Articles Tagged with ''infant formula''

Following the global infant formula recall linked to cereulide contamination, Elena Medo discusses vulnerabilities in infant formula supply chains, infant-specific food safety risks, surveillance gaps, donor milk safety, and the lessons regulators and manufacturers can take away from this unprecedented event.

JEMRA convened in June to review the latest scientific evidence on microbiological hazards that have recently been associated with public health events due to the contamination of powdered infant formula or its ingredients.

The letter to industry was issued in response to the botulism outbreaks linked to Nara Organics and ByHeart formulas, which identified Clostridia in the whole milk powder ingredient supply chain, as well as the global formula recall due to cereulide-contaminated arachidonic acid oil.

An industry that feeds babies must be an industry of absolute transparency. We have nothing to hide, and everything to protect.

Four infants in three states have been hospitalized with botulism after consuming Nara Organics Whole Milk Organic Powdered Infant Formula. California public health officials have detected Clostridium botulinum in an open can of Nara Organics formula collected from the home of an outbreak patient.

This episode of Food Safety Five covers a novel detection method for Clostridium botulinum and a potential new processing approach to mitigate contamination, as well as growing discussion around how C. botulinum should be handled in infant formula manufacturing, spurred by recent botulism outbreaks.

The Trump Administration’s Department of Justice “does not believe in regulation by prosecution,” a spokesperson told the Wall Street Journal, aligning with a May 2025 Executive Order that “strongly discourages” criminal prosecution of any regulatory offense not explicitly identified by the Administration.

ByHeart-commissioned research shows the currently accepted “gold standard” for Clostridium botulinum detection in powdered formula, SRC enumeration, may fail to catch contamination. It is used by many formula brands, including Nara Organics, another company linked to an infant botulism outbreak. Following this finding, third-party IEH Labs developed a novel detection method.

For a time, ByHeart Nutrition and Nara Organics both used Organic West milk dried by Dairy Farmers of America in their infant formula products (confirmed by Food Fix). Both brands have been implicated in botulism outbreaks that occurred within months of each other.

New ByHeart-commissioned research suggests that sulfite-reducing clostridia (SRC) enumeration, the “gold-standard” test for C. botulinum in powdered infant formula, which was used by Nara Organics prior to the ongoing outbreak, is insufficient. Experts who spoke to Food Safety Magazine agree C. botulinum should be considered as a foreseeable hazard requiring specific preventive controls.