Considering the infant botulism linked to ByHeart Whole Nutrition Infant Formula, during which product was found on store shelves weeks after the recall was issued, FDA issued a letter to industry describing firms’ legal obligations in the case of a recall, as well as warning letters to four major retailers.
Several tools and data sources are used in signal detection to evaluate genetic and epidemiologic information linked to foodborne outbreak investigations
This article provides background information about FDA’s CORE+EP Signals team's day-to-day work in detecting foodborne illness outbreaks and triaging incidents, and highlights some real-world examples and partnerships that have occurred to improve food safety and protect consumers.
As of December 10, a total of 51 infants are included in the ByHeart formula botulism outbreak. With an expanded case definition, CDC has identified cases that occurred as early as December 2023.
The nationwide infant botulism outbreak associated with ByHeart infant formula has grown to 39 cases in 18 states. All 39 infants were hospitalized; no deaths have been reported.
As of December 2, laboratory-confirmed cases in the ongoing Salmonella outbreak linked to pistachios has reached 155, and CFIA now requires importers and manufacturers of Iranian pistachios to hold and test their products for Salmonella before they can be sold.
An ongoing outbreak of foodborne enterohemorrhagic Escherichia coli (EHEC) O45:H2 infections is sweeping Germany. More than 400 confirmed and possible cases have been reported, with three associated deaths. The vehicle of illness is likely foodborne, but has not yet been identified.
ByHeart Inc. tested its products and found C. botulinum Type A in five of 36 samples across three lots. As of November 26, the outbreak includes 37 cases of infant botulism spanning 17 states. FDA has published inspection documents for ByHeart production facilities confirming a history of food safety issues.
Although the official number of infant botulism cases included in the ByHeart infant formula outbreak remains at 31, the unusual spike in infant botulism treatments recorded by the California Department of Public Health has grown to more than 100, and several babies with exposure to ByHeart formula were treated for botulism as early as November 2024, months ahead of the spike in illnesses.
Although novel data streams like crowdsourced reports and social media posts may allow for rapid identification of foodborne illness events, they can also amplify false signals and lead to inaccurate self-reporting among consumers, as demonstrated in a recent survey.
A multistate salmonellosis outbreak linked to eggs produced by California-based Country Eggs LLC has ended with 105 illnesses, 19 hospitalizations, and no deaths reported.