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.
Three babies in three states have been sickened in the second infant botulism outbreak identified since late-2025. All patients were fed Nara Organics Whole Milk Infant Formula. A recall has been issued, and product testing is underway.
Following a high-profile, global recall of infant formulas due to cereulide contamination in early 2026, the European Commission is drafting an act that would introduce additional checks for the toxin in formulas.
The New York bill is awaiting the Governor’s signature, while the California bill advances from the Assembly to the Senate. The bills would require baby food and infant formula manufacturers to regularly test their products for toxic heavy metals and disclose results.
FDA did not identify deficiencies in ByHeart’s production facilities that could explain the outbreak, but a powdered milk ingredient did test positive for C. botulinum. ByHeart is developing an action plan based on data generated from the investigations.
On May 26, Vermont Governor Phil Scott signed into law two bills related to food chemical safety; specifically, the nation’s first state-level ban on paraquat (H.739) and legislation setting heavy metals testing and disclosure requirements for baby food manufacturers (H.536).
Young child formula, commonly referred to as “toddler milk,” is widely marketed for use in young children’s diets. FSANZ assessments indicate there is a need for greater regulatory clarity to ensure product composition, labeling, and representation consistency.
The guidance was developed to help manufacturers and laboratories in the design, conduct, evaluation, and reporting of Protein Efficiency Ratio (PER) studies.
Samples were tested for arsenic, cadmium, lead, mercury, PFAS, pesticides, and phthalates/plasticizers. When toxic heavy metals were detected in some samples, it was at levels far below EPA drinking water limits.
At the upcoming 49th Session of the Codex Committee on Food Labeling (CCFL49), CCFL will consider draft guidelines on applying food labeling provisions during emergencies. Infant and maternal health groups oppose these guidelines, saying they could harm vulnerable populations.
