Capitalising on Trump’s Make America Healthy Again agenda, the new US company ByHeart has been promoting its infant formulas direct to consumers via global platforms such as Amazon, claiming its products are pure, healthy,  “filled with ingredients backed by breast milk science in every scoop”  and have undergone  ‘rigorous testing going above and beyond what is required’  Through such marketing ByHeart’s formula market has grown fast and spread to Canada, Africa, the Arab world, Asia and Latin America.

The ByHeart story is a lesson in deception. The U.S. Food and Drug Administration (FDA) has investigated ByHeart factories since its launch in 2022, and has found multiple safety violations,  leaking roof, mold in a water tank, 2,500 dead flies –  enough to raise  an Official Action Indicated (OAI) red flag, its highest tier of concern.  Now,  ByHeart’s infant formula has been identified as the cause of at least 39 cases of potentially deadly infant botulism in 18 US states with a further 70 infants under investigation.

ByHeart says that it has recalled the products and admits all could be contaminated.  However, the products are still onsite in some stores and what about online sales outside the US? The single treatment for infants is only available in the US on ‘a case-by-case evaluation basis.’

IBFAN is calling for a global recall, mandatory reporting of infections, a revision of Codex and WHO’s Food Safety Guidelines and a new World Health Assembly Resolution – calling on all governments to urgently implement the International Code.

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IBFAN is gravely concerned by the recent outbreak of potentially deadly infant botulism that seems to be linked to Clostridium botulinum contamination of powdered infant formula (PIF) manufactured by the new US-Based company ByHeart.¹ The US Food and Drug Administration (FDA) has determined that ByHeart’s PIF is the source of at least 39 cases of infant botulism in an outbreak spread across 18 US states. All 39 of the infected babies have been hospitalised and another 70 cases are under investigation.² ByHeart has admitted that all of its products could be contaminated with Clostridium botulinum Type A and that it is focused on finding the root cause from suppliers and raw ingredients to packaging and transportation.³ ⁴

IBFAN is calling for full transparency, a rapid independent investigation, mandatory reporting of infections in national systems⁵ and a revision of Codex and WHO’s Food Safety Guidelines. This should be reinforced by a new World Health Assembly Resolution that highlights the food safety risks of online formula promotion, especially into the Global South and settings where the risks are greater and access to treatment is reduced.

IBFAN’s thoughts are with the sick infants, affected families and the health workers caring for the children.

ByHeart’s online marketing reaches the Global South with limited treatment options

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ByHeart was launched in March 2022, during the US national formula shortage that followed the recall of contaminated Abbott Nutrition formulas. ByHeart capitalised on the Trump administration’s agenda to Make America Healthy Again, using misleading and idealized claims that the products were purer and “filled with ingredients backed by breast milk science in every scoop.”

Through direct marketing to consumers via on-line social media platforms such as Amazon, UBuy and Desertcart, ByHeart’s formula market grew quickly, spreading to Canada, Africa, the Arab world, Asia and Latin America, exacerbating their use in the Global South where Botulism diagnosis and treatment is more difficult to access.⁶

Summary of ByHeart’s Contamination problems

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In 2022 the FDA led an investigation into ByHeart because of suspected Cronobacter sakazakii contamination.⁷ ByHeart’s admission that a batch of PIF had tested positive for Cronobacter led to the recall of five batches in December 2022.⁸

In August 2023 the FDA warned ByHeart: “You did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment, as required by 21 C.F.R. 106.55(a).”⁹

December 2023 the FDA raised an Official Action Indicated (OAI) red flag, its highest tier of concern after finding multiple safety violations in ByHeart’s Pennsylvania factory, including a leaking roof, mold in a water tank and 2,500 dead flies in a food production area.¹⁰ ¹¹

November 2025: Dr. Erica Pan, a leading public health expert, noted an increase of infant botulism cases from August 1st. Dr. Pan said that the number of infected infants who had consumed ByHeart formula jumped out at her, because the company’s sales account for only about 1 percent of the national formula market. “So that was a very disproportionate, very concerning signal of what’s going on here”. The FDA investigated ByHeart’s facilities in Allerton, Iowa and Portland, Oregon. The FDA found that ByHeart’s Pennsylvania factory violated its own rules for maintaining the temperatures needed to eliminate bacteria from the formula before it was sent for packaging. ByHeart also failed to report variations in temperature to a supervisor before the formula was sent out to be fed to its infant customers.¹²

Congresswoman Rosa DeLauro¹³ from Connecticut’s Third Congressional District sent a letter to FDA Administrator Marty Makary, demanding that all inspection records of the company’s infant formula manufacturing factories be released to Congress.¹⁴ ByHeart initiated a nationwide recall of all its formulas following the outbreaks but in December, the products are found to be still on sale in some stores.¹⁵

IBFAN’s Call to Action

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1. A full, independent investigation with publication of findings: Governments must ensure public funding for routine environmental surveillance and commercial-free third-party testing of PIF manufacturing facilities. Independent public health experts must have full access and all findings, including negative results, should be made public and stored in a centralised data base.
2. An internationally available register of all infants diagnosed with suspected foodborne, bacterial or viral illness must be created for all concerned including parents.
3. Accountability and legal remedy for affected families: Any regulatory enforcement actions must be pursued swiftly and fairly and companies held accountable for the medical, financial and legal costs of the treatment of harmed infants and parental leave for their care.
4. The WHO/FAO INFOSAN network must continue to warn national safety authorities. The WHO Guideline on the Safe preparation, storage and handling of powdered infant formula must be updated to address the fact that ‘the preparation step’ (relating to pathogens such as Enterobacteriacea, Cronobacter and Salmonella species) will not be effective in de-activating the heat-resistant spores of Clostridium botulinum. While the immediate feeding and discarding of unused formula remains critical, the reconstitution of PIF at the necessary high temperatures could negatively impact the nutrient content.
5. The Codex Committee on Food Hygiene (CCFH) must address the manufacturing issue. CCFH will meet in December 2025 and should update the Code of Hygienic Practice on Powdered Formulae for Infants and Young Children.¹⁶ The Codex Code of Ethics in International Trade and Food Aid¹⁷ forbids the international trade of any food (including re-exported food) which is unsafe, unsuitable, poisonous, harmful or otherwise injurious to health or “is labelled or presented in a manner that is false, misleading or deceptive.”
6. Member States should adopt a new World Health Assembly Resolution to highlight the food safety risks of online commercial promotion and sale of formula products that are not registered or regulated at national level. All transactions must fully comply with the International Code of Marketing of Breastmilk Substitutes and subsequent relevant WHA resolutions (referred together as the ‘Code’). Code implementation, with appropriate warnings on labels and the removal of all idealisation and promotional claims is necessary beyond food safety. Misleading marketing practices undermine breastfeeding and increase the number of infants dependent on formula and exposed to its multiple risks.
7. Governments and health workers should implement the Code, the WHO/UNICEF Global Strategy for Infant and Young Child Feeding,¹⁸ the Baby Friendly Hospital Initiative (BFHI) and Nurturing Care Framework in service provision.¹⁹ Governments should also recognise parent’s rights to maternity protection and leave.
8. Ensure preparedness and appropriate responses for the protection of Maternal Infant and Young Child Feeding in Emergencies following the Operational Guidance on Infant Feeding in Emergencies.²⁰ Build capacity for social behaviour change that protects breastfeeding, re-lactation, wet-nursing, human milk banking and cup feeding.
9. Social media platforms must be required to maintain nationally domiciled legal entities that can monitor and pursue breaches of regulations. Licencing mechanisms must include Code compliance for all entities within their jurisdiction.

Legal Action so far

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Currently, two families whose infants contracted infantile botulism after consuming ByHeart PIF are suing the company, alleging that the recalled formula was defective and that ByHeart was negligent in producing and in selling it. These families are seeking financial compensation for medical bills, emotional distress, and other damages.²¹ It is likely that more infants will contract botulism and more families may initiate lawsuits, with the potential of nationwide litigation, similar to the necrotizing enterocolitis (NEC) case.²² The Brazilian sanitary authority (ANVISA) has prohibited the importation and sale of ByHeart powdered formula 720 ml in Brazil. INFOSAN, the joint FAO/WHO network of the national food control authorities, issued a global alert warning about this issue on 19 November to all 190 INFOSAN food safety authority members and updates are being provided as new information becomes available. The FDA has put out warnings to a number of countries, but there has been no systematic global mandatory recall or warning system as yet. E-commerce makes the importation of individual orders much harder to trace.

Conclusion

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This outbreak highlights again systemic failures in PIF production surveillance, regulatory oversight, recall systems and crisis communication, that are exacerbated by commercial promotion globally online. PIF is NOT sterile; it requires strict manufacturing controls, transparent testing and rapid warning and support for families.²³

IBFAN calls on ByHeart to cooperate with the FDA, State Health Departments and independent experts. To prevent repeated crises that leave large numbers of infants vulnerable to illness and death from contamination or from the growing shocks that disrupt formula supply chains, reliance on formula must be reduced and breastfeeding rates protected and increased through full implementation of the Code.

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 also with regard to exports to other countries.

Footnotes

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