October 25, 2021

FDA Issues Details of General Mills E. coli Outbreak Investigation

The FDA has issued details of their investigation into the E. coli O121 outbreak linked to recalled General Mills flour. Flour is not an ingredient most people connect with food poisoning, but it is a raw agricultural product and can be contamianted with pathogenic bacteria.

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One of the problems with recalls of flour is that many people do not keep this product in its original packaging. Most decant the flour into another container and discard the wrapping. But three people who were sickened in this outbreak kept the flour in its packaging, and helped the government track down the culprit in this outbreak.

Multiple signals from the FDA’s Coordinated Outbreak Response and Evaluation (CORE) network started coming in. The CDC identified a string of illnesses that started in December 2015 as an outbreak of Shiga toxin-producing E. coli O121. This is a fairly rare outbreak, since most E. coli outbreaks are caused by E. coli O157 bacteria.

Investigators first thought that produce or another food was the source of the outbreak. But in April, after the people who were sickened had been interviewed, investigators found that all of those patients had been baking at home. Many of them said they used Gold Medal flour, and had eaten raw cookie dough made with that flour. Unfortunately, reports from some patients couldn’t be confirmed because they no longer had the paper bags the flour was packed in.

But three people still had the original packaging. Two of the labels revealed that the Gold Medal flour was packaged at a facility in Kansas City, Missouri on consecutive days. The third was made at the same plant within a week.

The FDA team also learned that restaurants supplied balls of raw dough for kids to play with while they waited for their food. Children who had played with that dough at different restaurants in separate states were part of the outbreak. That flour was also supplied by the same General Mills facility.

FDA and CDC investigators briefed General Mills about the information, and four days later the firm voluntarily recalled 10,000,000 pounds of the flour produced over a three week period in November and December of 2015.

Laboratory analysis confirmed the presence of E. coli O121 in a flour sample from a home of a patient. On June 10, 2016, FDA’s whole genome sequencing analysis confirmed that the bacteria was closely related genetically to the bacteria that had made people sick.

The outbreak has not been updated by the CDC since June 1, 2016. Stay tuned and we will keep you informed about this outbreak, recalls, and more information.

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