ByHeart stopped making infant formula following the outbreak linked to its products, but its co-founders started a new company, MeridianMade, which has entered into an agreement to acquire Perrigo’s infant formula business—raising questions about safety and market consolidation.
The company will pay the U.S. and states for “knowingly manufacturing infant formula purchased with taxpayer dollars [under state Medicaid and WIC programs] in an environment that put the products at unacceptable risk of microbial contamination.”
Prompted by a global food safety incident and infant formula recalls spanning 99 countries, the European Commission has drafted a regulation that would set a limit of 1 µg/kg cereulide toxin in dried formula products. The draft regulation is open for public feedback.
Considering the unprecedented ByHeart and Nara Organics infant botulism outbreak and with a focus on dairy ingredients, participants emphasized the need for prevalence research, more sensitive and standardized testing, data-sharing, validated preventive controls, and coordinated industry action.
Regulation (EU) 2026/1825 expands MLs for 3-monochloropropanediol (3-MCPD) and glycidyl fatty acid esters, and Regulation (EU) 2026/1890 establishes new MLs for furan, 2-methylfuran, and 3-methylfuran.
The Nara Organics infant botulism outbreak has ended, with four sick in three states. Whole genome sequencing (WGS) findings and a shared powdered milk supplier/processor indicate a common source of contamination with the 2025 outbreak linked to ByHeart infant formula.
Following the global infant formula recall linked to cereulide contamination, Elena Medo discusses vulnerabilities in infant formula supply chains, infant-specific food safety risks, surveillance gaps, donor milk safety, and the lessons regulators and manufacturers can take away from this unprecedented event.
JEMRA convened in June to review the latest scientific evidence on microbiological hazards that have recently been associated with public health events due to the contamination of powdered infant formula or its ingredients.
The letter to industry was issued in response to the botulism outbreaks linked to Nara Organics and ByHeart formulas, which identified Clostridia in the whole milk powder ingredient supply chain, as well as the global formula recall due to cereulide-contaminated arachidonic acid oil.
