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FDA continues to investigate outbreaks including infant formula and Lucky Charms

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The FDA has closed investigations into three outbreaks, but has left the status “ongoing” for one of them.

In an outbreak of Listeria monocytogenes infections that the Food and Drug Administration began investigating on Feb. 9, the patient count stands at 20. The agency is leaving the status of the outbreak as ongoing, but has closed its investigation.

“The investigation status is now ‘closed’ as of May 18, 2022, because there is not enough evidence to identify a vehicle. The outbreak status is listed as ‘ongoing’ because the most recent date an illness began is April 20, 2022, and it can take several weeks to months for someone to have symptoms of listeriosis after being infected,” according to an update from FDA.

An outbreak of Norovirus linked to the consumption of raw oysters from British Columbia, Canada, has ended and FDA’s investigation has closed. The oysters in question were shipped to 13 states in the U.S. and the Centers for Disease Control and Prevention reports a total of 103 illnesses from the affected states. The Canadian Broadcasting Company reports that the investigation in that county is ongoing with sewage a likely source of the contamination.

The FDA’s investigation into a cronobacter outbreak linked to infant formula from Abbott Nutrition’s Sturgis, MI, production plant has ended, even though the agency continues its work on the situation. The CDC declared the outbreak over as of May 12 with four infants sickened and two dead.

The infant formula plant remains closed but it could reopen in two weeks if a federal court approves a consent decree in which Abbott agrees to operate under strict supervision by the FDA. The closure has fueled a nationwide shortage of infant formula, spurring congressional hearings and calls from the White House for action to resolve the situation as soon as possible while maintaining safety standards. Five strains of cronobacter bacteria have been found in the plant, though none of them are an exact match for the strains that sickened two of the infants. The strains for the other two infants is unknown.

In other outbreak news the FDA continues to investigate reports of “adverse events” in relation to a dry cereal that the FDA has said is Lucky Charms made by General Mills. The patient count has increased to 558, up by three from a week ago. The FDA has begun an on-site inspection and sample testing but has not released any other details about the investigation.

An investigation into an outbreak of Listeria monocytogenes infections from an unknown source continues with the patient count holding steady at 19. The FDA began the investigation on Feb. 13 and has initiated traceback efforts but has not reported what is being traced. The agency has not released any other details about the situation.

One other investigation is ongoing with the FDA and involves a meal replacement drink. Six patients have reported adverse events but the FDA has not reported any other patient details. The agency has begun traceback and sample testing efforts but has not named a specific product.

Additional outbreak information
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 more specific outbreak information.

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