Federal health officials have expanded the investigation into an outbreak of infant botulism linked to ByHeart baby formula. The U.S. Food and Drug Administration (FDA) announced on December 5, 2023, that the outbreak now includes all illnesses reported since ByHeart began production in March 2022. Investigators stated they “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever manufactured.
The outbreak has impacted at least 51 infants across 19 states, with the latest reported illness occurring on December 1, 2023. The U.S. Centers for Disease Control and Prevention (CDC) updated its case definition to include “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release.” This expansion follows initial reports of 39 suspected or confirmed cases of infant botulism identified since August, when the California Infant Botulism Treatment and Prevention Program noted an increase in cases linked to ByHeart formula.
ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, recalled all its products sold in the United States on November 11, 2023. The company represents approximately 1% of the U.S. infant formula market and had been selling about 200,000 cans each month before the recall.
The distressing news regarding potential contamination has affected families nationwide. Andi Galindo, a mother from Redondo Beach, California, reported that her five-week-old daughter, Rowan, was hospitalized with infant botulism in December 2023 after consuming ByHeart formula. Galindo expressed her concerns, stating, “If there is proof that there were issues with their manufacturing… that is a problem, and they really need to be held accountable.”
Another affected parent, Amy Mazziotti from Burbank, California, shared that her then-five-month-old son, Hank, became ill after drinking ByHeart. Mazziotti expressed her relief that the cases are now being recognized in the investigation, noting, “I’ve known in my gut from the beginning that ByHeart was the reason Hank got sick.”
In a statement, ByHeart officials acknowledged their cooperation with federal health authorities, stating that the new cases reported by the CDC and FDA would help inform the company’s investigation into the contamination’s root cause. The FDA sent inspectors to ByHeart’s production facilities in Allerton, Iowa, and Portland, Oregon, last month. However, no results from these inspections have yet been disclosed.
According to ByHeart, independent laboratory tests revealed that 36 samples from three different lots contained the type of bacteria responsible for infant botulism. The company reiterated on its website, “We cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated.”
Dr. Jennifer Cope, a CDC scientist leading the investigation, indicated that the contamination appeared to persist across all production runs, making it challenging to isolate specific lots. The FDA previously issued warnings to ByHeart, citing necessary corrective actions in response to health concerns.
Infant botulism is a rare, but potentially life-threatening condition that affects fewer than 200 babies in the U.S. each year. It occurs when infants ingest botulism spores that germinate in their intestines, producing a toxin that impacts the nervous system. Babies under one year old are particularly vulnerable due to their immature gut microbiomes.
Symptoms of infant botulism can take up to 30 days to manifest and may include constipation, poor feeding, and a “floppy” appearance. The primary treatment for the condition is a medication called BabyBIG, which is derived from the blood plasma of adults immunized against botulism.
As families continue to grapple with the effects of this outbreak, several have initiated lawsuits against ByHeart, alleging that the formula was defective and that the company acted negligently. These lawsuits seek compensation for medical expenses and emotional distress resulting from their children’s illnesses.
The situation raises critical questions about the safety of infant formula products and the oversight necessary to protect vulnerable populations. The ongoing investigation highlights the need for vigilance in food safety protocols to prevent similar outbreaks in the future.
