Organic whole milk powder linked to the ByHeart baby formula outbreak—which has sickened 51 infants in 19 states—tested positive for the bacteria that causes botulism, according to the Associated Press. The contaminated powder was supplied by Organic West Milk Inc., a California company, and processed at a Dairy Farmers of America facility in Fallon, Nevada, though officials said the source of the contamination remains unknown.
The discovery marks the first large outbreak of botulism linked to infant formula in the United States, raising questions about safety testing and oversight of formula ingredients as the investigation continues.
Investigation Continues Into Contamination
Organic West Milk Inc. and the Dairy Farmers of America stand at the center of an investigation into how botulism bacteria entered ByHeart baby formula. The two companies processed and supplied the milk powder now linked to an outbreak that has affected infants across 19 states.
A milk powder sample collected by the FDA from Organic West Milk tested positive for Clostridium botulinum, the bacterium that causes botulism. The same powder was processed at a Dairy Farmers of America facility in Fallon, Nevada, then sold to ByHeart for use in infant formula. The FDA determined the sample matched contamination found in finished formula and in samples from sickened babies.
Both companies have said that investigations are ongoing and the exact source of contamination has not been identified.
“Nothing has been proven about our milk yet,” said Bill Van Ryn, an owner of Organic West Milk. Van Ryn suggested the contamination may have occurred during processing: “Something happened in the process of converting the milk to powder and then in converting it to baby formula.”
The Dairy Farmers of America said in a statement that the milk powder it processed from Organic West milk met all required tests before being sold to ByHeart. The Nevada plant processes approximately 1.5 million pounds of raw milk daily into 250,000 pounds of whole milk powder.
Organic West Milk supplied the powder only to ByHeart for infant formula products, according to company officials. The company halted sales of all milk powder intended for babies and children pending further investigation.
Why Infants Face Risk
Botulism spores are found throughout the environment and typically appear in most foods at very low levels. Healthy adults consume Clostridium botulinum spores every day without becoming ill.
Infants face a different vulnerability. “Babies have immature guts that may not be able to prevent the spores from germinating and growing,” said Kristin Schill, a botulism expert at the University of Wisconsin-Madison. Once spores germinate, they produce a toxin that can cause paralysis and death.
Pasteurization, the standard safety process used on milk before it becomes powder, does not kill botulism spores. The spores can survive the heating process and may also be present in processing environments.
Botulism spores have appeared in infant formula previously, but this outbreak is the first large one linked to the product. Despite the known risk, the FDA does not require manufacturers to test for botulism in infant formula, though some companies voluntarily conduct microbiological screening.
The Outbreak and Recall
ByHeart infant formula has recalled all of its products. The outbreak has sickened 51 babies in 19 states. The investigation by the FDA and the companies continues to determine how the contamination entered the supply chain and what additional safety measures may be warranted.
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