However, concerning levels of arsenic and lead were detected in some products, and Consumer Reports is therefore urging FDA to set limits for these metals in infant formula. PFAS were also found in more than a quarter of products.
FDA has declared the outbreak over with 48 confirmed and probable cases of illness. A root-cause investigation is still ongoing. FDA has also announced new “Operation Stork Speed” infant formula resources for families.
Arachidonic acid oil (AHA oil) from a Chinese supplier was identified as the source of cereulide toxin contamination in infant formula produced by Nestlé and other well-known
brands. Imports of Chinese AHA oil are now subject to stricter EU border checks.
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.
On Demand: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.