Amid the ongoing global infant formula recall due to possible cereulide contamination, some countries have reported cases of mostly mild gastrointestinal illness in infants who had consumed infant formula, but confirming cereulide exposure is a challenge.
The first reports from the MAHA-aligned Healthy Florida First initiatives raised concern about toxic heavy metals in infant formula and candy, but toxicologists say a lack of transparency around the methodology and risk assessment makes the findings difficult for experts to interpret and raises questions about the relevance to consumer health.
In the wake of a high-profile safety incidents involving powdered infant formula, FAO/WHO have issued a call for experts and data to support JEMRA in conducting a risk assessment that will help the Codex Committee on Food Hygiene update the Codex Alimentarius standards for powdered formula.
Following the ByHeart botulism outbreak, FDA intends to begin testing infant formula products and ingredients for Clostridium botulinum to help determine whether contamination by the pathogen is a “foreseeable hazard that companies could test for.”
Responding to the global infant formula recall affecting products from Nestlé, Danone, and other producers, the European Food Safety Authority (EFSA) has determined concentrations of cereulide in formula that pose a safety concern to guide risk management decisions that protect public health.
Following a global recall of infant formula products due to cereulide toxin contamination, EU officials are taking steps to prevent illnesses from cereulide-tainted formula in the future. Cases of mild illness associated with recalled product have been reported in Europe.
FDA has shared information about a contaminated ingredient—organic whole milk powder—in the multistate outbreak of infant botulism associated with ByHeart powdered infant formula.
Nestlé says that cereulide, the contaminant behind the recall, does not cause meningitis, the illness for which the infant was hospitalized. UK authorities say no cases of illness associated with Nestlé formula have been clinically confirmed.
An expert panel that was convened to support FDA’s “Operation Stork Speed” emphasizes the need for streamlined FDA approval processes for infant formulas, more transparent ingredient approval processes (i.e., GRAS, food additive petitions), and enforceable limits for environmental contaminants.
Florida unveiled the Healthy Florida First initiative, a MAHA-aligned product contaminant testing effort, alongside the initiative's first report focused on the presence of toxic heavy metals in infant formulas. Several products had elevated levels of arsenic, cadmium, lead, and mercury.
Live: March 3, 2026 at 2:00 pm EST:In this high-level, exclusive webinar, FDA Deputy Commissioner for Human Foods Kyle Diamantas and USDA Under Secretary for Food Safety Mindy Brashears, Ph.D. will share their agencies' regulatory priorities and work plans for 2026 and beyond.