Powdered whole milk used to make ByHeart infant formula could be a source of contamination that led to an outbreak of botulism that has sickened dozens of babies, U.S.health officials indicated Friday.
Testing by the U.S.Food and Drug Administration found the type of bacteria that can cause the illness in two samples linked to the formula, officials said.
The agency 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.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.The findings are not conclusive, and the investigation continues “to determine the source of the contamination,” the agency said in a statement.
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.Neither FDA nor ByHeart named the supplier of the powdered whole milk.At this time, there is no indication of a broader problem in the infant formula supply, the FDA said.New York-based ByHeart has been at the center of a food poisoning outbreak that has sickened 51 babies in 19 states since December 2023.
The problem was identified in November after officials with the California program that supplies the sole treatment for infant botulism detected a surge in cases in babies who consumed ByHeart formula.No new cases in the outbreak have been identified since mid-December, the U.S.Centers for Disease Control and Prevention said.Popular ReadsMinneapolis ICE shooting live updates: Thousands peacefully protest in the cold4 hours ag...