FDA traces contaminated ingredient in ByHeart formula as dairy processors face scrutiny.
The investigation into a rare botulism outbreak linked to ByHeart infant formula has focused on dried milk powder supplied by two U.S. dairy companies, according to reporting by The Associated Press. The outbreak has sickened 51 babies across 19 states, prompting a nationwide recall of all ByHeart products and raising concerns throughout the dairy and infant nutrition sectors.
FDA testing identified organic whole milk powder contaminated with the bacteria that causes botulism. The milk originated from Organic West Milk Inc. in California and was processed into powder at a Dairy Farmers of America (DFA) facility in Fallon, Nevada. While the contaminated sample genetically matched bacteria found in finished ByHeart formula and in sick infants, regulators stressed that the precise point of contamination has not yet been determined.
Organic West Milk, which sources milk from 55 farmers, said it exclusively supplied organic whole milk powder to ByHeart for infant formula use. Company owner Bill Van Ryn emphasized that no definitive link has been proven between the milk powder and the outbreak, suggesting the contamination could have occurred during processing or later stages of formula production. The company has paused sales of milk powder intended for children as a precaution.
Dairy Farmers of America confirmed that the FDA-tested sample came from milk supplied by Organic West and stated that the powder met all regulatory requirements at the time of processing. The cooperative, which processes roughly 1.5 million pounds of raw milk per day at the Nevada plant, highlighted that manufacturers of finished consumer products are responsible for ensuring ingredient safety during final production.
Experts note that Clostridium botulinum spores are widespread in the environment and can survive pasteurization, appearing in milk and processing facilities at low levels. While harmless to healthy adults, these spores pose a serious risk to infants due to their underdeveloped digestive systems. Although botulism spores have been detected in infant formula before, this is the first large-scale outbreak tied to the product, challenging long-held assumptions about risk and testing protocols in the dairy-based infant formula supply chain.
Source: The Associated Press – https://apnews.com/article/byheart-west-milk-dairy-farmers-of-america-cdbc131b7e1c144a2635f369739d62f2
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