Botulism outbreak prompts new work on Codex infant formula guidance
Codex Committee on Food Hygiene CCFH55
15 -19 December 2025Nashville, Tennessee, USA
Public Health advocates warmly welcomed the decision by the Food Hygiene Committee (CCFH55) of the Codex Alimentarius to conduct risk assessment on Clostridium botulinum, a newly exposed risk of powdered infant formula and to update its scientific advice on Cronobacter and Salmonella.(1) The decision was supported by WHO, FAO, the EU, the USA and many countries.
The concern follows an outbreak in the USA with 51 infants diagnosed and hospitalised with botulism that the U.S Food and Drug Administration (FDA) and CDC consider is likely to be linked to powdered infant formula (PIF) made by the new US Company ByHeart (2) The FDA and CDC have advised parents and caregivers to discard all ByHeart formula (3) and shopkeepers and supermarkets to take it from the shelves, an advice not consistently followed (4).
The treatment for botulism is not readily available and needs hospitalisation in an intensive care unit yet ByHeart has been promoting and selling its infant formulas direct to consumers via global platforms such as Amazon to the whole world, using misleading claims 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.”
Delegates from dozens of countries gathered in Nashville for CCFH55, the UN global body that develops standards that form the basis of national legislation and are used as benchmarks in trade disputes. IBFAN and ENCA, two of the very few Codex observers who are not funded by the food industry, joined the meeting to call for the safeguards to require stricter manufacturing safeguards and independant controls. They also called for any revised Guidance to warn of the food safety risks of global online marketing and sales, specifically forbidding messaging that is NOT in compliance with WHA recommendations, something already implied by the Codex Code of Ethics in International trade and Food Aid. Restriction on misleading marketing are important to protect breastfeeding and reduce dependence on the use of these unsafe products.
Also on the CCFH55 agenda were issues such as the Manufacturing of Cell-Based Foods and the Control of Salmonella in chicken meat. IBFAN and ENCA called for the inclusion of mandatory requirements that monitoring, verification and accountability systems should be independent from commercial industries and Trade Associations. On the Cell Based Foods, they expressed caution about the risks to infant health, warned about claims implying that products are the same as breastmilk and requested that before work is started Codex should develop Principles for the Risk Analysis of New Food Sources and Production Systems (NFPS), taking much greater care over the conflicts of interest by vested scientific advice related to foods.
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Notes
(1) FAO is including Clostridium botulinum in its work on toxigenic clostridia in infant foods.
(2) ByHeart was launched in March 2022, during the US national formula shortage that followed the recall of contaminated Abbott Nutrition formulas. Since then ByHeart has been capitalising on President Trump and Secretary Kennedy’s Make America Healthy Again agenda
(3) December 17, 2025 The FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism. Epidemiologic and laboratory analyses indicate that ByHeart Whole Nutrition infant formula is the source of this multistate outbreak of infant botulism. FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula https://www.fda.gov/news-events/press-announcements/fda-takes-action-improve-recall-effectiveness-following-infant-botulism-outbreak-investigation