The FDA has logged more than 500 complaints of “adverse events” related to a “dry cereal” in an investigation of an ongoing outbreak. 

Although the agency does not name the cereal in its outbreak table, it has previously confirmed to Food Safety News that it is investigating complaints about Lucky Charms breakfast cereal. The FDA has not reported where the ill people live, what their ages are, or what “adverse events” have been reported.

As of May 4, the Food and Drug Administration had received 529 reports of what it describes as adverse events. That’s up from 446 a week ago and 231 the previous week.

Since late 2021, the crowd sourcing website has received 6,400 reports from people complaining of classic food poisoning symptoms of nausea, vomiting and diarrhea after eating Lucky Charms cereal. General Mills, the maker of the cereal, has said that is has investigated the situation and there is no apparent link between the reported illnesses and Lucky Charms.

The FDA has begun on-site inspections and sample collection and testing, but it has not reported what location is involved.

Bill Marler, a Seattle food safety attorney, told The Guardian that the cereal may not be the culprit.

“Correlation is not necessarily causation,” he told The Guardian. “People try to connect the dots between something that’s happening and something that’s known, but the connection may not necessarily be accurate. 

“There are hundreds of thousands of people today in the United States that are having vomiting and diarrhea, from a bunch of different causes. And it also may be happening that some of those thousands of people also happen to eat Lucky Charms. And now they’re seeing it in the news and they’re going: ‘Hey, wait a second. I had diarrhea a week ago, and I ate Lucky Charms. Therefore, it had to be the Lucky Charms.’ ”

Marler said in some outbreaks, many people may be right about the link between their symptoms and a particular food product – while many others are wrong about the same thing. He described a 2007 outbreak in which several hundred people got sick from salmonella detected in Peter Pan peanut butter. 

“But we got 5,000 phone calls. And the vast majority of them were people who go, ‘Well, no, I didn’t have any medical treatment,’ ” Marler said.

“You knew that there was a clear outbreak link to a product. But then you still had thousands of people presuming that they got sick from eating the product. And they probably did not.”

Marler also said some people posting online about a connection between their symptoms and a source are absolutely right, and social media such as can be a useful tool for getting to the root of a problem.

Other outbreak news
Two other outbreaks, both involving infections from Listeria monocytogenes, remain under investigation. the FDA reported the first on Feb. 9 and the second on April 13. The patient counts are currently at 18 and 19, respectively.

For the Listeria outbreak first posted on Feb. 9, the FDA has initiated traceback, on-site inspections and sample collection and testing. However, the agency continues to list the cause of the outbreak as undetermined and has not released any details about what products are being traced or where the on-site inspections are being conducted.

For the Listeria outbreak initially reported on April 13, the FDA has begun traceback efforts, but no other investigation details have been released. The cause remains undetermined.

Other ongoing investigations
The FDA continues to investigate an outbreak of norovirus associated with oysters from Canada. The Centers of Disease Control and Prevention is assisting with the investigation and most recently reported 103 patients spread across 13 states. Recalls have been initiated and traceback efforts are ongoing.

In an outbreak of “adverse events” related to a meal replacement drink the FDA reports that six people have been affected. The agency first reported the outbreak on March 30. It has begun traceback and sample testing efforts but has not named a specific product.

In an outbreak of coronobacter infections, the FDA is continuing to investigate infant formula produced by Abbott Nutrition at its Sturgis, MI, plant. At least four babies have been infected and two have died. Recalls for certain Similac products and other formulas have been initiation and production at the plant has been shut down.

The table below shows information about outbreak investigations being managed by FDA’s CORE Response Teams. The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion. The table below has been abbreviated to show only active investigations.

A public health advisory will be issued for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves, according to the FDA. Please direct your attention to those pages for the most up to date information on the investigation and for consumer protection information.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

To view the FDA page with links to specific information on individual outbreaks, please click here.

Click on table to enlarge. Use link above to go to the FDA page with links to specific outbreak information.

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Editor’s note: Bill Marler is the publisher of Food Safety News.