Botulism outbreak in infant formula linked to milk suppliers

ByHeart formula recall expands as botulism source investigation continues

FDA officials announced on January 23 that a sample of organic whole milk powder collected from a supplier tested positive for Clostridium botulinum, the bacterium that causes botulism. The agency did not immediately identify the supplier. Genetic testing subsequently confirmed that the contaminated powder matched samples taken from an unopened can of ByHeart formula and from a sick infant.

Bill Van Ryn, an owner of Organic West Milk, confirmed last week that the FDA had tested his company’s milk powder and found it positive for the botulism bacterium. He emphasized, however, that contamination did not necessarily originate with his company. “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.”

Organic West Milk Inc. supplies milk from 55 California farmers. The company provided the milk that Dairy Farmers of America, a global dairy cooperative, processed into powder at its Fallon, Nevada facility. The Nevada plant processes about 1.5 million pounds of raw milk daily, converting it into 250,000 pounds of whole milk powder.

In a statement, Dairy Farmers of America confirmed that Organic West supplied the milk for the sample that tested positive. The company said the milk was processed into powder that met all required tests 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 cooperative stated.

ByHeart has recalled all of its products. Organic West has halted sales of milk powder used in any product intended for babies and children until investigators determine the contamination source.

Milk powder is produced by pasteurizing liquid milk, concentrating it through evaporation, and spraying it into a hot chamber, where water evaporates and leaves behind fine, dry milk particles. Botulism spores could potentially contaminate the milk itself or the processing environment during any of these steps.

Kristin Schill, a botulism expert at the University of Wisconsin-Madison, explained the vulnerability of infants to the organism. Healthy adults consume Clostridium botulinum spores every day without becoming sick, she noted. “But babies have immature guts that may not be able to prevent the spores from germinating and growing,” Schill said. Once the spores germinate, they produce a toxin that can cause paralysis and death.

Botulism spores occur naturally in the environment and appear in most foods at low levels. Pasteurization, the standard heat-treatment used to kill most bacteria in milk, does not eliminate botulism spores. Spores can also be present in processing environments.

Federal regulators do not require testing for botulism in infant formula, though some manufacturers voluntarily screen for microbiological indicators that could signal contamination. The risk has historically been considered too low to warrant mandatory testing. This is the first large-scale outbreak of botulism linked to infant formula on record.

The FDA and both companies have emphasized that the investigation into the outbreak remains ongoing. Investigators have not yet determined whether the contamination originated with Organic West’s milk, the processing environment at Dairy Farmers of America, or another stage of production or handling.