ByHeart announced on Thursday that its own testing identified the bacterium that causes botulism in its baby formula, which is linked to an ongoing infant botulism outbreak that has doubled since last week.
As of November 19, there have been 31 cases across 15 states—up from 15 cases in 12 states reported last week. All 31 cases so far have been hospitalized. No deaths have been reported.
The outbreak was announced on November 8, and ByHeart was, at first, unusually aggressive in deflecting blame for linked illnesses.
The link between infant botulism cases and ByHeart was first spotted by the California Department of Public Health (CDPH). The department is the world’s sole source of the infant botulism treatment BabyBIG, and, as such, is contacted when any infant botulism cases arise. CDPH started to notice a pattern of ByHeart exposure among the cases. While ByHeart products account for just 1 percent of infant formula sales, babies fed ByHeart formula accounted for 40 percent of infant botulism cases with dry formula exposure between August 1 and November 10. Soon, preliminary testing by the department identified the bacterium that causes botulism—Clostridium botulinum—in an opened can of ByHeart from one of the sick babies.
Changing tune
However, ByHeart didn’t buy it. In a video posted to social media the day the outbreak was announced, one of ByHeart’s co-founders, Mia Funt, said: “I want to make something really clear: There is no reason to believe that infant formula can cause infant botulism.” Funt claimed that “multiple regulatory bodies” have concluded that formula can’t cause infant botulism, and the US Food and Drug Administration has never found a “direct connection” between formula and infant botulism. She added that no “toxins” have been found in the formula.
ByHeart voluntarily recalled two batches of formula on November 8, but said the decision “was made purely out of caution, to go above and beyond what’s required and ensure the highest level of safety.”
On November 10, the company pressed the FDA to test unopened cans of its formula, suggesting that CDPH’s positive finding was due to contamination.
Things have changed since then. On Wednesday, the company said that it had partnered with an independent food-testing company, and the results were in: “We have just learned that those tests identified Clostridium botulinum in some samples of ByHeart formula.”
The company recommends that parents immediately stop using its formula products, all of which have been recalled. “ByHeart has grown because parents trusted us, and we are committed to rebuilding your trust,” it said.
The company also acknowledged that it has expanded the list of potential contaminants for its formula: “Until now, this bacterium was not among the pathogens routinely tested for across the industry,” ByHeart wrote. It emphasized that it is now cooperating with the FDA and working with others to figure out how its formula became contaminated.
The FDA said it is still testing the products and investigating the outbreak.
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