In December, the Codex Committee on Food Hygiene (CCFH) decided to initiate work related to the control of Clostridium botulinum in powdered infant formula.

The decision, prompted by the ongoing infant botulism outbreak linked to ByHeart-brand infant formula sold across the U.S., was made at the 55^th Session of CCFH (CCFH55), which took place December 15-19, 2025 in Nashville, Tennessee.

Specifically, CCFH decided to request the Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Meetings on Microbiological Risk Assessment (JEMRA) to conduct a risk assessment on spore-forming pathogens, including C. botulinum and Bacillus cereus, in powdered infant formula.

Additionally, CCFH will ask JEMRA to 1) update the existing risk assessment and scientific advice on Cronobacter and Salmonella in powdered infant formula and 2) provide other relevant scientific advice that would inform recommendations on strengthened control measures across infant formula production, covering all stages from primary production and packaging through to the reconstitution of the product, and including environmental monitoring programs.

The decision was backed by the International Baby Food Action Network (IBFAN), which is calling for mandatory independent monitoring and accountability in national food regulatory systems and stricter manufacturing safeguards to mitigate the risk of infant exposure to C. botulinum spores from contaminated infant formula. IBFAN has raised concerns about gaps in the safety of powdered infant formula revealed by the ongoing ByHeart infant botulism outbreak, which, as of December 29, has affected 51 infants across 19 U.S. states.

IBFAN asserts that Codex Alimentarius guidelines should be revised to reduce the food safety risk of C. botulinum in powdered infant formula manufacturing.

The group also asked that revisions to the Codex Guidance Code of Hygienic Practice for Powdered Formula for Infants and Young Children (CXC 66-2008) include warnings about the food safety risks about global online marketing and sales of powdered infant formula—another issue exemplified in the ByHeart botulism outbreak—forbidding any messaging that is not in compliance with WHO’s International Code of Marketing of Breast Milk Substitutes.

IBFAN argues that ByHeart Inc. has been “capitalizing on President Trump and [U.S. Health Secretary Robert F. Kenny Jr.’s] Make America Healthy Again (MAHA) agenda, promoting its infant formulas direct to consumers and via global platforms such as Amazon, with misleading claims, including that the products have undergone ‘rigorous testing going above and beyond what is required’ and are purer, healthier, and ‘filled with ingredients backed by breast milk science in every scoop.’” ByHeart made these claims despite years of food safety failures at ByHeart production facilities, revealed in U.S. Food and Drug Administration (FDA) inspection documents, including mold, dead insects, leaking roof issues, and past Cronobacter sakazakii product contamination.