Clostridium botulinum-contaminatedByHeart-brand formula has sickened at least 23 babies across 13 states. FDA inspection reports and warning letters have come to light showing a history of food safety and hygiene violations at the company’s production facilities.
The outbreak of infant botulism linked to ByHeart infant formula has grown to 23 confirmed cases in 13 states. All infants have been hospitalized, with no deaths reported. The company has issued a recall of all formula products sold nationwide.
ByHeart Inc., the infant formula manufacturer implicated in an ongoing, multistate botulism outbreak, has a history of food safety and hygiene violations at its production facilities, as well as an inadequate root cause analysis in previous incident, per FDA inspection records and warning letters.
The Reagan-Udall Foundation has published a report that captures key insights from stakeholder discussions on ways to improve U.S. infant formula safety and regulation, which were held to support FDA’s “Operation Stork Speed” efforts.
As of November 11, 15 infants have been hospitalized with botulism in 12 states after consuming ByHeart-brand powdered infant formula. The 15 infants who were confirmed to have consumed ByHeart are part of a broader outbreak comprising 84 total cases. A recall has been issued.
The final Make America Healthy Again (MAHA) Report was unveiled in a September 9 press conference led by HHS Secretary Robert F. Kennedy Jr. Food safety, consumer, and environmental stakeholder groups criticize the report’s deregulatory approach and lack of enforceable actions.
This episode of Food Safety Five discusses two scientific developments that could help address the risk posed by Cronobacter in powdered infant formula: an AI-powered analysis of genetic data for C. sakazakii, providing new insight into why it persists in low-moisture foods, and the development of a promising new assay.
Researchers in China have developed a new onsite rapid test, based in fluorescence RNA-targeted isothermal amplification assay (SAT) technology, that can quickly detect and identify Cronobacter species in powdered infant formula. It offers significantly greater sensitivity and much more rapid results than polymerase chain reaction (PCR), without producing false positives.
A recent analysis of French milk and infant formulas has revealed the presence of titanium dioxide—which is banned as a food additive in the EU due to potential toxicity—in all human and animal milk samples, as well as in most infant formula samples. Researchers raise concerns about implications for infant health, and question routes of exposure leading to contamination.
