ByHeart Infant Formula Linked to Botulism Outbreak in Babies

Health officials in the United States indicated on Friday that powdered whole milk used in ByHeart infant formula may be responsible for a botulism outbreak that has affected dozens of infants. Testing conducted by the U.S. Food and Drug Administration (FDA) revealed the presence of the bacteria associated with botulism in two samples connected to ByHeart formula.

Officials identified a match between bacteria found in an unopened can of ByHeart formula and a sample from a sick infant. Additionally, contamination was detected in samples of organic whole milk powder supplied to ByHeart, as well as in the final product. The FDA’s preliminary findings do not conclude the investigation, which aims to uncover the precise source of the contamination.

In a statement, Dr. Devon Kuehn, ByHeart’s chief scientific and medical officer, referred to this moment as a “watershed moment” for the company. “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,” Kuehn stated. Neither the FDA nor ByHeart has disclosed the identity of the powdered milk supplier.

The FDA has noted that there is currently no evidence of a widespread issue affecting the overall infant formula market. ByHeart, based in New York, has faced scrutiny after reports emerged that 51 infants across 19 states became ill since December 2023 due to the formula. The outbreak was initially identified in November when a spike in cases was detected in babies who had consumed ByHeart products.

Since mid-December, no new cases related to this outbreak have been reported, according to the Centers for Disease Control and Prevention (CDC). In response to the situation, ByHeart initially recalled two lots of formula but subsequently expanded the recall to include all products. Federal health officials have stated that contamination could not be ruled out for any products manufactured since the company began operations in March 2022.

Notably, a company test revealed that six out of 36 samples from different lots contained the bacteria responsible for infant botulism. Experts assert that illnesses caused by botulism bacteria in infant formula are rare, making the scale of the ByHeart outbreak unprecedented.

While some formula manufacturers conduct testing on raw materials and finished products for potential contamination, Sarah Sorscher, director of regulatory affairs for the Center for Science in the Public Interest, emphasized the need for mandatory testing protocols. “The FDA has not announced a plan to do testing, and that’s what we really want to see them do,” Sorscher remarked.

Legal expert Bill Marler, who represents over 30 families affected by the outbreak, pointed out that regardless of the source of contamination, ByHeart retains moral and legal responsibility for any harm caused by its products. “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,” Marler stated.

ByHeart’s formula, marketed as a close alternative to human breast milk and made with “organic, grass-fed whole milk,” previously accounted for approximately 1% of the U.S. infant formula market, with sales reaching around 200,000 cans monthly. Parents chose ByHeart products for their perceived health benefits, with each can priced at about $42.

The ongoing investigation highlights the critical importance of safety standards in the infant formula industry, as parents rely on these products to nourish their vulnerable children.