ByHeart Infant Formula Linked to Botulism Outbreak in Babies

A contamination of powdered whole milk used in ByHeart infant formula may be responsible for a significant outbreak of botulism that has affected at least 51 infants across 19 states. U.S. health officials announced these findings on Friday, following extensive testing by the U.S. Food and Drug Administration (FDA).

Laboratory analyses revealed the presence of the botulism-causing bacteria in two samples associated with ByHeart formula. Notably, one sample from an unopened can of the formula matched a strain found in a sick infant. Further investigation uncovered that the bacteria also matched contamination detected in organic whole milk powder used in the formula, which was collected and tested by the company itself.

The FDA’s findings are not definitive, and the investigation is ongoing to pinpoint the exact source of the contamination. “We are focused on the root cause and our responsibility to act on what we’ve learned to help create a safer future for ByHeart and infant formula,” stated Dr. Devon Kuehn, ByHeart’s Chief Scientific and Medical Officer. Despite these developments, neither the FDA nor ByHeart has disclosed the identity of the powdered milk supplier involved in this incident.

The outbreak was initially recognized in November 2023 when officials in California noted a rise in cases of infant botulism linked to ByHeart formula. Since then, the FDA has reported that no new cases have been identified since mid-December. The Centers for Disease Control and Prevention confirmed this information, indicating that the situation may be stabilizing.

After discovering the contamination, ByHeart initially recalled two lots of its formula but later extended the recall to include all products. This action followed findings from the company’s testing, which revealed that six out of 36 samples from three different lots contained the dangerous bacteria.

The outbreak has raised significant concerns among food safety experts, as illnesses caused by botulism bacteria in infant formula are relatively rare. “The size and scope of the ByHeart outbreak is unprecedented,” noted experts in the field.

Currently, some formula companies conduct testing on raw materials and finished products to identify potential contamination. Sarah Sorscher, Director of Regulatory Affairs for the Center for Science in the Public Interest, emphasized the need for mandatory testing. “FDA has not announced a plan to do testing, and that’s what we really want to see them do,” she said.

Legal experts have explained that even if the contamination can be traced back to a milk supplier, ByHeart remains liable for any harm caused by its products. Bill Marler, a food safety lawyer representing families affected by the outbreak, stated, “Just because they are able to point the finger at dried powder as the ingredient that may have been contaminated, it doesn’t take any of the legal or moral responsibility away from ByHeart.”

ByHeart, which captured approximately 1% of the U.S. infant formula market, previously distributed around 200,000 cans of its product each month. The formula, priced at approximately $42 per can, was marketed as a healthy alternative, using “organic, grass-fed whole milk.” Parents seeking nutritious options for their infants chose ByHeart based on its advertised health benefits.

As the situation continues to develop, health officials and consumers alike are calling for improved safety measures in the infant formula industry to prevent future outbreaks. The FDA and ByHeart are currently navigating this crisis, with the health and safety of infants remaining the top priority.

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. The AP is solely responsible for all content.