Powdered whole milk could be a culprit in the ByHeart botulism outbreak, tests show

An outbreak of infant botulism, sickening 51 babies across 19 states since December 2023, has been linked to powdered whole milk used in the production of ByHeart infant formula. Testing conducted by the U.S. Food and Drug Administration (FDA) revealed the presence of the botulism-causing bacteria in both an unopened can of ByHeart formula and in samples of the organic whole milk powder used to manufacture it.

Tracing the Contamination

The FDA’s investigation, which remains ongoing, found a match between the bacteria in the formula, the milk powder supplied to ByHeart, and a sample taken from a sickened infant. While the findings are not yet conclusive, they strongly suggest the powdered whole milk as a potential source of the contamination. ByHeart initiated a recall of two lots in November, later expanding it to include all products manufactured since the company’s launch in March 2022.

Did You Know? Illnesses caused by botulism bacteria in infant formula are rare, and the scale of this outbreak is unprecedented, according to food safety experts.

A “Watershed Moment” for ByHeart

Dr. Devon Kuehn, ByHeart’s chief scientific and medical officer, described the situation as a “watershed moment” for the company, emphasizing a commitment to identifying the root cause and preventing future occurrences. However, neither the FDA nor ByHeart has publicly identified the supplier of the contaminated powdered whole milk. The company previously sold approximately 200,000 cans of formula per month, marketing it as a premium option utilizing “organic, grass-fed whole milk” and appealing to parents seeking alternatives close to human breast milk.

The outbreak was initially identified after a California program supplying the sole treatment for infant botulism observed a surge in cases among babies consuming ByHeart formula. Fortunately, the CDC reports no new cases have been identified since mid-December.

Expert Insight: The focus on a raw ingredient supplier highlights the complexities of supply chain management in the food industry. Even with stringent quality control measures, contamination can occur at various stages, underscoring the need for robust testing protocols and traceability systems.

Legal and Regulatory Implications

Bill Marler, a food safety lawyer representing over 30 families affected by the outbreak, asserts that ByHeart retains legal and moral responsibility despite the potential involvement of a supplier. Sarah Sorscher, director of regulatory affairs for the Center for Science in the Public Interest, advocates for mandatory testing of both raw materials and finished formula, noting that the FDA has not yet announced a plan for comprehensive testing.

Frequently Asked Questions

What caused the outbreak of infant botulism?

The FDA investigation indicates that powdered whole milk used to make ByHeart infant formula is a potential source of contamination with the bacteria that causes botulism.

How many babies have been affected?

As of the latest reports, 51 babies in 19 states have been sickened by botulism since December 2023, linked to ByHeart formula.

Is the broader infant formula supply at risk?

The FDA has stated that, at this time, there is no indication of a broader problem in the infant formula supply.

What steps will ByHeart and the FDA take to prevent similar incidents in the future remains to be seen, but further investigation into the supply chain and potential regulatory changes could be forthcoming.