ByHeart announced on Thursday that its in-house testing has detected the presence of the bacterium responsible for botulism in its baby formula, amid an ongoing infant botulism outbreak that has seen reported cases double within a week.
As of November 19, there have been 31 cases in 15 states, compared to 15 cases in 12 states the previous week. All affected infants have been hospitalized, though there have been no reported fatalities.
The outbreak, first revealed on November 8, initially saw ByHeart defensively reject any responsibility for the illnesses associated with their product.
The California Department of Public Health (CDPH) was the first to identify a connection between the infant botulism cases and ByHeart products. As the exclusive distributor of the infant botulism treatment BabyBIG worldwide, the CDPH is notified of any infant botulism cases, which began to demonstrate a pattern of exposure to ByHeart formula.
Though ByHeart formula comprises only 1 percent of the market, it was associated with 40 percent of the botulism cases involving dry formula exposure from August 1 to November 10. Preliminary testing by the CDPH confirmed the presence of Clostridium botulinum in an opened can of ByHeart formula from an affected infant's household.
Despite these findings, ByHeart initially resisted the implications. In a video message on social media released on the day the outbreak was announced, co-founder Mia Funt stated, "I want to make something really clear: There is no reason to believe that infant formula can cause infant botulism." Funt asserted that several regulatory authorities have concluded that formula is not a cause of infant botulism, and that the US Food and Drug Administration has not established any "direct connection" between formula and infant botulism cases. She also noted that no "toxins" had been discovered in the company’s formula.