A serious outbreak of infant botulism linked to contaminated ByHeart baby formula has resulted in the hospitalization of 51 infants across 19 states, according to the U.S. Food and Drug Administration (FDA). This alarming development was reported on December 3, 2023, marking an increase from 39 cases reported earlier in the month.
The outbreak, which began with illnesses reported between August 9 and November 19, has prompted federal health officials to take decisive action. All affected infants were hospitalized after consuming ByHeart powdered formula. Fortunately, there have been no reported fatalities associated with this outbreak to date. The states impacted include Arizona, California, Illinois, Kentucky, Massachusetts, and New Jersey, among others, with Ohio being the latest to report a case.
The FDA has confirmed that it has not received any reports of recalled formula being found on store shelves since November 26, 2023. The agency emphasized that all ByHeart infant formula products have been recalled and should no longer be available for sale. This includes all cans and single-serve “anywhere pack” sticks.
ByHeart, which holds about 1% of the U.S. infant formula market, had been selling approximately 200,000 cans of its product monthly prior to the outbreak. Federal agencies, including the FDA and the Centers for Disease Control and Prevention (CDC), are currently conducting additional testing, with results expected in the upcoming weeks.
Investigation and Health Impact
California health officials have confirmed that a sample from an open can of ByHeart formula, which had been fed to an ill infant, tested positive for the bacterium responsible for botulism. Dr. Erica Pan, California’s state health officer, described the testing process, which involves injecting laboratory mice with the cultured bacterium. The results indicated that the mice became ill quickly, affirming the presence of the toxin.
This outbreak has affected infants aged from two weeks to five months. Symptoms of botulism can take weeks to manifest and may include poor feeding, loss of head control, drooping eyelids, and a flat facial expression. The sole available treatment, known as BabyBIG, is an intravenous medication produced from pooled blood plasma of adults immunized against botulism. According to the CDC, all affected infants have received this treatment, which costs approximately 69,300 USD per vial.
Infant botulism is a rare but serious disease, typically affecting fewer than 200 infants annually in the United States. The illness is caused by a type of bacterium that produces a toxin in the intestines, often spread through spores found in the environment. Infants are particularly susceptible due to their underdeveloped gut microbiomes, which make it difficult for them to prevent the spores from germinating and producing the toxin. Exposure can occur through contaminated honey, dust, or water.
Company Response and Market Implications
In response to the crisis, ByHeart released a statement on its website, affirming that it is conducting rigorous testing with an independent laboratory to ensure safety. The company stated, “From the very beginning, we have acted quickly and decisively to remove any potential risk.” They urged parents and caregivers to stop using the recalled products and dispose of them immediately.
Despite the seriousness of this outbreak, experts suggest that there is little danger of significant infant formula shortages. ByHeart’s market share is relatively small compared to the broader industry. This situation contrasts sharply with the widespread formula shortages experienced in 2021 and 2022, when a different contamination incident involving Abbott Nutrition led to severe market disruptions.
In 2022, ByHeart had previously recalled five batches of formula after detecting the presence of cronobacter sakazakii at their packaging facility. Following this recent incident, the FDA has issued warnings to the company regarding necessary corrective actions.
As the investigation continues, health officials remain vigilant in monitoring the situation and ensuring the safety of infant products. Parents are urged to stay informed and to dispose of any ByHeart products they may have at home.
