Poor manufacturing processes, lack of warnings, misleading claims and marketing through social media are not only a serious food safety risk for infants, they also undermine breastfeeding, increasing the number of infants who are unnecessarily dependent on formula.

Codex Committee on Food Hygiene CCFH55  15 -19 December 2025 | 
Nashville, Tennessee, United States of AmericaIBFAN Statement on ByHeart   CRD15IBFAN, ENCA and the WPHNA (1) is joining the Codex Committee on Food Hygiene  the UN food standard-setting body that adopts Guidelines and Codex standards that form the basis of national legislation.  We are calling for mandatory independent monitoring and accountability and stricter manufacturing safeguards to eliminate the risk of infant exposure to Botulinum spores.  51 infants in the USA – the only country where the treatment for botulism is easily available – have been diagnosed and hospitalised with Botulism and the U.S Food and Drug Administration (FDA) has determined that the outbreak is linked to powdered infant formula (PIF) made by the new US company, ByHeart. (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, 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.”  

The ByHeart story is a lesson in deception. FDA investigations of ByHeart factories since 2022 have found multiple safety violations: leaking roof; mold in a water tank; 2,500 dead flies, failure to take action to eliminate rodent issues –  enough problems to raise an Official Action Indicated (OAI) red flag, its highest tier of concern.  Despite this, the ByHeart formula market has grown fast not only in the USA but in Canada, Africa, the Arab world, Asia and Latin America.(4)   Since the USA is the only country where treatment for Botulism is easily available caregivers of infants diagnosed with botulism outside of the US need to go through a time consuming, costly and onerous  process to acquire it. Any delays increase the risk of paralysis and death of infants, especially in the global south where access to health care is often reduced. The global online sales increase the risks and affected infants will be difficult to track.
Poor manufacturing processes, lack of warnings, misleading claims and marketing through social media are not only a serious food safety risk for infants, they also undermine breastfeeding, increasing the number of infants who are unnecessarily dependent on formula.

Elisabeth Sterken, IBFAN Regional Coordinator for North America:  
“To prevent repeated crises that leave large numbers of infants vulnerable to illness and death from contamination, reliance on formula must be reduced and breastfeeding rates protected and increased through full implementation of the International Code of Marketing of Breast-milk Substitutes and Resolutions. The US Government must act now to ensure that ByHeart and all US-based companies are required to follow the Code, not only within the United States but with regard to all exports of baby feeding products. Until this happens companies have the freedom to market as they wish.” 

Patti Rundall,

Policy Director, IBFAN Global Advocacy

Baby Milk Action/IBFAN UK,
Cambridge   UK

www.babymilkaction.org

www.ibfan.org

www.babymilkaction.org/news/policy
http://www.babymilkaction.org/tigers

UK Member of the International Baby Food Action Network (IBFAN), a global network of over 300 groups in 114 countries. www.ibfan.orgMember of the Conflict of Interest Coalition: 162 public interest organisations representing over 2000 NGOs, united by the common objective of safeguarding public health policy-making against commercial conflicts of interests.  The Conflict of Interest Network (COIN) is the formally constituted organisation that builds on the Conflict of Interest Statement.Member of the Baby Feeding Law Group a coalition of leading health professional and lay organisations working to  bring UK and EU legislation in line with World Health Assembly Resolutions. https://www.bflg-uk.org

Patron of First Steps Nutrition Trust and independent public health nutrition charity that provides information and resources to support eating well from pre-conception to five years. www.firststepsnutrition.org

Member IBFAN’s Codex team, representative of the European Network of Childbirth Associations (ENCA) and the International Association of Consumer Food Organisations (IACFO)

Member of the interagency collaboration Infant and Young Child Feeding in Emergencies Core Group    the  IFYCFEhub. Is a global portal to resources related to infant and young child nutrition in humanitarian contexts.
Operational Guidance on Infant and Young Child Feeding in Emergencies.  The IFYCE repository