Powdered whole milk used to make ByHeart infant formula could be the source of contamination that led to an outbreak of botulism that sickened dozens of babies.
The Centers for Disease Control and Prevention (CDC) reported the details on Friday.
Powdered whole milk may be culprit in botulism outbreak
What we know:
Testing by the U.S. Food and Drug Administration (FDA) found that bacteria in an unopened can of formula matched a sample from a sick baby — and it also matched contamination detected in samples of organic whole milk powder used to make ByHeart formula and collected and tested by the company, officials said.
FDA testing also found contamination in a sample of whole milk powder supplied to ByHeart — and it matched the germ in a finished sample of the company’s formula.
What they’re saying:
A ByHeart official said the finding helps shed light on what has become 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,” said Dr. Devon Kuehn, ByHeart’s chief scientific and medical officer.
What we don’t know:
While these results advance the agency’s understanding of the outbreak, the FDA said the findings are not conclusive, and the investigation continues “to determine the source of the contamination.”
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