies consuming ByHeart formula.
Based in New York, ByHeart initially recalled two lots of its formula in early November 2023. However, due to escalating concerns, the company expanded the recall to include all products only days later. Federal health authorities indicated they could not dismiss the possibility of contamination in products manufactured since ByHeart's launch in March 2022. Consequently, stores nationwide removed the formula from their shelves, which was marketed as offering "next-to-breast milk benefits."
Investigators from the U.S. Food and Drug Administration (FDA) are still working to pinpoint the source of the contamination. The agency reported that 17 different strains of the bacteria responsible for botulism were discovered in samples collected from patients, completed cans of formula, and its ingredients. While these samples are contributing to the investigation, the FDA has clarified that they are not definitive evidence of contamination.
Previously, FDA officials suggested that the powdered whole milk used in ByHeart infant formula might be a potential source of the outbreak. It's important to note that illnesses caused by botulism bacteria in infant formula are generally rare; however, the scale of the ByHeart outbreak is unprecedented, as highlighted by food safety experts.
Botulism occurs when infants ingest spores that lead to toxin production in the intestines, affecting the nervous system. While death rates from the disease once reached as high as 90%, advancements in treatment have reduced this figure to below 1% today.
The only available treatment for infant botulism is intravenous medication known as BabyBIG, made from pooled blood plasma of adults immunized against botulism. California's program remains the sole source of this treatment worldwide.
Before the outbreak, ByHeart held approximately 1% of the U.S. infant formula market, selling around 200,000 cans each month. Many parents chose this formula, priced at about $42 per can, due to its claimed health benefits.
