Two companies made dried milk powder linked to botulism in ByHeart baby formula

Two dairy companies have been implicated in the botulism outbreak linked to ByHeart infant formula that has sickened 51 babies across 19 states, according to new information obtained by The Associated Press.

Organic whole milk powder that tested positive for Clostridium botulinum bacteria was sourced from Organic West Milk Inc., a California-based company, and processed at a Dairy Farmers of America plant in Fallon, Nevada. However, officials emphasize that the ultimate source of contamination remains under investigation.

Bill Van Ryn, an owner of Organic West Milk, confirmed that the FDA found botulism bacteria in a sample of his company’s milk powder. Despite this discovery, Van Ryn cautioned against premature conclusions.

“Nothing has been proven about our milk yet,” Van Ryn said. “Something happened in the process of converting the milk to powder and then in converting it to baby formula.”

The company, which sources milk from 55 organic farmers, has taken precautionary measures by suspending sales of milk powder used in products intended for infants and children until investigators pinpoint the contamination source. Van Ryn noted that ByHeart was their only infant formula client for organic whole milk powder.

Powdered milk production involves pasteurizing liquid milk, concentrating it through evaporation, and spray-drying it in a hot chamber that removes water, leaving behind fine milk particles. This process is standard in the dairy industry but requires strict quality controls.

The implicated Dairy Farmers of America facility in Nevada is a significant operation, processing approximately 1.5 million pounds of raw milk into 250,000 pounds of whole milk powder daily. The dairy cooperative acknowledged in a statement that Organic West supplied the milk used in the sample that tested positive but emphasized that the processed powder met all required testing standards before Organic West sold it to ByHeart.

“Manufacturers of end-use consumer products have a responsibility to properly process ingredients to ensure product safety,” the Dairy Farmers of America stated, suggesting potential issues in subsequent handling or processing.

On January 23, FDA officials announced that a sample of organic whole milk powder from a supplier had tested positive for botulism bacteria, though they did not identify the supplier at that time. The agency determined this sample was a genetic match to contamination found in a finished can of ByHeart formula.

Further testing revealed that bacteria in an unopened can of formula matched a sample from a sick baby. This contamination also matched bacteria detected in milk powder samples used in ByHeart’s manufacturing process. ByHeart has since recalled all its products but has declined to identify the source of those specific milk powder samples.

Kristin Schill, a botulism expert at the University of Wisconsin-Madison, explained that Clostridium botulinum spores are common environmental contaminants found at low levels in most foods. While healthy adults can consume these spores without ill effects, infants have underdeveloped digestive systems that may allow the spores to germinate, produce toxins, and cause potentially fatal paralysis.

“Spores can be found everywhere, including in milk, though typically at low levels,” Schill noted. The pasteurization process used in dairy production doesn’t eliminate these heat-resistant spores, which can also be present in processing environments.

This outbreak marks an unprecedented event in the infant formula industry. Although botulism spores have been detected in infant formula before, this is the first major outbreak linked to commercial formula products. Currently, regulatory requirements don’t mandate specific testing for botulism in infant formula, though some manufacturers voluntarily implement screening procedures for potential microbial contamination.

As the investigation continues, health authorities are working to determine exactly where in the supply chain contamination occurred and how to prevent similar incidents in the future.